Non-interventional study for long term documentation of treatment with Vihuma in patients with hemophilia A (Biotest NIS-019)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33454
• EU PAS number:
  EUPAS18757
• Study ID:
  33454
• Official title and acronym:
  Non-interventional study for long term documentation of treatment with Vihuma in patients with hemophilia A (Biotest NIS-019)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Germany

  Switzerland
• Study description:
  The non-interventional Study has been cancelled due to the lack of participating sites and patient numbers at this time. No sites or patients have been recruited.Vihuma is a recombinant factor VIII (FVIII) produced in the human cell line HEK 293F (Human Embryonic Kidney Cells). Vihuma is approved for treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Vihuma can be used for all age groups. Details are given in the SPC and German Fachinformation of Vihuma.Hemophilia A is an inherited, chronic bleeding disorder and patients have to be treated lifelong with FVIII concentrates. Most children and adolescents are treated prophylactically in industrialized countries. Prophylaxis has the goal to avoid bleedings, in order to guarantee the patient a high quality of life (QoL).This will be the first NIS allowing direct comparison of treatment with a recombinant (Vihuma) and plasmatic factor VIII product (Haemoctin SDH, Biotest NIS-016), since data obtained in this two NIS are very similar.
• Study status:
  Finalised

Research institutions and networks

Institutions

Biotest

Multiple centres: 18 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 23/02/2017

Actual: 02/03/2017

Study start date

Planned: 02/01/2020

Actual: 31/12/2019

Data analysis start date

Planned: 30/06/2025

Actual: 31/12/2019

Date of final study report

Planned: 31/12/2025

Actual: 31/12/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biotest AG

Study protocol

Initial protocol

2017-04-12 FVIII recombinant NIS Observation Plan 1.0

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable