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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00943761
First received: July 21, 2009
Last updated: March 4, 2014
Last verified: March 2014
  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:


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

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 ]

Enrollment: 45
Study Start Date: October 2009
Study Completion Date: May 2013
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
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: NCT00943761     History of Changes
Other Study ID Numbers: 7009-028, 2009_615
Study First Received: July 21, 2009
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
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 August 18, 2014