A Study to Evaluate the Efficacy and Safety of Boceprevir Added to Standard of Care Therapy in Previously Treated Participants With Chronic Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105)

NCT ID: NCT01756079

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-06
• Study Completion Date: 2015-11-17

Brief Summary

This study is being done to find out if the addition of boceprevir to standard of care (SOC) treatment with peginterferon alfa-2b (PegIFN-2b) + ribavirin (RBV) is effective for participants with chronic hepatitis C (CHC) genotype 1 and cirrhosis who were not successfully treated by previous SOC. All participants will receive treatment with SOC alone for 4 weeks and then boceprevir will be added to the treatment regimen for 44 additional weeks of combined treatment.

Conditions

Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PegIFN-2b + RBV+ boceprevir

Participants will receive PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks and then will receive 44 additional weeks of treatment with PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day).

Group Type: EXPERIMENTAL

boceprevir

Intervention Type: DRUG

PegIFN-2b

Intervention Type: BIOLOGICAL

RBV

Intervention Type: DRUG

Interventions

boceprevir

Intervention Type: DRUG

PegIFN-2b

Intervention Type: BIOLOGICAL

RBV

Intervention Type: DRUG

Other Intervention Names

SCH 503034; Peginterferon alfa-2b; PegIntron; SCH 054031; Ribavirin; Rebetol

Eligibility Criteria

Inclusion Criteria

• Weight between 40 kg and 125 kg
• Documented CHC genotype 1 infection
• Previous course of treatment with SOC (PegIFN-2a or PegIFN-2b + RBV) with a documented non-response
• Documented diagnosis of cirrhosis
• No evidence of hepatocellular carcinoma (HCC) by ultrasound
• Participant and partner of participant must agree to use 2 effective contraceptives as specified for at least 2 weeks prior to Day 1 of treatment and continue until at least 6 months after last dose of study drug (7 months for male participants)

Exclusion Criteria

• Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus
• Use of any investigational drugs within 30 days prior to study enrollment
• Participation in any other clinical trial within 30 days of study enrollment or intention to participate in another clinical trial during this study
• Evidence of present or previous decompensated liver disease including, but not limited to, a history or presence of clinical ascites or hepatic encephalopathy. Only participants with large (F3) esophageal varices, as determined in an esophagogastroduodenoscopy (EGD) performed within the past 12 months according to international guidelines will be excluded.
• Clinically significant ocular examination findings
• Pre-existing significant psychiatric condition(s)
• Clinical diagnosis of active or recent substance abuse
• Evidence of active or suspected malignancy, or a history of malignancy, within the last 3 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 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

2012-002772-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3034-105

Identifier Type: -

Identifier Source: org_study_id