Haemophilia A Haematological Disorders Haemophilia A
Conditions
Interventions
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®,
Sponsors
Octapharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Patients with known contraindications as specified in the SPC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 19/03/2024: Annual bleeding rate (ABR) during prophylaxis with Octanate®, Wilate® or Nuwiq® and ABR by weekly Nuwiq doses (IU/kg) Previous primary outcome measure: Annual bleeding rate (ABR) during prophylaxis with Nuwiq and ABR by weekly Nuwiq doses (IU/kg) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 19/03/2024: 1. Frequency distribution of the infusion intervals used – e.g. once, twice, thrice weekly or more frequently. 1.1. FVIII Dose/kg body weight per injection 1.2. Weekly FVIII Dose/kg body weight 2. Changes in HJHS Score results over time and after PK-based adjustments of prophylactic schedule. 3. Efficacy assessments for treatment of bleeding episodes according to a 4-point verbal rating scale 4. ADR rates per infusion and per patient Previous secondary outcome measures: 1. Frequency distribution of the infusion intervals used – e.g. once, twice, thrice weekly or more frequently. 1.1. FVIII Dose/kg body weight per injection 1.2. Weekly FVIII Dose/kg body weight 2. Changes in SF-36 results over time and after PK-based adjustments of prophylactic schedule. 3. Changes in HJHS Score results over time and after PK-based adjustments of prophylactic schedule. 4 . Efficacy assessments for treatment of bleeding episodes according to a 4-point verbal rating scale 5. ADR rates per infusion and per patient | — |
Countries
Germany
Outcome results
None listed