Phase 3
Completed N=66
Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Patients With Severe Haemophilia A
Severe Haemophilia A
Source: ClinicalTrials.gov NCT01863758 ↗
Enrolled (actual)
66
Serious AEs
7.6%
Results posted
Jan 2018
Primary outcomePrimary: Annualized Number of Bleeding Episodes (BE) in Phase II — 3.05 Annualized number of bleeding episodes — p=<0.05
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
To compare the number of breakthrough bleeds under tailored prophylaxis with Human cell line recombinant factor FVIII (Human-cl rhFVIII) with the historical bleeding rate from patients who received Human-cl rhFVIII as on demand treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Number of Bleeding Episodes (BE) in Phase II |
3.05 | <0.05 sig |
| SECONDARY Annualized Number of Spontaneous Bleeding Episodes (BE) in Phase II |
1.84 | <0.05 sig |
| SECONDARY Annualized Number of Bleeding Episodes (BE) in Phase II in Participants With ≤ 2 Treatments/Week |
4.1 | — |
| SECONDARY Median Dosing Interval During Individually Tailored Prophylaxis |
83.1; 83.3 | — |
| SECONDARY Dosage Per Week in Phase II |
97.7 | — |
Eligibility Criteria
Inclusion Criteria
- Severe haemophilia A (FVIII:C 200/microliter).
- HIV-negative, if positive, viral load 0.6 Bethesda Unit [BU])
- Severe liver or kidney disease.
Data sourced from ClinicalTrials.gov (NCT01863758). 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.