Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ribavirin · 1 trial · 2 indications
The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).
| Arm | Type | Description |
|---|---|---|
| 001 T(q8h) / PR | EXPERIMENTAL | Telaprevir (T) 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R) |
| 002 T(b.i.d.) / PR | EXPERIMENTAL | Telaprevir (T) 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R) |
| Name | Type | Description |
|---|---|---|
| Ribavirin | DRUG | Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4 |
| Telaprevir | DRUG | 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks |
| Pegylated interferon alfa-2a | DRUG | 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4 |
Inclusion Criteria: * Patient has chronic HCV infection genotype 1 with HCV RNA level \> 1,000 IU/mL * Patients should not have had any previous treatment for hepatitis C * Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have ...
Ribavirin is used for the treatment of Genotype 1 Chronic Hepatitis C in patients who have not previously been treated for the condition. It is being studied as part of a combination regimen in a Phase 3 clinical trial. The drug is a small molecule developed by Johnson & Johnson.
Ribavirin is a small molecule antiviral. Its specific molecular target is not disclosed in the available clinical trial information. The drug is being evaluated in combination with other agents for the treatment of Genotype 1 Chronic Hepatitis C.
Ribavirin is being developed by Johnson & Johnson, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the drug for the treatment of Genotype 1 Chronic Hepatitis C.
Ribavirin is in Phase 3 clinical development for the treatment of Genotype 1 Chronic Hepatitis C. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, with a total enrollment of 744 participants.
Ribavirin is associated with one completed Phase 3 clinical trial, identified as NCT01241760. This study evaluated a dosing regimen of telaprevir in treatment-naive participants with Genotype 1 Chronic Hepatitis C. The trial enrolled 744 participants across multiple countries, including the United States, Australia, and several European nations.
Ribavirin is not the same as telaprevir. The clinical trial NCT01241760 evaluated a dosing regimen of telaprevir in combination with other medications, and Ribavirin was part of the treatment regimen being studied. Ribavirin is a separate antiviral drug developed by Johnson & Johnson.