Study of Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Relapsed After Treatment (MK-7009-044 AM3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01405937
First received: July 28, 2011
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (PegIntron®/peg-IFN alfa-2b) and ribavirin (RBV) in chronic hepatitis C (CHC) Genotype I participants who relapsed after previous therapy with interferon-based therapy.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: vaniprevir
Biological: peg-IFN alfa-2b
Drug: ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Concomitantly Administered With Peginterferon Alfa-2b and Ribavirin in Japanese Patients With Chronic Hepatitis C Infection Who Relapsed After Previous Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of participants achieving sustained virologic response (SVR)24 [ Time Frame: 24 weeks after 24 weeks of study therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants achieving SVR12 [ Time Frame: 12 weeks after 24 weeks of study therapy ] [ Designated as safety issue: No ]
  • Proportion of participants achieving rapid virologic response (RVR) [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
  • Proportion of participants achieving complete early virologic response (cEVR) [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
  • Proportion of participants achieving undetectable HCV ribonucleic acid (RNA) at the end of treatment (EOT) [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: August 2011
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaniprevir 12 Week Arm
Participants on this arm receive 12 weeks of vaniprevir along with 24 weeks of treatment with peg-IFN alfa-2b and RBV
Drug: vaniprevir
vaniprevir capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 weeks
Other Name: MK-7009
Biological: peg-IFN alfa-2b
peg-IFN alfa-2b 1.5 µg/kg once per week, subcutaneously (SC) for 24 weeks
Other Name: PegIntron®
Drug: ribavirin
Capsules containing 200 mg ribavirin, orally, 3 to 5 capsules, dosage based on participant weight, for 24 weeks
Other Name: REBETOL®
Experimental: Vaniprevir 24 Week Arm
Participants on this arm receive 24 weeks of vaniprevir along with 24 weeks of treatment with peg-IFN alfa-2b and RBV
Drug: vaniprevir
vaniprevir capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 24 weeks
Other Name: MK-7009
Biological: peg-IFN alfa-2b
peg-IFN alfa-2b 1.5 µg/kg once per week, subcutaneously (SC) for 24 weeks
Other Name: PegIntron®
Drug: ribavirin
Capsules containing 200 mg ribavirin, orally, 3 to 5 capsules, dosage based on participant weight, for 24 weeks
Other Name: REBETOL®

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Participant Has Chronic Genotype 1 Hepatitis C Infection previously treated with and relapsing after interferon-based therapy

Exclusion Criteria:

  • Participant Has Not Tolerated Previous Course Of Peg-IFN And Ribavirin
  • Participant Has HIV
  • Participant Has Hepatitis B
  • Participant Has A History Of Clinically Significant Medical Condition That May Interfere With The Study (e.g., Stroke Or Chronic Seizures Or Major Neurological Disorder) Or Is Contraindicated For Treatment With Peg-IFN And Ribavirin
  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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01405937     History of Changes
Other Study ID Numbers: 7009-044
Study First Received: July 28, 2011
Last Updated: December 18, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Ribavirin
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014