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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 is currently recruiting participants.
Verified March 2013 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01756079
First received: December 19, 2012
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

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: Safety/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:

U.S. FDA Resources

Further study details as provided by Merck:

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 ]

Estimated Enrollment: 80
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, bleeding varices, or hepatic encephalopathy
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756079

Locations
Italy
MSD Italia S.r.l.. Recruiting
Rome, Italy, 189
Contact: Patrizia Nardini     39 06 361911        
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01756079     History of Changes
Other Study ID Numbers: 3034-105, 2012-002772-13
Study First Received: December 19, 2012
Last Updated: March 1, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Fibrosis
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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013