Short Duration Versus Standard Response-Guided Therapy With Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Asian Participants With Chronic HCV Genotype 1 (MK-3034-107)

NCT ID: NCT01945294

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 257 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-10
• Study Completion Date: 2015-11-04

Brief Summary

The purpose of this study is to estimate the difference in the efficacy between a 16-week treatment regimen of boceprevir (BOC) in combination with peg-intron alpha 2b (P) plus ribavirin (R) (BOC + PR) and a 28-week treatment regimen of BOC + PR in previously untreated participants with chronic hepatitis C (CHC) genotype 1 in Asia who achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA).

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: 16-week Treatment Arm

All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).

Group Type: EXPERIMENTAL

Boceprevir

Intervention Type: DRUG

800 mg three times daily orally

Peg-interferon alfa-2b

Intervention Type: BIOLOGICAL

1.5 mcg/kg weekly subcutaneously

Ribavirin

Intervention Type: DRUG

800-1400 mg twice-daily divided orally based on body weight

Arm 2: 28-week Treatment Arm

All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).

Group Type: EXPERIMENTAL

Boceprevir

Intervention Type: DRUG

800 mg three times daily orally

Peg-interferon alfa-2b

Intervention Type: BIOLOGICAL

1.5 mcg/kg weekly subcutaneously

Ribavirin

Intervention Type: DRUG

800-1400 mg twice-daily divided orally based on body weight

Arm 3: 48-week Treatment Arm

All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).

Group Type: EXPERIMENTAL

Boceprevir

Intervention Type: DRUG

800 mg three times daily orally

Peg-interferon alfa-2b

Intervention Type: BIOLOGICAL

1.5 mcg/kg weekly subcutaneously

Ribavirin

Intervention Type: DRUG

800-1400 mg twice-daily divided orally based on body weight

Interventions

Boceprevir

800 mg three times daily orally

Intervention Type: DRUG

Peg-interferon alfa-2b

1.5 mcg/kg weekly subcutaneously

Intervention Type: BIOLOGICAL

Ribavirin

800-1400 mg twice-daily divided orally based on body weight

Intervention Type: DRUG

Other Intervention Names

MK-3034; PegIntron; Rebetol

Eligibility Criteria

Inclusion Criteria

• weigh ≥ 40 kg and ≤ 125 kg
• have CHC genotype 1 infection
• has had a liver biopsy or non-invasive liver fibrosis test that shows no evidence of cirrhosis and hepatocellular carcinoma
• must agree that the participant and the participant's partner will each use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations (for a female participant who is of childbearing potential or male participant with female sexual partner who is of childbearing potential)

Exclusion Criteria

• participates in any other interventional clinical trial within 30 days of the screening visit in this trial or intends to participate in another interventional clinical trial during participation in this trial
• is co-infected with human immunodeficiency virus (HIV) or hepatitis B virus
• has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis
• has evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
• has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
• has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
• has been previously treated with an interferon or ribavirin regimen or HCV direct acting anti-viral regimen, or treated for hepatitis C with any investigational medication
• taking/plans to take significant inducers of inhibitors of Cytochrome P450 3A4 (CYP3A4) substrates 2 weeks prior to start of study medications, or herbal supplements, including but not limited to St. John's Wort 2 weeks prior to start of study medications (Day 1)
• has pre-existing psychiatric condition(s)
• has a clinical diagnosis of substance abuse
• has any known medical condition that could interfere with the participation in and completion of the trial including immunologically-mediated disease, chronic pulmonary disease, or current or history of any clinically significant cardiac abnormalities/dysfunction
• is pregnant or nursing (for female participant) or female partner intends to become pregnant (for male participant)

• 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

3034-107

Identifier Type: -

Identifier Source: org_study_id