Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive HBcAb test.
Participant has active hepatitis B infection as determined by NAAT or surface antigen assay. Participants who have acquired immunity from past exposure (HBcAb positive / HBsAb positive / HBsAg negative) are eligible.
Seropositive for or active viral infection with hepatitis B virus (HBV):\r\n* Hepatitis B surface antigen (HBsAg) positive\r\n* HBsAg negative, anti-hepatitis B surface antibody (HBs) positive and/or anti-hepatitis B core antibody (HBc) positive and detectable viral deoxyribonucleic acid (DNA)\r\nNotes:\r\n* Subjects who are HBsAg negative, anti-HBs positive, and/or anti-HBc positive, but viral DNA negative are eligible\r\n* Subjects who are seropositive because of HBV vaccination are eligible (HBV surface antibody positive, HBV core antibody negative, and HBV surface antigen negative)
Presence of positive test results for hepatitis B virus (HBV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibody\r\n* Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation\r\n* Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody [HBcAb] and negative HBsAg) may be included if HBV deoxyribonucleic acid (DNA )is undetectable. These patients must be willing to undergo monthly DNA testing
Positive hepatitis serology:\r\n* Hepatitis B virus (HBV): Patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or hepatitis B virus core antibody (anti-HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management\r\n** Patients with positive hepatitis B surface antigen (HBSAg) consistent with prior vaccination to HBV (i.e., hepatitis B virus surface antibody [anti-HBs]+, anti-HBc-) may participate\r\n** Patients suspected to have false positive serologic studies because of IV immunoglobulin administration are potentially eligible after negative PCR studies for viral DNA/ribonucleic acid (RNA) and discussion with the principal investigator\r\n* Hepatitis C virus (HCV): Patients with positive hepatitis C serology unless HCV RNA is confirmed negative and may be considered for inclusion in the study on a case-by-case basis (e.g., patients with negative viral load after HCV-specific treatment)
Presence of positive test results for hepatitis B virus (HBV), hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibody\r\n* Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation\r\n* Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody [HBcAb] and negative HBsAg) may be included if HBV deoxyribonucleic acid (DNA) is undetectable; these patients must be willing to undergo monthly DNA testing
Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
The HBV DNA test will be performed only for patients who have a positive HBcAb test
Active hepatitis B infection (defined as the presence of detectable hepatitis B virus [HBV] deoxyribonucleic acid [DNA] or hemoglobin E [HBe] antigen). Patients who are hepatitis B surface antigen (HBsAg) negative/hepatitis B surface antibody (HBsAb) positive but hepatitis B core antibody (HBcAb) positive are eligible, provided HBV DNA is negative. These patients must have monthly monitoring of HBV DNA for the duration of the study
Positive hepatitis serology:\r\n* Hepatitis B virus (HBV): Patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or hepatitis B virus core antibody (anti-HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management\r\n* Hepatitis C (HCV): patients with positive hepatitis C serology unless HCV ribonucleic acid (RNA) is confirmed negative and may be considered for inclusion in the study on a case-by-case basis
Subjects with chronic infection by HCV who are treated or untreated are allowed on study; subjects with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test and negative HBV deoxyribonucleic acid (DNA) test at screening, are eligible for the study; in addition, subjects with successful treatment (defined as sustained virologic response [SVR] or SVR) are allowed as long as  weeks have passed between completion of HCV therapy and start of study drug
Hepatitis B (HBV) or hepatitis C (HCV) infection. Patients positive for Hepatitis B surface antigen (HBsAg or HBcAb) will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy. Patients positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
Hepatitis B (HBV) or hepatitis C (HCV). Patients positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy. Patients positive for anti- HCV antibody will be eligible if they are negative for HCV-RNA
Serologic status reflecting active hepatitis B or C; patients with hepatitis B (HBV) antibody positive but who have positivity for hepatitis B surface antigen (HBsAg) or anti hepatitis B core antibody (anti-HBc) and patients who are positive for anti-hepatitis C (HCV) will need to have a negative polymerase chain reaction (PCR) (viral HBV deoxyribonucleic acid [DNA] or HCV ribonucleic acid [RNA]) result prior to enrollment; those who are HBsAg positive or HBV DNA positive and those who are positive for HCV (RNA) will be excluded
Specific guidelines will be followed regarding inclusion of relapsed/refractory DLBCL based on hepatitis B serological testing as follows:\r\n* Hepatitis B surface antigen (HBsAg) negative, hepatitis B core antibody (HBcAb) negative, hepatitis B surface antibody (HBsAb) positive patients are eligible\r\n* Patients who test positive for HBsAg are ineligible (regardless of other hepatitis B serologies)\r\n* Patients with HBsAg negative, but HBcAb positive (regardless of HBsAb status) should have a hepatitis B virus (HBV) deoxyribonucleic acid (DNA) testing done and protocol eligibility determined as follows:\r\n** If HBV DNA is positive, the subject will be excluded from the study\r\n** If HBV DNA is negative, the subject may be included but must undergo at least every  months HBV DNA polymerase chain reaction (PCR) testing from the start of treatment throughout the duration the treatment course
Positive serology for HBV defined as a positive test for HBsAg; in addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HepB DNA test will be performed and if positive the subject will be excluded
Negative serologies for hepatitis B (HB) defined as a negative test for HB surface antigen (sAg); in addition, if negative for HBsAg but HB core antibody (cAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed and if negative, patient may be included but must undergo hepatitis B virus (HBV) DNA polymerase chain reaction (PCR) testing at the beginning of treatment and throughout treatment duration, at least every  months; in addition patients will require treatment with Entecavir . mg orally (PO) a day (qday) per Memorial Sloan Kettering Cancer Center (MSKCC) institutional guidelines
Subjects with chronic hepatitis B or C as defined as test subjects with positive hepatitis (Hep) B serology:\r\n* Subjects with a negative hepatitis B virus surface antigen (HBsAg) and a positive hepatitis B core antibody (HBcAb) require an undetectable/negative hepatitis B deoxyribonucleic acid (DNA) (e.g., polymerase chain reaction [PCR] test) to be enrolled, and will require prophylactic antiviral treatment (e.g., F) initiated prior to the first dose of study drug, and continued until approximately  to  months after completion of study drug(s)
Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag)) or hepatitis C infection. For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded. Subjects with positive serology but negative hepatitis C virus (HCV) ribonucleic acid (RNA) test results are eligible.
Patients with positive serology for hepatitis B (HB), defined as a positive test for HB surface antigen (HBsAg), are NOT eligible; if negative for HBsAg but HB core antibody (HBcAb) positive a HB deoxyribonucleic acid (DNA) test will be performed; if HB DNA test is positive the patient is NOT eligible; NOTE: patients who are positive for HBcAb but negative for hepatitis B virus (HBV) antigenemia and viremia (HBsAg negative and HB DNA test negative) may be eligible for the study, but should be referred to hepatology for consultation and must be started on HBV suppression therapy with lamivudine or equivalent anti-HBV agents throughout the treatment and for a year after the completion of the treatments; these patients need to have liver function tests (LFTs) and HBV viral titer monitoring at least monthly during the treatment and for a year after treatment completion
Positive hepatitis serology:\r\n* Patients with positive serology for hepatitis B defined as positivity for hepatitis B virus surface antigen measurement (HBsAg) or anti-hepatitis B core total antibodies (antiHBc) may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing hepatitis B virus (HBV) DNA testing by real-time polymerase chain reaction (PCR) monthly during the study\r\n* Patients with positive hepatitis B surface antigen (HBsAg) consistent with prior vaccination to HBV (i.e., hepatitis B immune status/anti-hepatitis B surface antibody [anti-HBs+], anti-HBc-) may participate\r\n* Patients suspected to have false positive serologic studies because of intravenous (IV) immunoglobulin administration are potentially eligible without need for further monitoring if they have negative PCR studies for viral DNA/RNA after discussion with the principal investigator \r\n* Patients with positive hepatitis C serology are excluded unless they have negative hepatitis C virus (HCV) ribonucleic acid (RNA) testing after receiving HCV-specific treatment and the case is discussed with the principal investigator
Hepatitis B virus (HBV): negative hepatitis B surface antigen (HBsAg) and negative hepatitis B core (HBc) antibody or positive HBc and negative HBV deoxyribonucleic acid (DNA) by quantitative PCR
HBsAg positive
HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral DNA
Subjects who are HBsAg negative, anti-HBs positive, and/or anti-HBc positive, but viral DNA negative are not eligible
No evidence of active hepatitis B or C infections (hepatitis B surface antigen positive [HBsAg +], hepatitis B deoxyribonucleic acid [DNA] positive by polymerase chain reaction [PCR], or anti-hepatitis C virus [HCV] antibodies); hepatitis core antibody (HBcAb) seropositive patients that are HBsAg negative are eligible if they are closely monitored for evidence of active hepatitis B virus (HBV) infection by HBV DNA testing and receive suppressive therapy with lamivudine or other HBV suppressive therapy until  months after the last rituximab dose
Except in cohort , HPV-associated cancers, active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening; patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test and negative HBV deoxyribonucleic acid (DNA) test at screening, are eligible for the study
Have current or prior positive test results for human immunodeficiency virus (HIV) or hepatitis B (HBV) or C. Subjects who have positive HBV test results due to having been previously vaccinated against hepatitis B, as evidenced by negative hepatitis B surface antigen (HBsAg), negative anti- hepatitis B core protein (HBc) and positive antibody to the HBsAg (anti-HBs) are not excluded
