Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vaniprevir b.i.d · 1 trial · 1 indication
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...
Vaniprevir b.i.d is an investigational small molecule being studied for the treatment of chronic hepatitis C. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 2 clinical development. The drug is intended for patients with chronic hepatitis C infection.
Vaniprevir b.i.d is a small molecule drug being developed for chronic hepatitis C. While its specific molecular target is not disclosed in the available information, it is being studied as a direct-acting antiviral agent. The drug is in Phase 2 clinical trials for this indication.
Vaniprevir b.i.d is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 2 clinical development for the treatment of chronic hepatitis C.
Vaniprevir b.i.d is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of chronic hepatitis C, with one completed Phase 2 trial involving 45 participants.
Vaniprevir b.i.d has been studied in one clinical trial, identified as NCT00943761. This was a Phase 2 study titled 'A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028).' The trial has been completed and enrolled 45 participants.
Yes, Vaniprevir b.i.d is also known as MK-7009. The clinical trial NCT00943761 refers to the drug as MK-7009, and it is being developed by Merck & Company, Inc. for the treatment of chronic hepatitis C. The drug is currently in Phase 2 development.