Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A
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 pharmacokinetic (PK) data.
Annualized Total Bleeding Rate of Individually Tailored Prophylaxis
Annualized Spontaneous Bleeding Rate of Individually Tailored Prophylaxis
Severe Haemophilia A
Human cl rhFVIII
Study Arms / Comparison Groups
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
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+ count > 200/uL) Exclusion Criteria: - Any coagulation disorder other than Haemophilia A - Present of past FVIII inhibitor activity - Severe liver or kidney disease
18 Years - N/A
Accepts Healthy Volunteers
Craig M Kessler, MD, ,
Craig M Kessler, MD, Principal Investigator, Georgetown University