Non-interventional study of long term treatment with Haemoctin SDH (Biotest NIS-016)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27437
• EU PAS number:
  EUPAS13728
• Study ID:
  27437
• Official title and acronym:
  Non-interventional study of long term treatment with Haemoctin SDH (Biotest NIS-016)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Germany

  Hungary
• Study description:
  Haemoctin SDH is a factor VIII (FVIII) preparation derived from human plasma purified by chromatography. Haemoctin SDH is approved for prevention and treatment of innate and acquired factor VIII deficiencies. Also, patients with a FVIII inhibitor can be treated with Haemoctin SDH. Details are given in the SPC of Haemoctin SDH. The stabilization of the FVIII molecule is carried out by the natural carrier protein von Willebrand factor. There is no need for the addition of auxiliary stabilizers such as sucrose or human serum albumin. 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). Patients who have started in childhood with the prophylaxis, this treatment is extended in adulthood. Prophylactic treatment consists of regular FVIII applications, usually three times a week. With this study long-term data will be generated. Unique longterm data obtained form some patients in a previous study with Haemoctin SDH over up to 22 year can be extended with this study. This NIS allows adopting the documentation to the current guidance for observational studies and adjusted focus of the objectives.
• Study status:
  Finalised

Research institutions and networks

Institutions

Biotest

Study timelines

Date when funding contract was signed

Planned: 01/02/2016

Actual: 12/04/2016

Study start date

Planned: 01/03/2016

Actual: 01/06/2016

Data analysis start date

Planned: 31/12/2021

Actual: 01/01/2023

Date of final study report

Planned: 30/09/2023

Actual: 08/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biotest AG

Study protocol

Initial protocol

2021-02-18 Haemoctin NIS Observation Plan_V2 clean

Regulatory

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