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Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Are Non-responders to Previous Treatment (MK-7009-045 AM2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01405560
First received: July 28, 2011
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with peg-IFN alfa-2b and ribavirin (RBV) in Japanese participants with chronic hepatitis C (CHC) genotype (GT) 1 who have not responded to previous treatment.


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

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

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

Enrollment: 42
Study Start Date: September 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaniprevir 24 week arm
Participants receive 24 weeks of vaniprevir with concomitant peg-IFN alfa-2b and RBV treatment
 Drug: 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
Open-label peg-IFN alfa-2b at 1.5 μg/kg once per week, administered subcutaneously (SC) for 24 weeks
Other Name: PegIntron
Drug: ribavirin
Capsules containing 200 mg RBV, orally, 3 to 5 capsules, dosage based on the participant's 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

  • Japanese participant diagnosed as compensated CHC GT 1
  • has received and tolerated treatment with IFN-based therapy (IFN α, IFN β , or peg-IFN) with or without use of ribavirin, but failed to respond to the prior treatment (partial responder or null responder)
  • No evidence of cirrhosis
  • Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease.

Exclusion criteria

  • Co-infection with human immunodeficiency virus (HIV).
  • Positive hepatitis B surface antigen or other evidence of active hepatitis B infection
  • Any other condition that is contraindicated or for which caution is required for treatment with peg IFN alfa-2b or RBV
  • Any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg IFN alfa-2b and RBV, to the patient.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01405560     History of Changes
Other Study ID Numbers: 7009-045
Study First Received: July 28, 2011
Last Updated: April 9, 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 Alfa-2a
Interferon-alpha
 Interferon Alfa-2b
Ribavirin
Peginterferon alfa-2b
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013