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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-001623-38-AT
Enrollment
55
Registered
2004-10-01
Start date
2004-11-05
Completion date
Unknown
Last updated
2013-04-22

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

Conditions

MedDRA version: 9.1 Level: LLT Classification code 10060612 Term: Hemophilia A

Interventions

Pharmaceutical Form:

Sponsors

Baxter AG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Austria

Outcome results

None listed

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