Status:

COMPLETED

A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016)

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Hepatitis C

Eligibility:

All Genders

20-64 years

Phase:

PHASE2

Brief Summary

The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with Pegylated-Interferon (peg-IFN) and Ribavirin, in Japanese patients with Hepatitis C infection. The primary hypoth...

Eligibility Criteria

Inclusion

  • Has chronic genotype 1 Hepatitis C infection

Exclusion

  • Has not tolerated previous course of peg-IFN and ribavirin
  • Has 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

Key Trial Info

Start Date :

April 20 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 23 2012

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT00880763

Start Date

April 20 2009

End Date

February 23 2012

Last Update

October 9 2018

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