ADVATE / ADYNOVI Hemophilia A Outcome Database

• Conditions: D66; Hereditary factor VIII deficiency

• Registration Number: DRKS00000556
• Lead Sponsor: Takeda Pharma Vertrieb GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-23
• Study Completion: 2022-03-31
• Results First Posted: 2023-04-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 406

Inclusion Criteria

Subject has moderate or severe hemophilia A (baseline factor VIII < 5%) and is being treated with ADVATE or ADYNOVI on any treatment regimen recommended by his/her treating physician. Subject, parent(s) or legally authorized representative has provided written informed consent. For ADYNOVI: Subject aged = 12 years

Exclusion Criteria

Subject has known hypersensitivity to the active substance or to any of the excipients. Subject has a known allergic reaction to mouse or hamster proteins.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of haemophilia-affected joint-arthropathy by imaging techniques (e.g. MRI, X-ray, ultrasound) and by assessment of the treating physician using only the pain, bleeding, and physical exam parameter of the Gilbert Scale.