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

Phase 2

Completed

• Conditions: Hepatitis C

• Registration Number: NCT00704184
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-24
• Study Start: 2008-07-25
• Primary Completion: 2008-12-12
• Study Completion: 2010-04-14
• Results First Submitted: 2014-09-26
• Results First Submitted QC: 2014-09-26
• Results First Posted: 2014-10-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• Patient has chronic Genotype 1 Hepatitis C infection

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving RVR	Week 4	Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.
Number of Participants Discontinuing From Study Therapy Due to AEs	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.
Number of Participants Experiencing an Adverse Event (AE)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With ≥2-log10 Decrease in HCV RNA	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.
Number of Participants With ≥3-log10 Decrease in HCV RNA	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.
Mean Log Change From Baseline in HCV RNA	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.