Safety and Efficacy of Vaniprevir (MK-7009) Administered With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-experienced HCV Participants (MK-7009-009)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00704405
First received: June 23, 2008
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

A study to test the safety, tolerability, and efficacy of 4 regimens of vaniprevir + Peg-IFN and RBV as compared to placebo + Peg-IFN and RBV.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Experienced Patients With Chronic Genotype 1 Hepatitis C Virus Infection

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety and tolerability of vaniprevir as assessed by review of accumulated safety data [ Time Frame: From baseline up to 72 weeks ] [ Designated as safety issue: Yes ]
  • Antiviral activity of 600 mg b.i.d. vaniprevir as assessed by proportion of participants achieving sustained viral response 24 weeks after completion of treatment [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antiviral activity of 300 mg b.i.d. vaniprevir as assessed by proportion of participants achieving sustained viral response 24 weeks after completion of treatment [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Antiviral activity of vaniprevir as assessed by proportion of participants achieving undetectable viral RNA at treatment week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants achieving sustained viral response after completion of treatment with 600 mg b.i.d. vaniprevir for 24 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 285
Study Start Date: March 2009
Study Completion Date: September 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaniprevir (600 mg) + peg-IFN + RBV (24 weeks) Drug: Vaniprevir (600 mg b.i.d.)
Capsules containing 100 mg vaniprevir, three in the morning and three in the evening, orally, for 24 or 48 weeks
Drug: Peg-IFN
Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks
Other Name: PEGASYS™
Drug: RBV
Tablet containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks
Other Name: COPEGUS™
Experimental: Vaniprevir(600mg)+peg-IFN+RBV/placebo+peg-IFN+RBV(24/24 weeks) Drug: Vaniprevir (600 mg b.i.d.)
Capsules containing 100 mg vaniprevir, three in the morning and three in the evening, orally, for 24 or 48 weeks
Drug: Peg-IFN
Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks
Other Name: PEGASYS™
Drug: RBV
Tablet containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks
Other Name: COPEGUS™
Drug: Placebo
Placebo to vaniprevir capsules, three in the morning and three in the evening, for 24 or 48 weeks
Experimental: Vaniprevir (300 mg) + peg-IFN + RBV (48 weeks) Drug: Vaniprevir (300 mg b.i.d.)
Capsules containing 100 mg vaniprevir, three in the morning, orally, for 48 weeks
Drug: Peg-IFN
Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks
Other Name: PEGASYS™
Drug: RBV
Tablet containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks
Other Name: COPEGUS™
Experimental: Vaniprevir (600 mg) + peg-IFN + RBV (48 weeks) Drug: Vaniprevir (600 mg b.i.d.)
Capsules containing 100 mg vaniprevir, three in the morning and three in the evening, orally, for 24 or 48 weeks
Drug: Peg-IFN
Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks
Other Name: PEGASYS™
Drug: RBV
Tablet containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks
Other Name: COPEGUS™
Placebo Comparator: Placebo + peg-IFN + RBV (48 weeks) Drug: Peg-IFN
Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks
Other Name: PEGASYS™
Drug: RBV
Tablet containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks
Other Name: COPEGUS™
Drug: Placebo
Placebo to vaniprevir capsules, three in the morning and three in the evening, for 24 or 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Chronic, genotype 1 hepatitis C infection
  • Treatment-experienced
  • For the non-cirrhotic patient population, patient has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma; for the cirrhotic patient population, patient has had a liver biopsy with evidence of cirrhosis and without evidence of hepatocellular carcinoma.

Exclusion criteria:

  • Has not tolerated previous course peg-IFN and RBV
  • Unlikely to tolerate at least 24 weeks of continuous therapy with peg-IFN and RBV
  • Human immunodeficiency virus (HIV) and/or active hepatitis B co-infection
  • Consumes excessive amounts of alcohol
  • Has a history of drug or alcohol abuse
  • If female, participant is pregnant or breastfeeding
  • Has been in a clinical trail with an investigational drug in the last 30 days
  • IFN/peg-IFN and RBV use in the last 3 months
  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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704405     History of Changes
Other Study ID Numbers: 7009-009, 2007_659, MK-7009-009
Study First Received: June 23, 2008
Last Updated: November 18, 2013
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 C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014