Phase 3
Completed N=48
Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII
Source: ClinicalTrials.gov NCT01992549 ↗Enrolled (actual)
48
Serious AEs
10.4%
Results posted
Dec 2019
Primary outcomePrimary: Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors — 0 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 This can indicate results are unpublished — a known publication-bias signal.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 purpose of the study is to collect long-term data on 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 |
— | — |
| SECONDARY Frequency of Spontaneous Break-through Bleeds |
0.283 | — |
| SECONDARY Efficacy of Human-cl rhFVIII for the Treatment of Bleeds |
58; 28; 21; 3; 1 | — |
| SECONDARY Efficacy of Human-cl rhFVIII for Surgical Prophylaxis |
0; 2; 2; 0; 0; 0 | — |
| SECONDARY The Occurrence of Any Adverse Event (AE) |
29; 5; 3; 20; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who completed GENA-05 in accordance with the study protocol
Exclusion Criteria
- Severe liver or kidney disease
- Concomitant treatment with any systemic immunosuppressive drug;
- Other FVIII concentrate than Human-cl rhFVIII was received between completion visit of GENA-05 and start of GENA-15 (except emergency cases).
Data sourced from ClinicalTrials.gov (NCT01992549). 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.