A STUDY ON FACTOR VIII CONCENTRATE USED BY CONTINUOUS INFUSION IN PATIENTS WITH INHERITED FACTOR VIII DEFICIENCY DURING SURGERY

• Register: EUCTR
• Last refreshed on: 22 October 2012
• Main ID: EUCTR2010-023666-46-PL
• Date of registration: 20/12/2011
• Prospective Registration: No
• Primary sponsor: LFB BIOTECHNOLOGIES
• Public title: A STUDY ON FACTOR VIII CONCENTRATE USED BY CONTINUOUS INFUSION IN PATIENTS WITH INHERITED FACTOR VIII DEFICIENCY DURING SURGERY
• Scientific title: EFFICACY AND SAFETY STUDY OF FACTANE 200 IU/ml ADMINISTERED BY CONTINUOUS INFUSION IN SEVERE HAEMOPHILIA A PATIENTS DURING MAJOR SURGICAL PROCEDURES
• Date of first enrolment: 13/12/2011
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023666-46
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Poland

Contacts

• Name: CLINICAL TRIAL INFORMATION DESK
• Affiliation: LFB BIOTECHNOLOGIES

• Name: CLINICAL TRIAL INFORMATION DESK
• Affiliation: LFB BIOTECHNOLOGIES

Key inclusion & exclusion 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<1 IU/dl)
- Male patient older than 18 years
- Patient scheduled for an elective major surgery
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion criteria:
- Present or past factor VIII inhibitor titre (defined as =0.6 Bethesda Units)
- Platelets <100 x 109/l
- Medication with interferon / ribavirin or protease inhibitors
- AST and ALT > 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


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

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

Intervention(s)

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 international unit(s)/milligram
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

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.

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.

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.

Secondary Objective: To evaluate the safety of FACTANE 200 IU/ml administered by continuous infusion.

Secondary Outcome(s)

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

Secondary ID(s)

F8VR-1006

Source(s) of Monetary Support

LFB BIOTECHNOLOGIES