Clinical trial NCT01390844: Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)
Official title: Safety and Efficacy of Boceprevir in Combination With Peginterferon Plus Ribavirin for Treatment of Asia Pacific Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Pegylated Interferon Plus Ribavirin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-07-11
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population
timeFrame: Follow-up Week 24
measure: Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population
timeFrame: Follow-up Week 24
Secondary outcomes:
measure: Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population
timeFrame: Follow-up Week 24
measure: Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population
timeFrame: Follow-up Week 24
measure: Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8
timeFrame: Treatment Week 8
measure: Percentage of Participants in India Achieving EVR at Treatment Week 8
timeFrame: Treatment Week 8
measure: Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan
timeFrame: Up to 96 weeks
measure: Percentage of Participants With an AE of Anemia in India
timeFrame: Up to 96 weeks
measure: Percentage of Participants With an AE of Neutropenia in Korea and Taiwan
timeFrame: Up to 96 weeks
measure: Percentage of Participants With an AE of Neutropenia in India
timeFrame: Up to 96 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: