Brief Title
Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A
Official Title
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
Brief Summary
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Annualized Total Bleeding Rate of Individually Tailored Prophylaxis
Secondary Outcome
Annualized Spontaneous Bleeding Rate of Individually Tailored Prophylaxis
Condition
Severe Haemophilia A
Intervention
Human cl rhFVIII
Study Arms / Comparison Groups
Human-cl rhFVIII
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
58
Start Date
May 2015
Completion Date
September 2018
Primary Completion Date
September 2018
Eligibility Criteria
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
Gender
Male
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Craig M Kessler, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02256917
Organization ID
GENA-21B
Responsible Party
Sponsor
Study Sponsor
Octapharma
Study Sponsor
Craig M Kessler, MD, Principal Investigator, Georgetown University
Verification Date
December 2020