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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01704521 | Viral Kinetics in HCV Clearance in Subjects With Hemophilia | PHASE1 | COMPLETED | 5 | — | — | Dec 1, 2012 | Oct 1, 2014 | Apr 6, 2015 | 1 | United States |
Viral kinetic assessment using SVR 12 to either "lead-in" 4 weeks with PegInterferon + Ribavirin or no lead-in, followed by response guided therapy of 24 or 48 weeks based on viral response to treatment. Standard of care treatment stopping rules will be followed with assessment of viral response at week 12 of treatment.
| Arm | Type | Description |
|---|---|---|
| Lead-In | ACTIVE_COMPARATOR | Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin |
| No Lead-in | ACTIVE_COMPARATOR | Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegIntereron + Ribavirin |
| Name | Type | Description |
|---|---|---|
| PegInterferon | DRUG | - |
| Ribavirin | DRUG | - |
| Telaprevir | DRUG | - |
Inclusion Criteria: 1. Hemophilia A or B 2. HCV RNA positive (PCR or branched-chain DNA Methods), Genotype 1 (a/b, mixed and unknown subtype) 3. Chronic HCV infection evidenced by HCV serology, HCV RNA or liver enzyme abnormalities present at least 6 months prior to enrollment 4. Liver biopsy or no...