Phase 3
Completed N=51
Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia
Source: ClinicalTrials.gov NCT01741545 ↗Enrolled (actual)
51
Serious AEs
7.8%
Results posted
Jun 2019
Primary outcomePrimary: Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12 — 91.7; 89.7 Percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12 |
91.7; 89.7 | — |
| SECONDARY Percentage of Participants With Rapid Virologic Response (RVR) |
91.7; 76.9 | — |
| SECONDARY Percentage of Participants With Complete Early Virologic Response (cEVR) |
91.7; 92.3 | — |
| SECONDARY Percentage of Participants With End of the Treatment Response (EOTR) |
100; 100 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24) |
66.7; 30.8 | — |
| SECONDARY Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment |
0; 0 | — |
| SECONDARY Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment |
8.3; 12.8; 0; 15.4 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death |
10; 38; 0; 4; 0; 0 | — |
| SECONDARY Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities |
0; 1; 2; 1; 0; 2 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria
- Severe hemophilia (defined as < 1% factor activity level)
- Infection with the hepatitis C virus (HCV) with underlying hemophilia
- Males 18 years of age and above
- Have not been previously treated with an interferon
Exclusion Criteria
- Not infected with the hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Chronic liver disease caused by any disease other than chronic HCV infection
- Presence of Bethesda inhibitor
- Current evidence of or history of portal hypertension
Data sourced from ClinicalTrials.gov (NCT01741545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.