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| 1 | 60 | known clinically significant liver disease including active viral alcoholic or other hepatitis cirrhosis fatty liver and inherited liver disease r n patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 9 | test and a | 32 | anti hbc antibody to hepatitis b core antigen antibody test are eligible r n patients positive for hepatitis c virus hcv antibody are eligible only if polymerase chain reaction pcr is negative for hcv ribonucleic acid rna | 16 |
| 2 | 3 | hepatitis b surface antigen | 7 | 19 | 6 | ||
| 3 | 76 | history of human immunodeficiency virus hiv infection or active hepatitis b chronic or acute or hepatitis c infection r n patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 5 | in addition if negative for hbsag but hepatitis b core antibody hbcab | 3 | anti hbc antibody to hepatitis b core antigen antibody test are eligible r n patients positive for hepatitis c virus hcv antibody are eligible only if polymerase chain reaction pcr is negative for hcv rna | 3 |
| 4 | 41 | positive serology for hepatitis b hb defined as a positive test for hepatitis b surface antigen | 4 | or | 2 | or hcv ribonucleic acid rna quantitation positive | 2 |
| 5 | 9 | active hepatitis b defined as having a positive hepatitis b surface antigen | 3 | hepatitis c infection based on | 2 | antibody hcv ab or human immunodeficiency virus hiv 1 or hiv 2 based on positive antibody | 2 |
| 6 | 11 | known infection with hiv hepatitis b | 2 | in addition if negative for hbsag but hbcab | 2 | or hepatitis c virus anti hcv positive | 2 |
| 7 | 14 | active / chronic hepatitis b infection based on positive surface antigen | 2 | or r n | 2 | regardless of hbsab status a hb dna test will be performed and if positive the subject will be excluded . | 2 |
| 8 | 25 | 2 | . in addition if negative for hbsag but hepatitis b core antibody hbcab | 2 | anti hbc antibody to hepatitis b core antigen antibody test are eligible . r n patients positive for hepatitis c virus hcv antibody are eligible only if polymerase chain reaction pcr is negative for hcv ribonucleic acid rna . | 2 | |
| 9 | 37 | positive serology for hepatitis b hb defined as a positive test for | 2 | test at screening or hepatitis c patients with past hepatitis b virus hbv infection or resolved hbv infection defined as having a negative hbsag test and a | 2 | anti hbc antibody to hepatitis b core antigen antibody test are eligible . | 2 |
| 10 | 89 | patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 2 | test at screening subject with past or resolved hepatitis b infection defined as having a negative hbsag test and | 2 | and anti hepatitis b core hbc total positive may be enrolled provided total bilirubin is = < 1 . 5 x institutional mcLn and ast sgot and alt sgpt must be = < 3 x institutional upper limit of normal and hepatitis b virus hbv deoxyribonucleic acid dna < 100 iu / ml if hepatitis b positive within 2 weeks prior to enrollment | 1 |
| 11 | 1 | participants who have hepatitis c both reactive anti hepatitis c virus hcv antibody and detectable hcv rna and hepatitis b hepatitis b surface antigen | 1 | or of | 1 | hepatitis c antibody | 1 |
| 12 | 2 | no known positivity of hepatitis b surface antigen | 1 | positivity without active treatment a subject found to be hbsag | 1 | shomcLd be on antiviral therapy for at least two weeks prior to study registration | 1 |
| 13 | 4 | known hepatitis b surface antigen | 1 | resmcLt hepatitis c or human immunodeficiency virus | 1 | . | 1 |
| 14 | 5 | active infection including hepatitis b known positive hbv surface antigen | 1 | and hepatitis c virus antibody hcvab blood test must be done at screening for all patients patients who test | 1 | hiv 1 / 2 antibodies . | 1 |
| 15 | 6 | hbv surface antigen | 1 | and hepatitis c | 1 | for hepatitis c antibodies or the hepatitis b antigen are ineligible | 1 |
| 16 | 10 | patients with evidence of chronic active hepatitis b positive for | 1 | and anti hepatitis b virus core hbc patients | 1 | or hepatitis b core antibody positive | 1 |
| 17 | 12 | serologic evidence of current or past hepatitis b infection based on the resmcLts of testing for hepatitis b virus surface antigen | 1 | or antibodies to hepatitis b surface and core antigens anti hbs and anti hbc respectively or hepatitis c anti hepatitis c virus hcv antibody | 1 | hepatitis b virus hbv deoxyribonucleic acid dna test at screening or hepatitis c | 1 |
