Patient must not have active (chronic or acute) hepatitis B virus (HBV) infection as evidenced by testing performed within days prior to registration; patients with past or resolved HBV infection are eligible; active HBV is defined as having a positive hepatitis B surface antigen (HBsAg) test; past or resolved HBV is defined as having a negative HBsAG test and a positive total hepatitis B core antibody (HBcAb) test; patient must not have active hepatitis C virus (HCV) infection as evidenced by testing performed within days prior to registration; active HCV is defined as having a positive HCV antibody test followed by a positive HCV RNA test
Positive for hepatitis C virus (HCV) antibody at screening
Significant acute or chronic infection including, among others: Known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (defined as, HBV surface antigen positive and HBV core antibody positive with reflex to positive HBV DNA or HBV core antibody positive alone with reflex to positive HBV DNA or positive HCV antibody with reflex to positive HCV RNA).
Current or history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection: positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or HCV antibody at screening
Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
Active infection requiring therapy, positive tests for Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) positive or Hepatitis C virus (HCV) antibody positive at screening must not be enrolled until further definite testing with Hepatitis B virus (HBV) DNA titers and HCV RNA tests can conclusively rule out presence of active infection.
Known hepatitis C virus (HCV) antibody positive.
Hepatitis C virus (HCV) antibody positive
Significant acute or chronic infections including, among others:\r\n* Known history of testing positive for human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS).\r\n* Active tuberculosis.\r\n* Positive test for hepatitis B virus (HBV) surface antigen (and/or core antibody) and/or confirmatory hepatitis C virus (HCV) RNA (if anti-HCV antibody tested positive).
Significant acute or chronic infections including, among others: a. Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome. b. Active hepatitis B virus (HBV) (HBV surface antigen positive) or hepatitis C virus (HCV) (HCV RNA positive). c. Subjects with known active tuberculosis (history of exposure or history of positive tuberculosis test plus presence of clinical symptoms, physical or radiographic findings).
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive)
Significant acute or chronic infections including, among others: a) Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome; b) Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (HBV surface antigen positive and HBV core antibody positive with reflex to positive HBV DNA or HBV core antibody positive alone with reflex to positive HBV DNA or positive HCV antibody with reflex to positive HCV ribonucleic acid [RNA]); c) Subjects with active tuberculosis (history of exposure or history of positive tuberculosis test plus presence of clinical symptoms, physical or radiographic findings).
Known history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or detectable HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive)
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive.
Active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening\r\n* Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody test at screening, are eligible for the study\r\n* Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test at screening; the HCV RNA test will be performed only for patients who have a positive HCV antibody test
Patients who test positive for HBV or HCV
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive)
Has active co-infection with both HBV and hepatitis C virus (HCV) (detectable HCV ribonucleic acid [RNA] plus positive HBV surface antigen or HBV DNA)
Patients must be screened for hepatitis B virus (HBV); patients who are either hepatitis B surface antigen (HBsAg) positive or HBV-DNA positive must be willing and able to take antiviral therapy - weeks prior to st dose of study treatment and continue on antiviral therapy for at least weeks after the last dose of EGF; additional management of the patients would be provided by a physician with expertise in management of HBV, if needed; patients must have negative hepatitis C antibody (HCV-Ab) or positive HCV-Ab but undetectable level of HCV-ribonucleic acid (RNA); Note: patients with detectable HCV-RNA are not eligible for the study
hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test is positive);
Positive test for hepatitis B virus (HBV) using HBV surface antigen (HBVsAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection. If hepatitis C antibody test is positive then active infection has to be confirmed by hepatitis C RNA testing for the patient to be excluded.
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
Liver disease: Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation: HBV DNA and HCV RNA must be undetectable. Subjects cannot be positive for hepatitis B surface antigen or anti-hepatitis B core antibody.
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid (RNA) if anti-HCV antibody screening test positive).
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Known history of positive test for hepatitis B virus (HBV) using HBV surface antigen (HBV sAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection.
