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A Study of Vaniprevir (MK-7009) in Patients With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028 AM5)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00943761
First received: July 21, 2009
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

This study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated interferon and ribavirin to participants with chronic hepatitis C virus (HCV) infection who did not achieve viral eradication while participating in a prior vaniprevir clinical trial.


Condition Intervention Phase
Hepatitis C, Chronic
 Drug: Vaniprevir (600 mg b.i.d.)
Drug: Vaniprevir (300 mg b.i.d.)
Drug: Pegylated interferon (Peg-IFN)
Drug: Ribavirin (RBV)
 Phase 2

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 II Open Label Study of MK-7009 Administered Concomitantly With Pegylated Interferon Alfa-2a and Ribavirin to Patients With Chronic Hepatitis C Infection After Participation in Other MK-7009 Clinical Trials

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with serious adverse events [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants achieving sustained viral response 24 weeks after the end of treatment (SVR24) [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaniprevir (600 mg b.i.d.) + peg-IFN + RBV Drug: Vaniprevir (600 mg b.i.d.)
Capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks
Drug: Pegylated interferon (Peg-IFN)
Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks
Other Name: PEGASYS™
Drug: Ribavirin (RBV)
Tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight, for 48 weeks
Other Name: COPEGUS™
Experimental: Vaniprevir (300 mg b.i.d.) + peg-IFN + RBV Drug: Vaniprevir (300 mg b.i.d.)
Capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks
Drug: Pegylated interferon (Peg-IFN)
Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks
Other Name: PEGASYS™
Drug: Ribavirin (RBV)
Tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight, for 48 weeks
Other Name: COPEGUS™

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Participant has participated in a prior vaniprevir clinical trial
  • Participant agrees to use acceptable birth control method during treatment

Exclusion criteria:

  • More than one year has passed since the participant was determined to be eligible for enrollment in protocol 028
  • Participant discontinued vaniprevir and/or peg-IFN and/or RBV in the prior study due to a safety or tolerability issue
  • Participant received any investigational therapy for HCV after participating in the prior study
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00943761     History of Changes
Other Study ID Numbers: 7009-028, 2009_615
Study First Received: July 21, 2009
Last Updated: December 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
hepatitis C

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
Interferons
Ribavirin
Peginterferon alfa-2a
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013