Non-interventional study (NIS) for long-term monitoring of the treatment of hemophilia A with Haemoctin SDH (Haemoctin NIS)

Study identification

• EU PAS number:
  EUPAS8063
• Study ID:
  25885
• Official title and acronym:
  Non-interventional study (NIS) for long-term monitoring of the treatment of hemophilia A with Haemoctin SDH (Haemoctin NIS)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Hungary
• Study description:
  With the present NIS data on effectiveness, tolerability and safety of the drug in the long-term treatment under real life conditions will be documented.The following questions should be considered:What impact has a treatment with Haemoctin over many years to decades on the health of patients?Can the risk of bleeding for years to be effectively reduced?What is the risk for inhibitor formation during treatment with Haemoctin SDH in previous treated and untreated patients?A signal from pharmacovigilance, which would make this investigation mandatory, is not evident.
• Study status:
  Finalised

Research institutions and networks

Institutions

Dr. Christoph Königs

Multiple centres: 20 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual:01/05/1998

Study start date

Actual:29/05/1998

Data analysis start date

Planned:01/07/2016

Date of interim report, if expected

Actual:30/07/2010

Date of final study report

Planned:31/12/2016

Actual:13/04/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biotest AG

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only