Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00704184
First received: June 23, 2008
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus [HCV] viral ribonucleic acid [RNA] at Week 4 in participants with chronic HCV infection. The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFN/Ribavirin.


Condition Intervention Phase
Hepatitis C
Drug: Comparator: Vaniprevir
Drug: Comparator: Pegylated-Interferon (Peg-IFN)
Drug: Comparator: Ribavirin
Drug: Comparator: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naive Patients With Chronic Hepatitis C Infection

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of Participants Achieving RVR [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.

  • Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to Day 42 ] [ Designated as safety issue: Yes ]
    The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.

  • Number of Participants Discontinuing From Study Therapy Due to AEs [ Time Frame: Day 1 to Day 28 ] [ Designated as safety issue: Yes ]
    An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.


Secondary Outcome Measures:
  • Number of Participants With ≥2-log10 Decrease in HCV RNA [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.

  • Number of Participants With ≥3-log10 Decrease in HCV RNA [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.

  • Mean Log Change From Baseline in HCV RNA [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.


Enrollment: 95
Study Start Date: July 2008
Study Completion Date: April 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo + Peg-IFN/Ribavirin
Participants took double-blind Placebo + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Drug: Comparator: Pegylated-Interferon (Peg-IFN)
Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
Drug: Comparator: Ribavirin
Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks
Experimental: Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 300 mg twice daily (b.i.d.) + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Drug: Comparator: Vaniprevir
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
Other Name: MK-7009
Drug: Comparator: Pegylated-Interferon (Peg-IFN)
Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
Drug: Comparator: Ribavirin
Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks
Experimental: Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Drug: Comparator: Vaniprevir
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
Other Name: MK-7009
Drug: Comparator: Pegylated-Interferon (Peg-IFN)
Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
Drug: Comparator: Ribavirin
Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks
Experimental: Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Drug: Comparator: Vaniprevir
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
Other Name: MK-7009
Drug: Comparator: Pegylated-Interferon (Peg-IFN)
Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
Drug: Comparator: Ribavirin
Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks
Experimental: Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Drug: Comparator: Vaniprevir
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
Other Name: MK-7009
Drug: Comparator: Pegylated-Interferon (Peg-IFN)
Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
Drug: Comparator: Ribavirin
Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks
Drug: Comparator: placebo
Matching placebo to vaniprevir; duration of treatment: 28 days

  Eligibility

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

Inclusion Criteria:

  • Patient has chronic Genotype 1 Hepatitis C infection

Exclusion Criteria:

  • Subject has been previously treated for HCV
  • Has Human Immunodeficiency Virus (HIV)
  • Has Hepatitis B
  • 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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704184

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704184     History of Changes
Other Study ID Numbers: 7009-007, MK7009-007, 2007_658
Study First Received: June 23, 2008
Results First Received: September 26, 2014
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferons
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014