Specific guidelines will be followed regarding inclusion of relapsed/refractory DLBCL based on hepatitis B serological testing as follow:\r\n* Hepatitis B surface antigen (HBsAg) negative, hepatitis B virus core antibody (HBcAb) negative, hepatitis B virus surface antibody (HBsAb) negative patients are eligible\r\n* HBsAg negative, HBcAb negative, HBsAb positive patients are eligible\r\n* Patients who test positive for HBsAg are ineligible\r\n* Patients with HBsAg negative, but HBcAb positive (regardless of HBsAb status) should have a hepatitis B virus (HBV) deoxyribonucleic acid (DNA) testing performed and protocol eligibility determined as follow:\r\n** If HBV DNA is positive, the subject is ineligible\r\n** If HBV DNA is negative, the subject may be included but must undergo HBV DNA polymerase chain reaction (PCR) testing monthly x  months beginning from the start of treatment
Presence of positive test results for hepatitis B virus (HBV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibody\r\n* Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation\r\n* Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody [HBcAb] and negative HBsAg) may be included if HBV DNA is undetectable; these patients must be willing to undergo monthly DNA testing
Hepatitis B virus (HBV): patients with positive serology for hepatitis B defined as positivity for hepatitis B virus surface protein antigen (HBsAg) or anti-hepatitis B virus core antibody (HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management
Positive hepatitis serology:\r\n* Hepatitis B virus (HBV): patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management\r\n** Patients with positive HBSAg consistent with prior vaccination to HBV (i.e., anti-HBs+, anti-HBc-) may participate\r\n** Patients suspected to have false positive serologic studies because of IV immunoglobulin administration are potentially eligible after negative PCR studies for viral DNA/ribonucleic acid (RNA) and discussion with the principal investigator\r\n* Hepatitis C (HCV): patients with positive hepatitis C serology unless HCV RNA is confirmed negative and may be considered for inclusion in the study on a case-by-case basis (e.g., patients with negative viral load after HCV-specific treatment)
For patients with unknown hepatitis B virus surface antigen (HbsAg) status, must be tested during study screening; patients who are tested positive test for HBsAg are excluded if they have inadequately controlled hepatitis B and/or Child-Pugh Class B or C cirrhosis; however, patients with adequately controlled hepatitis are not excluded from the study if they satisfy all of the following criteria: (i) must be receiving a nucleoside analog anti-viral drug for  or more months; and (ii) have a serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) level of less than  IU/ml via polymerase chain reaction quantification assays prior to enrollment
Positive hepatitis serology: (a) Participants with positive serology for hepatitis B, defined as positivity for hepatitis B surface antigen (HBsAg), or participants who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive, (b) Participants positive for anti-HBc, but with negative hepatitis B Virus (HBV) deoxyribonucleic acid (DNA), will be considered for inclusion by the Medical Monitor on a case-by-case basis in order to ensure feasibility of monthly DNA testing and availability of appropriate care in case of hepatitis B reactivation, (c) Participants with positive serology for hepatitis C (HCV) unless HCV (by ribonucleic acid [RNA]) is confirmed negative
Positive serology for hepatitis B (HB) defined as a positive test for HB surface antigen (HBsAg); in addition, if negative for HBsAg but HB core antibody (HBcAb) positive (regardless of HB surface antibody [HBsAb] status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded\r\n* If HB virus (HBV) DNA is negative, subject may be included but must undergo HBV DNA polymerase chain reaction (PCR) testing at least every  months from the start of treatment until  months post treatment; prophylactic antiviral therapy may be initiated at the discretion of the investigator
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B virus surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of hepatitis B surface antibody [HBsAb] status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded; HBsAg negative, HBsAb negative, HBsAb positive subjects can be included\r\n* Consult with a physician experienced in care & management of subjects with hepatitis B to manage/treat subjects who are anti-HBc positive\r\n* Monitoring criteria for HBcAb+ and HBV DNA negative subjects:\r\n** If HBV DNA is negative, subject may be included but must undergo at least every  month HBV DNA polymerase chain reaction (PCR) testing from the start of treatment during the treatment course\r\n** Monitoring during the follow-up period will be performed during routine study visits for a minimum follow-up period of six months after the last dose, as long as the subject remains on study; monitoring frequency during follow-up should occur at a minimum of every - months; whenever possible, the monitoring should occur as part of the routine follow-up visit (Note: for most studies, the follow-up visits are  month post-dose,  months post-dose and  months post-dose\r\n** Prophylactic antiviral therapy may be initiated at the discretion of the investigator
Clinically active hepatitis B defined as positive hepatitis B surface antigen (HBsAg); or positive hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) viral load; patients who are HBcAb with undetectable HBV DNA viremia are eligible
Hepatitis B or C. All subjects must be screened for hepatitis B and C up to  days prior to study drug start using the hepatitis virus panel laboratorial routine. Subjects positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; subjects positive for HCV IgG will be eligible if they are negative for HCV RNA.
