OCTAPLEX in patients with acute major bleeding who are taking direct oral anticoagulant

• Research type

  Research Study

• Full title

  Study of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on direct oral anticoagulant (DOAC) therapy with factor Xa inhibitor.

• IRAS ID

  1004842

• Contact name

  Stephan Maack

• Contact email

  stephan.maack@octapharma.com

• Sponsor organisation

  Octapharma AG

• Eudract number

  2021-000740-21

• Clinicaltrials.gov Identifier

  NCT04867837

• Research summary

  Patients treated with anticoagulant drugs that act with direct effect against certain clotting factors and that can be taken orally, so called direct oral anticoagulant (DOAC), can suffer from acute major bleeding. The purpose of this study is to investigate whether the study medication can help control acute major bleeding in DOAC patients.
  The medication that is being tested in this study is called OCTAPLEX which is currently approved for use in the UK for the following indications:
  1. Treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required.
  2. Treatment of bleeding and perioperative prophylaxis in congenital deficiency of the vitamin K dependent coagulation factors II and X when purified specific coagulation factor product is not available.
  Approximately 200 male and female participants, aged 18 years or older will be enrolled from the UK, Europe and North America.
  The course of the study is approximately 30 days. Patients will be assigned randomly (like flipping a coin) to one of the following treatment doses: treatment with a single dose of OCTAPLEX low dose (15 IU/kg) or treatment with a single dose of OCTAPLEX high dose (50 IU/kg). The patient’s chances of getting into a particular treatment dose group are 50/50. This study is double blinded meaning neither the participants nor the study doctor will know which treatment dose group participants are assigned to. Eligible patients will be treated by infusion at the hospital. Following discharge, patients will receive three weekly follow up phone calls followed by a final follow up phone call 30 days after the end of the infusion.

• REC name

  HSC REC A

• REC reference

  22/NI/0077

• Date of REC Opinion

  27 May 2022

• REC opinion

  Further Information Favourable Opinion