Phase 3B Recombinant Antihemophilic Factor Manufactured and Formulated without added Human or Animal Proteins (rAHF-PFM): Evaluation of Immunogenicity, Efficacy, and Safety in Previously Untreated Patients with Hemophilia A - PUP Study
Active, not recruiting
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10060612Term: Hemophilia A
- Registration Number
- EUCTR2004-001623-38-AT
- Lead Sponsor
- Baxter AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the immunogenicity of rAHF-PFM in previously untreated Hemophilia A patients?
How does rAHF-PFM compare to standard recombinant factor VIII therapies in PUPs for inhibitor development and bleeding control?
Which biomarkers correlate with inhibitor risk or treatment response in EUCTR2004-001623-38-AT Hemophilia A PUP study?
What adverse events are reported in rAHF-PFM trials for Hemophilia A, and how are inhibitor-related complications managed?
What are the therapeutic advantages of rAHF-PFM over plasma-derived or animal protein-containing factor VIII products in Hemophilia A management?