A Double-Blind, Randomized, Crossover Study of the Recovery of FACTANE 100 versus 200 IU/ml followed by an Open-Label Safety Study of FACTANE 200 IU/ml in Previously Treated Patients With Severe (FVIII:C<1%) Haemophilia A

Phase 1

• Conditions: Haemophilia A; MedDRA version: 9.1Level: LLTClassification code 10060612Term: Hemophilia A

• Registration Number: EUCTR2009-013227-28-FR
• Lead Sponsor: FB BIOTECHNOLOGIES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-05
• Study Completion: 2010-11-25
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 13

Inclusion Criteria

1.Severe haemophilia A patients (basal levels FVIII:C <1 IU/dl).
2.Male patient older than 18 years.
3.Patient usually treated with FACTANE 100 IU/ml.
4.Patient anticipated to be treated with 9 injections of FACTANE 200 IU/ml within the 3 months following the recovery study.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified