A Phase 3 Safety and Efficacy Study of Boceprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin - ND

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 198

Inclusion Criteria

Subjects with CHC (genotype 1) who failed to achieve SVR on prior adequate treatment with any peginterferon alfa and ribavirin but demonstrated interferon responsiveness (a decrease in HCV-RNA viral load ≥2 log10 by TW 12 or undetectable HCV-RNA at End of Treatment [EOT]) will be selected for the study. Inclusion Criteria for Interferon-Responsive CHC Patients Who Have Failed Treatment: 1. For inclusion in the study, subjects must have a qualifying regimen defined as PEG2a/R or PEG2b/R for a minimum of 12 weeks. If a subject has received more than one such regimen, the most recent regimen is considered the qualifying regimen. Note: Maintenance therapy, following failure of qualifying therapy, with any interferon alfa is acceptable; however, the subject must have discontinued the maintenance therapy at least 1 month prior to the Screening Visit. 2. During the qualifying regimen, subjects must have either: a. A documented undetectable HCV-RNA within 30 days of EOT and a subsequent detectable HCVRNA during follow-up OR b. A documented decline in HCV-RNA by ≥2 log10 by TW 12. Note: For subjects who did not participate in Schering-Plough Research Institute (SPRI) protocols, qualifying virology reports and documentation of qualifying previous treatment regimen must be completely deidentified and faxed to the sponsor`s project physician for confirmation that the documentation meets protocol-specified criteria. 3. Subject must have previously documented CHC genotype 1 infection. Subjects with other or mixed genotypes are not eligible. The HCV-RNA result obtained from the central laboratory at the Screening Visit must confirm genotype 1 infection and be ≥10,000 IU/mL. 4. Subject must have a liver biopsy with histology consistent with CHC and no other etiology. Copies of the pathology report and slides are required for the subject to be included in the study. The study site must be able to access the pathology report and histology slides prior to subject randomization. Two unstained slides are preferred; however, one slide stained with hematoxylin plus eosin (H & E) plus one slide stained with Masson?s trichrome will be accepted (slides should be reviewed by the investigator to confirm adequacy). The central pathologist?s reading will be used for analysis purposes. a. If no cirrhosis is present: The liver biopsy must be within 3 years of the Screening Visit. b. If cirrhosis is present: Any historic liver biopsy demonstrating cirrhosis will be accepted regardless of length of time since biopsy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subjects known to be coinfected with the human immunodeficiency virus (HIV) or hepatitis B virus (hepatitis B surface antigen [HBsAg] positive) and/or demonstrating signs and symptoms consistent with co-infection. 2. Subjects who required discontinuation of previous interferon or ribavirin regimen for an adverse event considered by the investigator to be possibly or probably related to ribavirin and/or interferon. 3. Treatment with ribavirin within 90 days and any interferon alfa within 1 month of Screening. 4. Treatment for hepatitis C with any investigational medication. Prior treatment with herbal remedies with known hepatotoxicity is exclusionary. All herbal remedies used for hepatitis C treatment other than silymarin (milk thistle) must be discontinued before Day 1. 5. Treatment with any investigational drug within 30 days of the randomization visit in this study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method