Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Telaprevir and Sofosbuvir · 1 trial · 1 indication
Study drug adherence and adverse events were collected on all enrolled subjects and graded using the DAIDS scale. Any adverse events leading to discontinuation of both Telaprevir and Sofosbuvir were collected and are hereby reported.
The number of subjects who experienced Grade 3 anemia. Complete blood count was collected at baseline, week 2, week 4, week 8, week 12, week 18, and week 24. Incidence of moderate anemia (Grade 3) observed in the study treatment period.
| Arm | Type | Description |
|---|---|---|
| Telaprevir and Sofosbuvir | EXPERIMENTAL | All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Telaprevir and Sofosbuvir | DRUG | All subjects will have time to read and discuss IRB approved consent form prior to any study procedures. Following proper consenting, subjects will undergo physical exam including ECG and bloodwork prior to baseline visit. Subjects will return for research visits (vitals, collection of AEs, bloodwork, drug accountability) on Day 3, Weeks 1, 2, 3, 4, 6, 8, 10 and 12 of treatment and 4, 12, and 24 weeks after end of treatment. PK samples will be collected at week 2 and week 10. |
Inclusion Criteria: * Willing and able to provide informed consent * BMI (Body Mass Index) ≥ 18 kg/m2 * HCV RNA quantifiable at screening and \>1,000 IU/ml * HCV treatment Naïve * HCV genotype 1 * 7\. Confirmation of chronic HCV infection documented by either: A positive anti-HCV antibody test or p...
Telaprevir is an investigational small molecule being developed for the treatment of chronic Hepatitis C, Hepatitis C, and hepatic insufficiency. It is being studied in patients with these conditions, and clinical trials have also examined its effects in healthy volunteers.
Telaprevir is being developed by Vertex Pharmaceuticals Incorporated, a company listed on the stock exchange under the ticker VRTX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating Hepatitis C and related conditions.
Telaprevir is in Phase 2 clinical development. It has completed a total of five trials, with no active trials currently ongoing. All five trials have been completed, including Phase 2 and Phase 1 studies.
Telaprevir has been studied in several completed clinical trials, including NCT00336479, a Phase 2 study in chronic Hepatitis C; NCT00509210, a study in hepatic impairment; NCT01038167, a drug interaction study; and NCT01275599, a drug interaction study with buprenorphine.
Telaprevir is also known as VX-950. In clinical trials, it has been referred to by both names, such as in the Phase 2 study titled 'Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C'.