Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C, Chronic

Treatments: Drug: Cross-Over Boceprevir Treatment; Drug: Boceprevir (BOC); Drug: Ribavirin (RBV); Drug: Peginterferon alfa-2b (PEG); Drug: Placebo to boceprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01390844

P07063

3034-033 (Other Identifier)

CTRI/2012/04/002540 (Registry Identifier)

2007-005151-42

Details and patient eligibility

About

This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia Pacific population. The primary hypothesis is that the proportion of participants achieving sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.

Enrollment: 282 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously documented CHC genotype 1 infection. Other or mixed genotypes are not eligible.
• Liver biopsy with histology consistent with CHC and no other etiology.
• Participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma
• Failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus RBV
• Weight between 40 kg and 125 kg, inclusive
• Of 'local' ancestral descent
• Sexually active males and females of child-bearing potential must agree to use a medically accepted method of contraception

Exclusion criteria

• Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus.
• Required discontinuation of previous interferon or RBV regimen for an adverse event considered to be possibly or probably related to RBV and/or interferon.
• Treatment with RBV within 90 days and any interferon-alpha within 1 month prior to screening.
• Treatment for hepatitis C with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity.
• Treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit.
• Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
• Diabetes and/or hypertension with clinically significant ocular examination findings.
• Any condition the could interfere with participation in and completion of the trial.
• Evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin).
• Pregnant or breast-feeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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282 participants in 2 patient groups

Boceprevir

Experimental group

Description:

PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.

Treatment:

Drug: Peginterferon alfa-2b (PEG)

Drug: Placebo to boceprevir

Drug: Ribavirin (RBV)

Drug: Boceprevir (BOC)

Control

Active Comparator group

Description:

PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.

Treatment:

Drug: Peginterferon alfa-2b (PEG)

Drug: Placebo to boceprevir

Drug: Ribavirin (RBV)

Drug: Cross-Over Boceprevir Treatment