241302: POST-MARKETING non-interventional safety evaluation of obizur in the treatment of bleeding episodes for patients with acquired hemophilia A (241302: US Post-Marketing Safety Study)

Study identification

• EU PAS number:
  EUPAS36659
• Study ID:
  43028
• Official title and acronym:
  241302: POST-MARKETING non-interventional safety evaluation of obizur in the treatment of bleeding episodes for patients with acquired hemophilia A (241302: US Post-Marketing Safety Study)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The overall objective is to enroll patients with acquired hemophilia A (AHA) who are prescribed and treated with Obizur, to assess safety, and to describe factors related to safety, utilization and effectiveness in a real-world setting.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Multiple centres: 18 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual:29/10/2015

Study start date

Actual:30/12/2015

Data analysis start date

Actual:07/06/2019

Date of final study report

Actual:22/06/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Baxalta Innovations GmbH, now part of Takeda and Baxalta US Inc.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

NCT02610127,https://clinicaltrials.gov/ct2/show/NCT02610127?term=NCT02610127&draw=2&rank=1