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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01994486 | Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1 | PHASE2 | COMPLETED | 20 | — | — | Dec 1, 2013 | Sep 1, 2014 | Apr 23, 2018 | 1 | United States |
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...