NCT00943761

A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)

A Phase II Open Label Study of MK-7009 Administered Concomitantly With Pegylated Interferon Alfa-2a and Ribavirin to Patients With Chronic Hepatitis C Infection After Participation in Other MK-7009 Clinical Trials

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated interferon (peg-IFN) and ribavirin (RBV) to participants with chronic hepatitis C virus (HCV) infection who did not achieve viral eradication while participating in a prior vaniprevir clinical trial (MK-7009-004, NCT00518622; MK-7009-007, NCT00704405; MK-7009-009, NCT00704184; and MK-7009-029, NCT00954993).

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Vaniprevir 600 mg b.i.d.	Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks
DRUG	Vaniprevir 300 mg b.i.d.	Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks
DRUG	Pegylated interferon	Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks
DRUG	Ribavirin	Oral tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight (\<75 kg or ≥75 kg, respectively), for 48 weeks

Timeline

• Start date: 2009-10-23
• Primary completion: 2013-05-29
• Completion: 2013-05-29
• First posted: 2009-07-22
• Last updated: 2021-02-08
• Results posted: 2014-09-29