Prevention of bleeding in haemophilia A by prophylactic treatment with Nuwiq® .

Not Applicable

• Conditions: Haemophilia A; Haematological Disorders

• Registration Number: ISRCTN57549638
• Lead Sponsor: Octapharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-23
• Last Update Posted: 1 April 2024
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Current inclusion criteria as of 19/03/2024:
1. Haemophilia A
2. Treated with Octanate®, Wilate®or Nuwiq®
3. Prophylactic treatment schedule for at least 6 months is to be expected
4. Good compliance regarding documentation of FVIII treatments and bleeding episodes (in case home treatment is performed)

Previous inclusion criteria:
1. Haemophilia A
2. Treated with Nuwiq
3. Prophylactic treatment schedule for at least 6 months is to be expected
4. Good compliance regarding documentation of FVIII treatments and bleeding episodes (in case home treatment is performed)

Exclusion Criteria

Patients with known contraindications as specified in the SPC

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 19/03/2024:<br>Annual bleeding rate (ABR) during prophylaxis with Octanate®, Wilate® or Nuwiq® and ABR by weekly Nuwiq doses (IU/kg)<br><br>Previous primary outcome measure:<br>Annual bleeding rate (ABR) during prophylaxis with Nuwiq and ABR by weekly Nuwiq doses (IU/kg)