Known history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or detectable HCV RNA if anti-HCV antibody screening test positive)
Significant acute or chronic infections including, among others:\r\n* Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\r\n* Positive test for hepatitis B virus (HBV) surface antigen and / or confirmatory hepatitis C virus (HCV) ribonucleic acid (RNA) (if anti-HCV antibody tested positive)
DONOR: Sero-positive for HIV- & antibody, HTLV-I & II antibody, hepatitis B virus (HBV) and HCV
Active infection requiring systemic therapy or significant acute or chronic infections including, among others:\r\n* Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive)\r\n* Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
Significant acute or chronic infections including, among others:\r\n* Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\r\n* Positive test for hepatitis B virus (HBV) surface antigen and/or confirmatory hepatitis C virus (HCV) ribonucleic acid (RNA) (if anti-HCV antibody tested positive)
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive)
Significant acute or chronic infections including, among others:\r\n* Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\r\n* Known history of testing positive for hepatitis B virus (HBV) surface antigen and/or confirmatory hepatitis C virus (HCV) ribonucleic acid (RNA) (if anti-HCV antibody tested positive)
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive)
Known human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or at risk for HBV reactivation; HBV deoxyribonucleic acid (DNA) and testing for HCV ribonucleic acid (RNA) must be undetectable; at risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive
Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen)
Concurrent uncontrolled illness not related to cancer, including but not limited to: Ongoing or active infection, including human immunodeficiency virus (HIV), hepatitis B (HBV) (hepatitis B surface antigen [HBsAg] positive; subjects with documented laboratory evidence of HBV clearance may be enrolled) or hepatitis C (HCV) (positive HCV antibody), or bleeding
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); positive test for hepatitis B virus (HBV) using HBV surface antigen (HBV sAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test is positive);
Positive for hepatitis C virus (HCV) antibody at screening
Positive test for hepatitis B virus (HBV) using HBV surface antigen (HBVsAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection\r\n* Individuals with a positive test for HCV antibody but no detection of HCV RNA indicating no current infection are eligible
DOSE ESCALATION COHORT: Hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or at risk for HBV reactivation; hepatitis B virus deoxyribonucleic acid (DNA) and testing for HCV ribonucleic acid (RNA) must be undetectable; at risk for HBV reactivation is defined as hepatitis B surface antigen positive
DOSE EXPANSION COHORT: Hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or at risk for HBV reactivation; hepatitis B virus DNA and testing for HCV RNA must be undetectable; at risk for HBV reactivation is defined as hepatitis B surface antigen positive
Active hepatitis B virus (HBV; hepatitis B surface antigen [HepBsAG] positive [+ve] and IgM anti-hepatitis B virus core antibody [HBc]), or hepatitis C virus (HCV; detectable HCV ribonucleic acid [RNA]) infection; patients with chronic or cleared HBV and HCV infection are eligible
Known chronic infections with human immunodeficiency virus (HIV), hepatitis B (HBV) or C (HCV); hepatitis B virus DNA and testing for HCV ribonucleic acid (RNA) must be undetectable
Patients who are hepatitis C virus (HCV) antibody positive and HCV ribonucleic acid (RNA) or hepatitis B virus (HBV) surface antigen positive and HBV DNA positive
Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen)
Presence of hepatitis C antibody test (anti-hepatitis C virus [HCV])
Documentation of hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies is required: this includes hepatitis B surface antigen (HBsAg) and/or total hepatitis B core antibody (HBcAb) in addition to HCV antibody testing; the most recent serologic testing must have occurred within weeks prior to registration; if such testing has not been done, it must be performed during screening\r\n* Note: patients who have positive HBV (i.e., HBsAg or HBcAb) or HCV serologies without known active disease must meet the eligibility criteria for ALT, AST, total bilirubin (TBILI), INR, activated partial thromboplastin time (aPTT)/PTT, and alkaline phosphatase (ALP) on at least two consecutive occasions, separated by at least week, within the -day screening period; the second of these evaluations must be performed within days prior to the first treatment administration
Hepatitis C virus (HCV) antibody positive
Part A: Known history of testing positive for HIV or known acquired immunodeficiency syndrome (AIDS) or any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection. For Part B, known history of testing positive for HIV or known AIDS in consultation with the Medical Monitor or HBV or HCV infection at screening (positive HBV surface antigen or HCV RNA if anti- HCV antibody screening test positive).
Patient has acute viral hepatitis (typically defined by elevated AST/ALT), or a history of chronic or active hepatitis B virus (HBV) or hepatitis c virus (HCV) infection; HBV infection is defined as having hepatitis B surface antigen (HBsAg) and/or hepatitis B virus core antibody (HBcAb) positive test with concurrent detectable HBV deoxyribonucleic acid (DNA) levels; HCV infection is defined as detectable HCV ribonucleic acid (RNA) levels
Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen)
Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen)
Arms A, C and D: Patient has acute viral hepatitis or a history of chronic or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, (typically defined by elevated AST/ALT (persistent or intermittent), high HBV deoxyribonucleic acid [DNA] level, HBsAg positive, or high HCV ribonucleic acid [RNA] level [testing not mandatory])
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
Positive test for hepatitis B virus (HBV) surface antigen and/or confirmatory hepatitis C virus (HCV) RNA (if anti-HCV antibody tested positive).
Positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) ribonucleic acid (RNA) (or HCV antibody)
Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen).
Hepatitis C virus (HCV) antibody positive
Positive test results for chronic hepatitis B virus (HBV) infection or for hepatitis C virus (HCV) antibody
Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen)
Has known active hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)\r\n* Note: the following will not be exclusionary:\r\n** A positive hepatitis B serology indicative of previous immunization (i.e., HBsAb positive and hepatitis B virus core antibody [HBcAb] negative), or a fully resolved acute hepatitis B virus (HBV) infection \r\n** Patients with chronic HBV suppressed by appropriate antiretroviral therapy with activity against HBV, as outlined in Department of Health and Human Services (DHHS) guidelines\r\n** Positive HCV serology but no detectable HCV RNA, indicative of spontaneously cleared HCV infection\r\n** Patients who have been successfully treated for HCV as long as therapy for HCV has been completed
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive)
Significant acute or chronic infections as these may affect the immune response including:\r\n* Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\r\n* Positive test for hepatitis B virus (HBV) surface antigen and / or confirmatory hepatitis C virus (HCV) ribonucleic acid (RNA) (if anti-HCV antibody tested positive)