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)

NCT01945294 | Completed Phase 3 Results

• 1 other identifier: 3034-107
• Study Type: interventional
• Target: 257
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]

  SVR12 was declared when participants who had undetectable HCV RNA (HCV RNA \< Lower Limit of Quantification \[LLoQ\]) after the 12-week lead-in also had undetectable HCV RNA 12 weeks after completing their assigned BOC treatment regimen. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.

  Follow-up Week (FW) 12 (up to 40 weeks)

Secondary Outcomes (7)

• Percentage of Participants With Undetectable HCV RNA Across Treatment

  TW4, TW8, and TW12

• Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment

  TW4, TW8, and TW12

• Percentage of Participants With Relapse

  From EOT to FW12 (up to 12 weeks)

• Percentage of Participants With Neutropenia

  Up to 60 weeks

• Percentage of Participants With Anemia

  Up to 60 weeks

Study Arms (3)

Arm 1: 16-week Treatment Arm

EXPERIMENTAL

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).

Drug: Boceprevir; Biological: Peg-interferon alfa-2b; Drug: Ribavirin

Arm 2: 28-week Treatment Arm

EXPERIMENTAL

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).

Drug: Boceprevir; Biological: Peg-interferon alfa-2b; Drug: Ribavirin

Arm 3: 48-week Treatment Arm

EXPERIMENTAL

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).

Drug: Boceprevir; Biological: Peg-interferon alfa-2b; Drug: Ribavirin

Interventions

Boceprevir DRUG

800 mg three times daily orally

Also known as: MK-3034

Arm 1: 16-week Treatment Arm; Arm 2: 28-week Treatment Arm; Arm 3: 48-week Treatment Arm

Peg-interferon alfa-2b BIOLOGICAL

1.5 mcg/kg weekly subcutaneously

Also known as: PegIntron

Arm 1: 16-week Treatment Arm; Arm 2: 28-week Treatment Arm; Arm 3: 48-week Treatment Arm

Ribavirin DRUG

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

Also known as: Rebetol

Arm 1: 16-week Treatment Arm; Arm 2: 28-week Treatment Arm; Arm 3: 48-week Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2013
• First Posted: September 18, 2013
• Study Start: October 10, 2013
• Primary Completion: August 5, 2015
• Study Completion: November 4, 2015
• Last Updated: July 12, 2018
• Results First Posted: November 23, 2016

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share