Haemophilia A MedDRA version: 9.1 Level: LLT Classification code 10060612 Term: Hemophilia A
Conditions
Interventions
Product Name: Human coagulation factor VIII (FACTANE 200 IU/ml): powder and solvent for solution intravenous use
Product Code: FACTANE 200 IU/ml
Pharmaceutical Form: Powder and solvent for solution fo
Sponsors
LFB BIOTECHNOLOGIES
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Severe haemophilia A patients (basal levels FVIII:C =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Present or past factor VIII inhibitor titre (defined as =0.6 Bethesda Units) (last test = 3 months). 2. Known intolerance to any of the ingredients of FACTANE 3. Participation in another clinical study involving an investigational drug within the past 30 days or on going participation in another clinical study. 4. Any other condition that the Investigator believes could interfere with the study results or would not be in the best interest of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Recovery Study Part The primary objective of this clinical research part is to compare the recovery of FACTANE 200 IU/ml with FACTANE 100 IU/ml, when given as a 4 ml/minute intravenous bolus injection. Safety Study Part The primary objective of this clinical research part is to assess the safety of FACTANE 200 IU/ml for at least 9 injections or 3 months whichever is sooner during standard-of-care treatment (on-demand, prophylaxis). ;Secondary Objective: Recovery Study Part The secondary objective of this clinical research part is to compare the local and immediate safety of FACTANE 200 IU/ml with FACTANE 100 IU/ml, when given as a 4 ml/minute intravenous bolus injection. Safety Study Part The secondary objective of this clinical research part is to evaluate the recovery of FACTANE 200 IU/ml after the last injection (re-test recovery).;Primary end point(s): • Recovery Study Part Recovery at T15 min after the end of injection of the IMPs in 12 patients is the primary endpoint. Recovery studies will be based on results using both chromogenic and one-stage clotting methods. • Safety Study Part The safety assessment will be based on the exposure at least 9 consecutive injections by patient of FACTANE 200 IU/ml in 12 patients. Overall tolerability by patient will be assessed by the investigator at the end of study visit using the same 4-point verbal scale. Tolerability will be based on adverse drug reactions reported by the patient. Each adverse event will be analysed with regards to causality, seriousness and expectedness. Immunogenicity will be based on - inhibitor screening at the last injection. A FVIII inhibitor titre =0.6 Bethesda Unit at the central laboratory will be considered as positive result. - control recovery after the last injection. A recovery ratio (control/initial) more than 0.66 will be considered as a stable recovery. | — |
Countries
France
Outcome results
None listed