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

Prevention and treatment of bleeding in haemophilia A with Nuwiq®: Octanate®, Wilate®: A prospective, non-interventional study to evaluate prophylactic and on-demand treatment schedules and factor VIII requirement in routine clinical practice

Registry ID
ISRCTN57549638
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
Octapharma GmbH
Enrollment
200
Start date
2015-03-01
Completion date
2030-03-31
Last update
2026-08-17

Conditions

Summary

Haemophilia A

Detailed description

Current interventions as of 19/03/2024: NIS-Previq is a non-interventional study for which the routine treatment of haemophilia A patients on prophylaxis is documented. All treatments with Octanate®, Wilate®or Nuwiq®, any bleeding episode occuring or surgical procedures are carefully documented. Additionally, a joint score (HJHS) and/or a pharmacokinetic evaluation with individually calculated dosing schedules can be documented on an optional basis. Previous interventions: NIS-Previq is a non-interventional study for which the routine treatment of haemophilia A patients on prophylaxis is documented. All treatments with Nuwiq, any bleeding episode occuring or surgical procedures are carefully documented. Additionally, a joint score (HJHS), quality of life questionnaire (SF-36) and/or a pharmacokinetic evaluation with individually calculated dosing schedules can be documented on an optional basis.

Interventions

Inclusion criteria

Current inclusion criteria as of 11/06/2025: 1. The patient suffers from haemophilia A or reduced factor VIII levels with bleeding tendency 2. Treated with Octanate®, Wilate®or Nuwiq® 3. One of the following criteria is met: 3.1. The Patient receives prophylaxis with FVIII and a duration of 6 month is foreseen 3.2. The Patient is treated on demand with FVIII and treatment within the next 6 month is likely 3.3. The Patient receives prophylaxis with non-factor preparation and is in actual need of factor VIII treatment 4. Good compliance regarding documentation of FVIII treatments and bleeding episodes (in case home treatment is performed) _____ Previous 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

Locations

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