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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: Vaniprevir 300 mg b.i.d.; Drug: Pegylated interferon; Drug: Ribavirin; Drug: Vaniprevir 600 mg b.i.d.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00943761

2009-013053-15 (EudraCT Number)

7009-028

2009_615 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant has participated in a prior vaniprevir clinical trial
• Participant agrees to use acceptable birth control method during treatment

Exclusion criteria

• More than one year has passed since the participant was determined to be eligible for enrollment in protocol 028
• Participant discontinued vaniprevir and/or peg-IFN and/or RBV in the prior study due to a safety or tolerability issue
• Participant received any investigational therapy for HCV after participating in the prior study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Vaniprevir 300 mg b.i.d. + peg-IFN + RBV

Experimental group

Description:

Participants received vaniprevir 300 mg twice daily (b.i.d.) in combination peg-IFN 180 mcg weekly and ribavirin (1000 or 1200 mg) administered as a divided dose twice daily.

Treatment:

Drug: Pegylated interferon

Drug: Ribavirin

Drug: Vaniprevir 300 mg b.i.d.

Vaniprevir 600 mg b.i.d. + peg-IFN + RBV

Experimental group

Description:

Participants received vaniprevir 600 mg b.i.d. in combination peg-IFN 180 mcg weekly and ribavirin (1000 or 1200 mg) administered as a divided dose twice daily.

Treatment:

Drug: Pegylated interferon

Drug: Ribavirin

Drug: Vaniprevir 600 mg b.i.d.