Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/2/2019 |
| Start Date: | April 2014 |
| End Date: | December 27, 2018 |
Extension Study for Patients Who Completed GENA-05 (NuProtect)- to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII
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.
Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.
Inclusion Criteria:
1. Patients who completed GENA-05 in accordance with the study protocol
Exclusion Criteria:
1. Severe liver or kidney disease
2. Concomitant treatment with any systemic immunosuppressive drug;
3. Other FVIII concentrate than Human-cl rhFVIII was received between completion visit of
GENA-05 and start of GENA-15 (except emergency cases).
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