A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)
- Conditions
- Hepatitis C, Chronic
- Interventions
- Drug: Pegylated interferon
- Registration Number
- NCT00943761
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vaniprevir 600 mg b.i.d. + peg-IFN + RBV Vaniprevir 600 mg b.i.d. 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. Vaniprevir 300 mg b.i.d. + peg-IFN + RBV Pegylated interferon 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. Vaniprevir 600 mg b.i.d. + peg-IFN + RBV Pegylated interferon 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. Vaniprevir 300 mg b.i.d. + peg-IFN + RBV Vaniprevir 300 mg b.i.d. 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. Vaniprevir 300 mg b.i.d. + peg-IFN + RBV Ribavirin 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. Vaniprevir 600 mg b.i.d. + peg-IFN + RBV Ribavirin 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.
- Primary Outcome Measures
Name Time Method Number of Participants Who Experienced an Adverse Event up to 72 weeks An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24) 72 weeks SVR24 is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) 24 weeks after the end of vaniprevir study therapy. HCV RNA plasma levels were assessed using the Roche COBAS Taqman assay (or equivalent) with the limit of quantification (LoQ) of at least 25 IU/mL and the limit of detection (LoD) of at least 10 IU/mL.
Number of Participants Who Experienced a Serious Adverse Event up to 72 weeks Serious adverse event is defined as any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly or birth defect, was a cancer, or was an overdose.
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event 48 weeks An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
- Secondary Outcome Measures
Name Time Method