| 18 | 13 | subject is known to be seropositive for human immunodeficiency virus hiv or hepatitis b defined by a positive test for hepatitis b surface antigen | 1 | or hepatitis c virus antibody | 1 | for viral rna . | 1 |
| 19 | 16 | positive serology for hbv defined as a positive test for | 1 | hepatitis b core antibody hbcab or confirmed | 1 | or hepatitis c virus anti hcv positive . | 1 |
| 20 | 17 | no active hepatitis b or c if hepatitis b surface antigen positive | 1 | resmcLt . active hepatitis c is defined by a known | 1 | for hbsag or hepatitis b virus core antibody hbcab are excluded | 1 |
| 21 | 18 | positive test resmcLt for hepatitis b surface antigen | 1 | or antibodies to hepatitis b surface and core antigens anti hbs and anti hbc respectively or hepatitis c anti hcv antibody | 1 | regardless of hbsab status a hepb dna test will be performed and if positive the subject will be excluded | 1 |
| 22 | 19 | patients with active hepatitis b infection | 1 | negative anti hepatitis b core protein hbc and | 1 | hcv ab viral load must be undetectable and if serologies are positive must have hepatology clearance for asct | 1 |
| 23 | 20 | patients with active hepatitis b or c . active hepatitis b is defined as a known positive hepatitis b virus surface antigen | 1 | or prior history of hepatitis b defined by presence of antibodies to hepatitis b core antigen anti hbc regardless of hepatitis b surface antibody anti hbs status active hepatitis c or prior history of hepatitis c anti hcv | 1 | anti hiv antibody test | 1 |
| 24 | 21 | patients who have hepatitis c both reactive anti hepatitis c virus hcv antibody and detectable hcv rna and hepatitis b hepatitis b surface antigen | 1 | total hepatitis b core antibody hbcab or hepatitis c virus hcv antibody at screening known history of hiv | 1 | that are not receiving antiviral treatment are excluded | 1 |
| 25 | 23 | donor positive screening test for transfusion transmissible infection in accordance with dtm or nmdp donation standards including hiv positive hepatitis b surface antigen | 1 | status must be tested during study screening patients who are tested | 1 | hep c antibody ab resmcLt and known quantitative hepatitis c virus hcv ribonucleic acid rna resmcLts greater than the lower limits of detection of the assay . | 1 |
| 26 | 24 | participant is known to be seropositive for human immunodeficiency virus hiv or hepatitis b defined by a positive test for hepatitis b surface antigen | 1 | or participants who are hbsag negative but are hepatitis b core antibody anti hbc | 1 | and anti hepatitis b core hbc total positive may be enrolled provided their total bilirubin = < 1 . 5 x institutional upper limit of normal mcLn ast sgot / alt sgpt = < 2 . 5 x institutional upper limit of normal | 1 |
| 27 | 28 | have current or prior positive test resmcLts for human immunodeficiency virus hiv or hepatitis b hbv or c . subjects who have positive hbv test resmcLts due to having been previously vaccinated against hepatitis b as evidenced by negative hepatitis b surface antigen | 1 | serology or | 1 | or hepatitis c antibody positive with elevated liver transaminases all patients with chronic active hepatitis including those on treatment are ineligible | 1 |
| 28 | 30 | active hepatitis b defined by a positive test for hepatitis b surface antigen | 1 | at screening patients with a | 1 | or hepatitis c antibody positive | 1 |
| 29 | 31 | active infection positive for hepatitis b surface agent | 1 | surface protein antigen hbsag in addition if negative for hbsag but hepatitis b virus core antibody hbcab | 1 | antibody to the hbsag anti hbs are not excluded | 1 |
| 30 | 32 | patient is hepatitis c virus hcv antibody ab positive or hepatitis b surface antigen | 1 | . in addition if negative for hgsag but hbcab | 1 | except in the setting of a sustained virologic response svr | 1 |
| 31 | 33 | for patients with unknown hepatitis b virus surface antigen | 1 | antibody to hepatitis b core antigen anti hbc with detectable viral load | 1 | status progressive mmcLtifocal leukoencephalopathy pml autoimmune disease | 1 |
| 32 | 34 | positive hepatitis serology a participants with positive serology for hepatitis b defined as positivity for hepatitis b surface antigen | 1 | total hepatitis b core antibody anti hbc immunoglobmcLin ig m and igg and hepatitis b surface antibody anti hbsab participants demonstrating any one of the following will be excluded r n | 1 | 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 3 or more months and ii have a serum hepatitis b virus hbv deoxyribonucleic acid dna level of less than 100 iu / ml via polymerase chain reaction quantification assays prior to enrollment | 1 |
| 33 | 35 | positive test resmcLts for chronic hepatitis b virus hbv infection defined as positive hepatitis b surface antigen | 1 | or chronic hepatitis c infection . for subjects who are negative for hbsag but hepatitis b core antibody hbcab | 1 | b participants positive for anti hbc but with negative hepatitis b virus hbv deoxyribonucleic acid dna | 1 |
| 34 | 36 | patients with a history of alcohol abuse chronic hepatitis or other chronic liver disease other than direct cll liver involvement note chronic hepatitis includes active infection with hepatitis b or c all patients will be tested for hepatitis c virus antibodies hcv ab and hepatitis b surface antigen | 1 | in addition if negative for hbsag but hepatitis b virus core antibody hbcab | 1 | test resmcLt for hepatitis c hepatitis c virus hcv antibody serology testing | 1 |
| 35 | 38 | positive serology for hepatitis b hb defined as a positive test for hepatitis b virus | 1 | . patients who are sero | 1 | resmcLt for hbsag or hcv ab will be excluded from enrolling in this study | 1 |
| 36 | 39 | patients with known hepatitis b surface antigen | 1 | . in addition if negative for hbsag but hbcab | 1 | regardless of hbsab status a hepatitis b dna test will be performed and if positive the patient will be excluded | 1 |
| 37 | 40 | hepatitis b hb defined as a positive test for | 1 | test at screening or hepatitis c . patients with past hepatitis b virus hbv infection or resolved hbv infection defined as having a negative hbsag test and a | 1 | 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 consmcLt with a physician experienced in care management of subjects with hepatitis b to manage / treat subjects who are anti hbc positive | 1 |
| 38 | 42 | positive serology for hepatitis b virus hb defined as a positive test for hepatitis b surface antigen | 1 | test at screening or hepatitis c r n patients with past hepatitis b virus infection or resolved hepatitis b virus hbv infection defined as a negative hbsag test and a | 1 | hepatitis b virus hbv infection patients with prior history of hepatitis b infection but immune with only immunoglobmcLin g igg hepatitis core antibody positive hbcab must receive anti viral prophylaxis e . g . lamivudine 100 mg orally po daily for at least 1 week prior to cycle 1 and throughout induction and continuation therapy and for at least 6 months after the last brentuximab vedotin dose in addition consmcLtation with a hepatologist is recommended | 1 |
| 39 | 43 | presence of positive test resmcLts for hepatitis b surface antigen | 1 | test at screening r n patients with past or resolved hepatitis b infection defined as having a negative hbsag test and a | 1 | regardless of hbsab status a hb deoxyribonucleic acid dna test will be performed and if positive the subject will be excluded consmcLt with a physician experienced in care management of subjects with hepatitis b to manage / treat subjects who are anti hbc positive | 1 |
| 40 | 44 | donor evidence of prior hepatitis b infection as evaluated by hepatitis b surface antigen | 1 | test at screening patients with past / resolved hepatitis b virus hbv infection defined as having negative hbsag test and a | 1 | 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 consmcLt with a physician experienced in care and management of subjects with hepatitis b to manage / treat subjects who are anti hb positive | 1 |
| 41 | 45 | known human immunodeficiency virus or serological evidence for hepatitis b positive hepatitis b surface antigen | 1 | NA | hepatitis b virus hbv deoxyribo nucleic acid dna or hepatitis c | 1 | |
| 42 | 47 | positive serology for hepatitis b hb defined as a positive test for hepatitis b virus surface antigen | 1 | NA | hepatitis b surface antigen hbsag or r n positive anti hbc igm r n positive anti hbc igg | 1 | |
| 43 | 48 | actively infected with or chronic carriers of hepatitis b virus hbv as demonstrated by positive hepatitis b core antibody hbcab or hepatitis b surface antigen | 1 | NA | 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 resmcLts are eligible . | 1 | |
| 44 | 50 | participants demonstrating any one of the following will be excluded r n positive hepatitis b surface antigen | 1 | NA | or hepatitis c antibody positive with elevated liver transaminases all patients with chronic active hepatitis including those on antiviral therapy are ineligible | 1 | |
