Phase 3
N=110
Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients
Severe Hemophilia A
Bottom Line
View on ClinicalTrials.gov: NCT01712438 ↗Enrolled (actual)
110
Serious AEs
44.4%
Results posted
Oct 2019
Primary outcome: Primary: Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors — 17; 11; 28 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Human cl rhFVIII (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Male
- Sponsor
- Octapharma
- Primary completion
- Dec 2018
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 | — |
Summary
Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.
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.