The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C Genotype 1

Treatments: Drug: Boceprevir; Drug: Placebo; Biological: peginterferon alfa-2b; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01425203

MK-3034-046 (Other Identifier)

P08160

Details and patient eligibility

About

The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) [PEG+RBV=PR] is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The primary hypothesis is that the percentage of participants achieving sustained virologic response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.

Enrollment: 238 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• body weight ≥40 kg and ≤125 kg
• previously documented CHC genotype 1 infection;
• must have a liver biopsy with histology consistent with CHC and no other etiology
• if cirrhosis present, must have an ultrasound within 6 months of the screening visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC)
• agree to use acceptable methods of contraception with partner
• previously untreated with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV or failing prior treatment with pegylated-interferon (either alfa-2a or alfa-2b) plus RBV

Exclusion criteria

• co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen [HBsAg] positive).
• required discontinuation of previous interferon or ribavirin regimen for an adverse event (possibly or probably related)
• treatment with ribavirin within 90 days and any interferon-alpha, based on the amendment, should be within 1 month prior to screening
• treatment with any investigational drug within 30 days of the screening visit in this trial
• evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
• diabetic and/or hypertensive with clinically significant ocular examination findings
• clinical diagnosis of substance abuse of specified drugs within specified timeframes
• any known pre-existing medical condition that could interfere with the participant's participation in and completion of the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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238 participants in 3 patient groups, including a placebo group

RGT BOC + PR

Experimental group

Description:

Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.

Treatment:

Drug: Ribavirin

Biological: peginterferon alfa-2b

Drug: Boceprevir

PBO + PR (Control)

Placebo Comparator group

Description:

Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.

Treatment:

Drug: Ribavirin

Drug: Placebo

Biological: peginterferon alfa-2b

Crossover Arm

Experimental group

Description:

Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR.

Treatment:

Drug: Ribavirin

Biological: peginterferon alfa-2b

Drug: Boceprevir