Conditions: Hepatitis C, Chronic
Keywords: hepatitis C
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 45
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Vaniprevir 600 mg b.i.d. intervention 2: Vaniprevir 300 mg b.i.d. intervention 3: Pegylated interferon intervention 4: Ribavirin
Intervention descriptions: intervention 1: Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks intervention 2: Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks intervention 3: Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks intervention 4: 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

Protocol document: