Phase 3
Completed N=110
Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients
Source: ClinicalTrials.gov NCT01712438 ↗Enrolled (actual)
110
Serious AEs
44.4%
Results posted
Oct 2019
Primary outcomePrimary: Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors — 17; 11; 28 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 This can indicate results are unpublished — a known publication-bias signal.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
Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors |
17; 11; 28 | — |
| SECONDARY Frequency of Spontaneous Break-through Bleeds |
0.976 | — |
| SECONDARY Efficacy of Human-cl rhFVIII for the Treatment of Bleeds |
510; 237; 51; 6 | — |
| SECONDARY Efficacy of Human-cl rhFVIII for Surgical Prophylaxis |
7; 8; 15; 1; 2; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Male patients
- Severe Hemophilia A (FVIII:C <1%)
- No previous treatment with FVIII concentrates or other blood products containing FVIII
Exclusion Criteria
- Diagnosis with a coagulation disorder other than Hemophilia A
- Severe liver or kidney disease
- Concomitant treatment with any systemic immunosuppressive drug
Data sourced from ClinicalTrials.gov (NCT01712438). 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.