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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-004834-18-DE
Enrollment
Unknown
Registered
2007-11-30
Start date
2008-02-22
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 9.1 Level: LLT Classification code 10066439 Term: Hemophilia

Interventions

Trade Name: Advate Product Name: Advate Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: Octocog alfa Other descriptive name: recombinant coagulation factor VI

Sponsors

Baxter Innovations GmbH
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1.Signed informed consent obtained from subject or legally authorized representative 2. Age 15 - 60 years 3. Factor VIII level =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate observations of decreased efficacy in subjects having been switched to Advate rAHF-PFM from RecombinaterAHF 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;Secondary Objective: To assess study drug related adverse experiences;Primary end point(s): Area under the plasma concentration vs. time curve from 0 to 48 hours (AUC0-48h) Total area under the plasma concentration vs. time curve Plasma half-life (t1/2) Cmax Tmax Incremental recovery Clearance (CL) Mean residence time (MRT) Volume of distribution at steady state (Vss)—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026