Phase 3 N=66 Prevention

Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Patients With Severe Haemophilia A

Severe Haemophilia A

Bottom Line

View on ClinicalTrials.gov: NCT01863758 ↗

Enrolled (actual)

Serious AEs

7.6%

Results posted

Jan 2018

Primary outcome: Primary: Annualized Number of Bleeding Episodes (BE) in Phase II — 3.05 Annualized number of bleeding episodes — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Human-cl rhFVIII (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Octapharma
Primary completion: Jan 2015

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.