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

NCT ID: NCT01390844

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-21
• Study Completion Date: 2015-06-19

Brief Summary

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.

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Boceprevir

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.

Group Type: EXPERIMENTAL

Boceprevir (BOC)

Intervention Type: DRUG

200 mg capsules, 800 mg three times daily by mouth

Placebo to boceprevir

Intervention Type: DRUG

200 mg placebo capsules, 800 mg three times daily by mouth

Peginterferon alfa-2b (PEG)

Intervention Type: DRUG

1.5 mcg/kg/week subcutaneously

Ribavirin (RBV)

Intervention Type: DRUG

200 mg capsules, weight-based dosing 800 to 1400 mg/day by mouth divided twice daily

Control

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.

Group Type: ACTIVE_COMPARATOR

Placebo to boceprevir

Intervention Type: DRUG

200 mg placebo capsules, 800 mg three times daily by mouth

Peginterferon alfa-2b (PEG)

Intervention Type: DRUG

1.5 mcg/kg/week subcutaneously

Ribavirin (RBV)

Intervention Type: DRUG

200 mg capsules, weight-based dosing 800 to 1400 mg/day by mouth divided twice daily

Cross-Over Boceprevir Treatment

Intervention Type: DRUG

At Treatment Week 14, participants in the Placebo group with detectable HCV-RNA at Treatment Week 12 have the option to add boceprevir 800 mg three times daily to the PEG + RBV regimen for up to 32 weeks.

Interventions

Boceprevir (BOC)

200 mg capsules, 800 mg three times daily by mouth

Intervention Type: DRUG

Placebo to boceprevir

200 mg placebo capsules, 800 mg three times daily by mouth

Intervention Type: DRUG

Peginterferon alfa-2b (PEG)

1.5 mcg/kg/week subcutaneously

Intervention Type: DRUG

Ribavirin (RBV)

200 mg capsules, weight-based dosing 800 to 1400 mg/day by mouth divided twice daily

Intervention Type: DRUG

Cross-Over Boceprevir Treatment

At Treatment Week 14, participants in the Placebo group with detectable HCV-RNA at Treatment Week 12 have the option to add boceprevir 800 mg three times daily to the PEG + RBV regimen for up to 32 weeks.

Intervention Type: DRUG

Other Intervention Names

SCH 503034; Victrelis; PegIntron; SCH 054031; Redipen; Rebetol; SCH 018908; SCH 503034; Victrelis

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2007-005151-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3034-033

Identifier Type: OTHER

Identifier Source: secondary_id

CTRI/2012/04/002540

Identifier Type: REGISTRY

Identifier Source: secondary_id

P07063

Identifier Type: -

Identifier Source: org_study_id