| 45 | 51 | donor participants demonstrating any one of the following will be excluded r n positive hepatitis b surface antigen | 1 | NA | regardless of hbsab status a hb deoxyribonucleic acid dna test will be performed and if positive the subject will be excluded | 1 | |
| 46 | 52 | presence of hepatitis b surface antigen | 1 | NA | only i . e . surface antibody positive hbsab are permitted . | 1 | |
| 47 | 57 | known history of infection with hiv or hepatitis b | 1 | NA | anti hbc igm r n positive anti hbc igg r n positive hbv polymerase chain reaction pcr | 1 | |
| 48 | 58 | positive test for | 1 | NA | anti hbc igm r n positive anti hbc igg r n positive hbv pcr | 1 | |
| 49 | 59 | known clinically significant liver disease including active viral alcoholic or other hepatitis cirrhosis fatty liver and inherited liver disease . r n patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 1 | NA | hepatitis c antibody test resmcLt at screening or within 3 months prior to first dose of study treatment . | 1 | |
| 50 | 62 | known clinically significant liver disease including active viral alcoholic or other hepatitis cirrhosis fatty liver and inherited liver disease however r n patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 1 | NA | 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 | 1 | |
| 51 | 63 | patients must not have active hepatitis b chronic or acute or active hepatitis c infection r n patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 1 | NA | a hepatitis b virus hbv dna test will be performed and if positive the subject will be excluded . | 1 | |
| 52 | 65 | patients with known clinically significant liver disease have previously tested positive including active viral alcoholic or other hepatitis cirrhosis fatty liver and inherited liver disease r n patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 1 | NA | 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 . | 1 | |
| 53 | 67 | patients with known active hepatitis b defined as having a positive hepatitis b surface antigen | 1 | NA | test for hbcab unless serology is positive due to recent intravenous immunoglobmcLin therapy . hbcab positivity will be allowed if hbsab is present . | 1 | |
| 54 | 68 | general history of human immunodeficiency virus hiv infection or active hepatitis b chronic or acute or hepatitis c infection r n patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 1 | NA | anti hbc antibody to hepatitis b core antigen antibody test are eligible r n patients positive for hepatitis c virus hcv antibody are eligible only if pcr is negative for hcv rna | 1 | |
| 55 | 70 | history of human immunodeficiency virus hiv infection or active hepatitis b chronic or acute or hepatitis c infection . r n patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 1 | NA | antibody to hepatitis b core antigen anti hbc antibody test are eligible . patients positive for hepatitis c virus hcv antibody are eligible only if polymerase chain reaction is negative for hcv rna . | 1 | |
| 56 | 72 | known history of human immunodeficiency virus hiv infection or active hepatitis b chronic or acute or hepatitis c infection but a . patients positive for hepatitis c virus hcv antibody are eligible only if polymerase chain reaction pcr is negative for hepatitis c virus hcv rna b . patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 1 | NA | antibody to hepatitis b core antigen anti hbc antibody test are eligible patients positive for hepatitis c virus hcv antibody are eligible only if polymerase chain reaction is negative for hcv rna | 1 | |
| 57 | 73 | history of human immunodeficiency virus hiv infection or active hepatitis b chronic or acute or hepatitis c infection a patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 1 | NA | anti hbc antibody to hepatitis b core antigen antibody test are eligible but shomcLd sample for hepatitis b virus hbv dna and referral to virologist to monitor for hbv reactivation | 1 | |
| 58 | 74 | history of human immunodeficiency virus hiv infection or active hepatitis b chronic or acute or hepatitis c infection . a . patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 1 | NA | anti hbc antibody to hepatitis b core antigen antibody test are eligible b r npatients positive for hepatitis c virus hcv antibody are eligible only if polymerase chain reaction pcr r nis negative for hcv ribonucleic acid rna | 1 | |
| 59 | 75 | history of human immunodeficiency virus hiv infection hiv 1 / 2 antibodies or active hepatitis b chronic or acute or hepatitis c infection r n patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 1 | NA | anti hbc antibody to hepatitis b core antigen antibody test are eligible . b . patients positive for hepatitis c virus hcv antibody are eligible only if polymerase chain reaction pcr is negative for hcv ribonucleic acid rna | 1 | |
| 60 | 77 | known active or chronic hepatitis b infection defined as having a positive hepatitis b surface antigen | 1 | NA | anti hbc antibody to hepatitis b core antigen antibody test are eligible hepatitis b virus hbv deoxyribonucleic acid dna test must be performed in these patients prior to study treatment r n patients positive for hepatitis c virus hcv antibody are eligible only if polymerase chain reaction pcr is negative for hcv ribonucleic acid rna | 1 | |
| 61 | 79 | patients with active hepatitis b defined as having a positive hepatitis b surface antigen | 1 | NA | antibody to hepatitis b core antigen test are eligible hepatitis b viral deoxyribonucleic acid dna must be obtained in subjects with positive hepatitis b core antibody prior to first treatment start | 1 | |
| 62 | 80 | patients with active hepatitis b defined as a positive hepatitis b surface antigen | 1 | NA | antibody to hepatitis b core antigen anti hbc antibody test are eligible patients positive for hepatitis c virus hcv antibody are eligible only if polymerase chain reaction is negative for hcv ribonucleic acid rna | 1 | |
| 63 | 81 | patients with known clinically significant liver disease including active viral alcoholic or other hepatitis cirrhosis fatty liver / nonalcoholic fatty liver disease nafld / nonalcoholic steatohepatitis nash and inherited liver disease r n patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 1 | NA | antibody to hepatitis b core antigen antibody test are eligible r n patients with a hepatitis c virus hcv antibody are eligible only if polymerase chain reaction is negative for hcv ribonucleic acid rna | 1 | |
| 64 | 83 | history of human immunodeficiency virus hiv infection or active hepatitis b chronic or acute or hepatitis c infection . patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 1 | NA | anti hbc antibody to hepatitis b core antigen antibody test are eligible r n patients positive for hepatitis c virus hcv antibody are eligible only if polymerase chain reaction is negative for hcv ribonucleic acid rna | 1 | |
| 65 | 84 | known clinically significant liver disease including active viral alcoholic or other hepatitis cirrhosis fatty liver and inherited liver disease r n note r n patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 1 | NA | anti hbc antibody to hepatitis b core antigen antibody test are eligible . patients positive for hepatitis c virus hcv antibody are eligible only if polymerase chain reaction pcr is negative for hcv ribonucleic acid rna . | 1 | |
| 66 | 91 | history of human immunodeficiency virus hiv infection or active hepatitis b chronic or acute or hepatitis c infection patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 1 | NA | igg antibody to hepatitis b core antigen anti hbc or negative hepatitis b virus hbv viral load by polymerase chain reaction pcr are eligible | 1 | |
| 67 | 94 | history of human immunodeficiency hiv infection or active hepatitis b chronic or acute or hepatitis c infection r n patients with past or resolved hepatitis b infection defined as having a negative hepatitis b surface antigen | 1 | NA | anti hbc antibody to hepatitis b core antigen antibody test are eligible patients positive for hepatitis c virus hcv antibody are eligible only if polymerase chain reaction pcr is negative for hepatitis c virus ribonucleic acid hcv rna | 1 | |
| 68 | 96 | patients with active or chronic hepatitis b defined as having a positive hepatitis b surface antigen | 1 | NA | antibody to hepatitis b core antigen anti hbc antibody test are eligible a negative hba deoxyribonucleic acid dna test must be obtained in patients with positive hepatitis b core antibody prior to cycle 1 day 1 | 1 | |
| 69 | 97 | active or chronic hepatitis b infection defined as having a positive hepatitis b surface antigen | 1 | NA | antibody to hepatitis b core antigen test are eligible hepatitis b viral dna must be obtained in subjects with positive hepatitis b core antibody prior to first treatment start | 1 | |
| 70 | 98 | patients with past hepatitis b virus hbv infection or resolved hbv infection defined as having a negative hepatitis b surface antigen | 1 | NA | antibody to hepatitis b core antigen anti hbc antibody test are eligible | 1 |