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Completed

NCT Number: NCT00704184

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

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: Vaniprevir

Drug

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 names: MK-7009

Comparator: Pegylated-Interferon (Peg-IFN)

Drug

Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks

Comparator: Ribavirin

Drug

Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks

Comparator: placebo

Drug

Matching placebo to vaniprevir; duration of treatment: 28 days

Primary outcomes

  1. Percentage of Participants Achieving RVR

    Time frame: Week 4

    Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.

  2. Number of Participants Experiencing an Adverse Event (AE)

    Time frame: Up to Day 42

    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.

  3. Number of Participants Discontinuing From Study Therapy Due to AEs

    Time frame: Day 1 to Day 28

    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 outcomes

  1. Number of Participants With ≥2-log10 Decrease in HCV RNA

    Time frame: Baseline and Week 4

    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.

  2. Number of Participants With ≥3-log10 Decrease in HCV RNA

    Time frame: Baseline and Week 4

    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.

  3. Mean Log Change From Baseline in HCV RNA

    Time frame: Baseline and Week 4

    The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2010
First posted
Jun 24, 2008
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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