PHARMACOKINETIC COMPARISON OF ADVATE rAHF-PFM WITH RECOMBINATE rAHF IN PATIENTS WITH SEVERE HEMOPHILIA A: A PHASE IV, PROSPECTIVE, RANDOMIZED, CONTROLLED, CROSS-OVER, SINGLE CENTER STUDY - Advate rAHF-PFM versus Recombinate rAHF

• Conditions: The objective of this study is to further evaluate observations of decreased efficacy in subjects having been switched to Advate rAHF-PFM from Recombinate rAHF by comparing the pharmacokinetic parameters of the two products in previously treated patients with severe hemophilia A (factor VIII level < 1%) in whom decreased efficacy with Advate rAHF-PFM compared to Recombinate rAHF was observed.; MedDRA version: 9.1Level: LLTClassification code 10066439Term: Hemophilia

• Registration Number: EUCTR2007-004834-18-DE
• Lead Sponsor: Baxter Innovations GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1.Signed informed consent obtained from subject or legally authorized representative
2. Age 15 - 60 years
3. Factor VIII level < 1% as documented by previously measured factor VIII and genotyping
4. Previously treated with factor VIII concentrate(s) for a minimum of at least 150 exposure days (as documented by the study site investigator) prior to study entry.
5. Observed decrease of efficacy by subject and/or treating physician after being switched from Recombinate rAHF to Advate rAHF-PFM.
Are the trial subjects under 18? yes
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. A detectable factor VIII inhibitor with a titer = 0.4 BU based on the patient charts.
2. The subject has a known hypersensitivity to mouse or hamster proteins or to either study product.
3. The subject is participating in another investigational drug study within 30 days prior to screening.
4. The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures.

Study & Design

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