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)

NCT01756079 | Completed Phase 4 Results

• 2 other identifiers: 3034-1052012-002772-13
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)

  Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using a polymerase chain reaction assay. SVR24 was defined as HCV RNA less than the Limit of Quantification (\<25 International Units (IU)/mL) 24 weeks after the end of the Treatment Period.

  Week 72 (24 weeks after end of treatment)

• Percentage of Participants With One or More Adverse Events

  Adverse events were monitored during the Lead-in and Treatment Periods

  Up to 48 weeks (Lead-in and Treatment Periods)

• Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication

  Adverse events were monitored during the Lead-in and Treatment Periods

  Up to 48 weeks (Lead-in and Treatment Periods)

Study Arms (1)

PegIFN-2b + RBV+ boceprevir

EXPERIMENTAL

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).

Drug: boceprevir; Biological: PegIFN-2b; Drug: RBV

Interventions

boceprevir DRUG

Also known as: SCH 503034

PegIFN-2b + RBV+ boceprevir

PegIFN-2b BIOLOGICAL

Also known as: Peginterferon alfa-2b, PegIntron, SCH 054031

PegIFN-2b + RBV+ boceprevir

RBV DRUG

Also known as: Ribavirin, Rebetol

PegIFN-2b + RBV+ boceprevir

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C

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)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

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 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: December 24, 2012
• Study Start: February 6, 2013
• Primary Completion: November 17, 2015
• Study Completion: November 17, 2015
• Last Updated: September 5, 2018
• Results First Posted: November 21, 2016

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share