Hepatitis B or C. All subjects must be screened for hepatitis B and C up to  days prior to study drug start using the hepatitis virus panel laboratorial routine. Subjects positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; subjects positive for HCV IgG will be eligible if they are negative for HCV-RNA.
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg) and a detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) viral load; if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of hepatitis B surface antibody [HBsAb] status), a HBV DNA test will be performed and if positive the subject will be excluded; if HBV DNA is negative, subject may be included but must undergo at least every -month HBV DNA polymerase chain reaction (PCR) testing from the start of treatment during the treatment course; prophylactic antiviral therapy may be initiated at the discretion of the investigator
Specific guidelines will be followed regarding inclusion of MCL based on hepatitis B serological testing as follows:\r\n* Hepatitis B surface antigen (HBsAg) negative, hepatitis B core antibody (HBcAb) negative, hepatitis B surface antibody (HBsAb) positive MCL patients are eligible\r\n* Patients who test positive for HBsAg are ineligible (regardless of other hepatitis B serologies)\r\n* For MCL patients with HBsAg negative, but HBcAb positive (regardless of HBsAb status), should have hepatitis B virus (HBV) deoxyribonucleic acid (DNA) testing done and protocol eligibility determined as follows:\r\n** If HBV DNA is positive the subject is excluded\r\n** If HBV DNA is negative, patient may be included but must undergo at least every  months HBV DNA polymerase chain reaction (PCR) testing from the start of treatment throughout the duration the study\r\n** Monitoring during the study is required at least every  months and during follow-up at a minimum of every - months up to  months after the last dose\r\n** Prophylactic antiviral therapy with lamivudine (TC) or investigators preferred antiviral regimen throughout protocol therapy and for - months thereafter may be initiated at the discretion of the investigator\r\n** If the patients HBV DNA becomes positive during the study, the investigator should manage the clinical situation as per the standard of care of participating institution; the investigator should weigh the risks and benefits of continuing ofatumumab or discontinuing ofatumumab before appropriate treatment decisions are made for that individual patient
Positive serology for hepatitis B (HB) defined as a positive test for HBsAg; in addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a hepatitis B DNA test will be performed and if positive the patient will be excluded
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B virus HBsAg surface protein antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B virus core antibody (HBcAb) positive and hepatitis B surface antibody (HBsAb) negative, a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded; Note: if patient HBcAb positive and HBsAb positive, which is indicative of a past infection, the subject can be included; patients who are seropositive because of hepatitis B virus vaccine are eligible; consult with a physician experienced in care & management of subjects with hepatitis B to manage/treat subjects who are anti-HBc positive
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg); patients with prior history of hepatitis B infection, but immune, with only immunoglobulin (Ig)G hepatitis core antibody + (HBcAb +) must be checked for hepatitis B virus titers by polymerase chain reaction (PCR) and if the viral load is undetectable may be enrolled; these patients must receive anti-viral prophylaxis, such as lamivudine  mg orally (PO) daily (or an equivalent) starting at least one week prior to cycle  and continued through the completion of treatment and for  months after the last dose of ofatumumab; hepatitis B virus titers by quantitative PCR and HBsAg should be checked every month (+/-  week) while on therapy and every  months (+/-  month) thereafter for  months after the last ofatumumab dose; in the event of an early termination of the clinical trial for any reason, a treating physician will be determining the frequency and the length of follow up studies of hepatitis B virus titers and HBsAg status; it is recommended that the patient remains on prophylactic lamivudine or an equivalent, as above, regardless of whether the study was continued or terminated; in addition, if appropriate consultation with a hepatologist should be obtained
Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HGsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded; consult with a physician experienced in care & management of subjects with hepatitis B to manage/treat subjects who are anti-HBc positive
Positive serology for hepatitis B virus (HB) defined as a positive test for hepatitis B surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of hepatitis B surface antibody [HBsAb] status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive, the patient will be excluded; consult with a physician experienced in care and management of subjects with hepatitis B to manage/treat subjects who are anti-HB positive
Positive hepatitis serology:\r\n* Hepatitis B virus (HBV): patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or anti-hepatitis B core antibody (HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management\r\n* Hepatitis C (hepatitis C virus [HCV]): patients with positive hepatitis C serology unless HCV ribonucleic acid (RNA) is confirmed negative and may be considered for inclusion in the study on a case-by-case basis
Chronic or active hepatitis B or C (patients positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; patients positive for HCVAb will be eligible if negative for HCV-RNA)
Known Human Immunodeficiency Virus, or serological evidence for Hepatitis B (positive hepatitis B surface antigen [HBsAg]), or chronic Hepatitis C infection. For subjects who are negative for HBsAg, but Hepatitis B core Antibody [HBcAB] positive, a HBV DNA (viral load) test will be performed and if negative are eligible. Subjects with positive Hepatitis C antibody serology with a negative HCV ribonucleic acid (RNA) test results are eligible.
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B virus surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B virus core antibody (HBcAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded
Positive hepatitis B surface antigen (HBsAg); if HBcAb is positive, Hepatitis B deoxyribonucleic acid (DNA) by polymerase chain reaction (PCR) will be evaluated; positive anti hepatitis B core antibody (HBcAb) with an undetectable viral load does not exclude the patient
Known positive hepatitis serologies:\r\n* Hepatitis B (HBV): patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management\r\n* Hepatitis C (HCV): patients with positive hepatitis C serology unless HCV ribonucleic acid (RNA) is confirmed negative and may be considered for inclusion in the study on a case-by-case basis
HBsAG positive
Participants demonstrating any one of the following will be excluded:\r\n* Positive hepatitis B surface antigen (HBsAg) or\r\n* Positive anti-HBc IgM\r\n* Positive anti-HBc IgG\r\n* Positive HBV polymerase chain reaction (PCR)
DONOR: Participants demonstrating any one of the following will be excluded:\r\n* Positive hepatitis B surface antigen (HBsAg) or\r\n* Positive anti-HBc IgM\r\n* Positive anti-HBc IgG\r\n* Positive HBV PCR
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded if unable to tolerate and/or receive anti-hepatitis-B therapy; positive serology because of prior vaccination is allowed
Positive serology for Hepatitis B (HB) defined as a positive test for Hepatitis B surface antigen (HBsAg). In addition, if negative for HBsAg but Hepatitis B core antibody (HBcAb) positive, a Hepatitis B Virus (HBV) DNA test will be performed and if positive the subject will be excluded.
Positive serology for Hepatitis B (HB) defined as a positive test for Hepatitis B surface antigen (HBsAg). In addition, if negative for HBsAg but (Hepatitis B core antibody (HBcAb) positive (regardless of Hepatitis B surface antibody [HBsAb] status), a HB DNA test will be performed and if positive the subject will be excluded. If HBV DNA is negative, subject may be included but must undergo HBV DNA monitoring. Prophylactic antiviral therapy may be initiated at the discretion of the investigator.
Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
Active uncontrolled infection, including Hepatitis B, Hepatitis C infection. Patients with anti-HBc positive, or HBsAg but DNA negative are exception(s)
Active hepatitis B virus (HBV) defined by positive hepatitis B surface antigen (HBsAg) test at screening; patients with past or resolved HBV infection (defined by a negative HBsAg test and a positive anti-hepatitis B core antigen [anti-HBc] antibody test) are eligible; HBV deoxyribonucleic acid (DNA) must be obtained in these patients prior to first day of study treatment
subjects with anti-hepatitis B core antibody but with undetectable HBV DNA and negative for HBsAg
Positive test for HbsAg, or positive test for HBcAb (unless serology is positive due to recent intravenous immunoglobulin therapy). HBcAb positivity will be allowed if HBsAb is present.
Positive test for human immunodeficiency virus (HIV) -I or -II antibodies, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody (unless HCV viral load test by PCR is negative). HBcAb positivity will be allowed if one or more of the following is true: a) HBsAb is present; b) hepatitis B DNA testing is negative and the patient is receiving hepatitis B reactivation prophylaxis with entecavir, tenofovir, or lamivudine