Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation with special emphasis on hyperfibrinolysis

Study identification

• EU PAS number:
  EUPAS12164
• Study ID:
  34140
• Official title and acronym:
  Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation with special emphasis on hyperfibrinolysis
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This trial was terminated early after FDA released the requirements to conduct the trial. No meaningful results could be obtained based on the limited data obtained.
• Study status:
  Finalised

Research institutions and networks

Institutions

Octapharma

Multiple centres: 5 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 15/06/2015

Study start date

Actual: 16/11/2015

Date of final study report

Planned: 16/01/2020

Actual: 11/02/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Octapharma U.S.A. Inc.

Regulatory

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