Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: December 19, 2012
Last updated: November 29, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Hepatitis C
Drug: boceprevir
Biological: PegIFN-2b
Drug: RBV
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-centre Single-arm Study to Evaluate the Efficacy and Safety of BOCEPREVIR 44 Weeks in Addition to Standard of Care (SOC) in Previously Treatment Failure (Relapser, Non-responders, Both Partial and Null) Patients With Chronic Hepatitis C Genotype 1 (G1) and Cirrhosis (F4 Metavir). (MK-3034-105-00)

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants who achieve sustained viral response (SVR) at 24 weeks after the end of all study treatment [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: February 2013
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Drug: boceprevir
Other Name: SCH 503034
Biological: PegIFN-2b
Other Names:
  • Peginterferon alfa-2b
  • PegIntron
  • SCH 054031
Drug: RBV
Other Names:
  • Ribavirin
  • Rebetol


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01756079     History of Changes
Other Study ID Numbers: 3034-105  2012-002772-13 
Study First Received: December 19, 2012
Last Updated: November 29, 2015
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents processed this record on October 21, 2016