ATN-106

• Research type

  Research Study

• Full title

  A multicentre, prospective, open-label, uncontrolled Phase 3 study to assess the efficacy, safety and pharmacokinetics of Atenativ in patients with congenital antithrombin deficiency undergoing surgery or delivery

• IRAS ID

  1004451

• Contact name

  Cristina Solomon

• Contact email

  cristina.solomon@octapharma.com

• Sponsor organisation

  Octapharma AG

• Eudract number

  2021-004307-40

• Clinicaltrials.gov Identifier

  NCT04918173

• Research summary

  Multicentre, prospective, open-label, uncontrolled, Phase 3 study. The study will consist of two phases: a PK Phase to assess the PK of Atenativ following a single infusion in non-pregnant patients with congenital antithrombin deficiency, and a Treatment Phase to determine the efficacy and safety of Atenativ in a) elective surgical procedure known to be associated with a high risk for occurrence of TEs and TEEs in nonpregnant surgical patients and b) pregnant patients scheduled for caesarean section or delivery.
  Patients may participate in the PK Phase and/or the Treatment Phase in any order. Results will be collected from patients who perform either the PK Phase, the Treatment Phase, or both phases. Each patient may only participate in the Treatment Phase for one surgery or delivery.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  22/LO/0055

• Date of REC Opinion

  3 Mar 2022

• REC opinion

  Further Information Unfavourable Opinion