Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00943761 | A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028) | PHASE2 | COMPLETED | 45 | — | — | Oct 23, 2009 | May 29, 2013 | Feb 8, 2021 | - | — |
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Vaniprevir 300 mg b.i.d. + peg-IFN + RBV | EXPERIMENTAL | 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 | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Vaniprevir 600 mg b.i.d. | DRUG | Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks |
| Vaniprevir 300 mg b.i.d. | DRUG | Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks |
| Pegylated interferon | DRUG | Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks |
| Ribavirin | DRUG | 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 |
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 0...