Status:
COMPLETED
Boceprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05685AM2)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Based on previous experience with peginterferon alfa-2b/ribavirin in combination with boceprevir, the combination with peginterferon alfa- 2a/ribavirin and boceprevir is expected to be safe and well ...
Eligibility Criteria
Inclusion
- Subjects must have a qualifying regimen defined as peginterferon alfa-2a/ribavirin or peginterferon alfa-2b/ribavirin for a minimum of 12 weeks.
- During the qualifying regimen, subjects must have either:
- A documented undetectable Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) within 30 days of the end-of-treatment and a subsequent detectable HCV-RNA during follow-up OR
- A documented decline in HCV-RNA by \>=2 log10 after 12 weeks of treatment.
- Subject must have previously documented chronic hepatitis C genotype 1 infection.
- Subject must have a liver biopsy with histology consistent with chronic hepatitis C infection and no other etiology.
- Subjects with bridging fibrosis or cirrhosis must have an ultrasound within 6 months with no findings suspicious for hepatocellular carcinoma (HCC).
- Subject must be \>=18 years of age.
- Subject must weigh between 40 kg and 125 kg.
- Subject and subject's partner(s) must each agree to use acceptable methods of contraception.
- Subjects must be willing to give written informed consent.
Exclusion
- Subject will be excluded from entry if ANY of the criteria listed below are
- met:
- 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.
- 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.
- Treatment with ribavirin within 90 days and any interferon alfa within 1 month of Screening.
- Treatment for hepatitis C with any investigational medication. Prior treatment with herbal remedies with known hepatotoxicity is exclusionary.
- Treatment with any investigational drug within 30 days of the randomization visit in this study.
- Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study.
- Evidence of decompensated liver disease.
- Diabetic and/or hypertensive subjects with clinically significant ocular examination findings.
- Pre-existing psychiatric condition(s).
- Clinical diagnosis of substance abuse.
- Any known pre-existing medical condition that could interfere with the subject's participation in and completion of the study.
- Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin).
- Subjects who are pregnant or nursing. Subjects who intend to become pregnant during the study period. Male subjects with partners who are or who intend to become pregnant during the study period.
- Any other condition which, in the opinion of a physician, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study.
- Subjects who are part of the site personnel directly involved with this study.
- Subjects who are family members of the investigational study staff.
- Subjects who had a life-threatening serious adverse event (SAE) during the screening period.
- Subjects with a history of pancreatitis, except for one episode clearly secondary to gallstone.
- Laboratory
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT00845065
Start Date
February 1 2009
End Date
October 1 2010
Last Update
April 7 2017
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