HAEMOPHILIA A MedDRA version: 14.1 Level: LLT Classification code 10018938 Term: Haemophilia A (Factor VIII) System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Product Name: FACTANE 200 IU/ml
Product Code: F8VR
Pharmaceutical Form: Powder and solvent for solution for injection
Other descriptive name: HUMAN COAGULATION FACTOR VIII
Concentration unit: IU/mg i
Sponsors
LFB BIOTECHNOLOGIES
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Patient who has provided written signed and dated informed consent prior to any study procedures - Previously-treated severe haemophilia A patients (basal level FVIII:C=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: - Present or past factor VIII inhibitor titre (defined as =0.6 Bethesda Units) - Platelets 5 times the upper limit of normal range - Current participation or in the last 3 months in another clinical study - Problematic venous access - Known hypersensitivity to any of the ingredients of FACTANE 200 IU/ml - CD4 lymphocytes < 400/mm3 - Any other condition that in the Investigator's opinion may interfere with the study results or would not be in the best interest of the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of FACTANE 200 IU/ml administered by continuous infusion for the perioperative and postoperative prophylaxis of bleeding during major surgical procedures in severe haemophilia A patients.;Secondary Objective: To evaluate the safety of FACTANE 200 IU/ml administered by continuous infusion.;Primary end point(s): Clinical efficacy Haemostasis rating based on the following scale: “excellent”, “good”, “moderate”, “none”. - excellent: similar haemostasis to that of a non bleeding disorder patient during the same surgery - good: slight oozing at surgical incision - moderate: mild, but controlled bleeding - none: severe, uncontrolled bleeding 'Responders' are patients who obtain a score of “excellent” or “good” on these 3 assessments.;Timepoint(s) of evaluation of this end point: The haemostasis rating will be performed by the surgeon on D0 (day of the surgery) and on day of drain tube removal (or on D2 if no drain) and by the Investigator on D7. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Daily clearance (CL) during the continuous infusion. - Blood loss and transfusion requirements. - IMP consumption: evolution of the infusion rate (IU/kg/h), total dose per surgery (IU/kg) and number of exposure days. - Safety: overall safety including adverse events, immunogenicity and local tolerability judged by the Investigator on Dn +30 (±3) according to the following scale: "excellent", "good", "moderate", "none".;Timepoint(s) of evaluation of this end point: For daily clearance, Blood loss and transfusion requirements, IMP consumption from D0 (day of the surgery) to Dn (end of the continuous infusion). For overall safety: during all the study | — |
Countries
Poland
Contacts
Public ContactCLINICAL TRIAL INFORMATION DESK
LFB BIOTECHNOLOGIES
Outcome results
None listed