Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/24/2019 |
| Start Date: | May 2015 |
| End Date: | September 2018 |
Prospective, Open-label, Multi-centre Phase 3b Study to Assess the Efficacy and Safety of Personalized Prophylaxis With Human-cl rhFVIII in Previously Treated Adult Patients With Severe Haemophilia A
The rationale of this study is to further fine-tune and individualize prophylactic treatment
of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above
1% between doses. Because trough FVIII levels are likely to be important predictors of the
efficacy of prophylaxis, the focus of this study is on PK data.
of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above
1% between doses. Because trough FVIII levels are likely to be important predictors of the
efficacy of prophylaxis, the focus of this study is on PK data.
Inclusion Criteria:
- Severe Haemophilia A (FVIII:C < 1%)
- Male patients >= 18 years of age
- Previous treatment with a FVIII concentrate for at least 150 EDs
- Good documentation regarding dosing and bleeding frequency in the 6 months preceding
study start
- Immunocompetence (CD4+ cound > 200/ul)
Exclusion Criteria:
- Any coagulation disorder other than Haemophilia A
- Present of past FVIII inhibitor activity
- Severe liver or kidney disease
We found this trial at
10
sites
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