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Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass

O

Octapharma

Status and phase

Enrolling
Phase 3

Conditions

Acquired Antithrombin Deficiency

Treatments

Drug: Placebo
Drug: Human plasma derived antithrombin

Study type

Interventional

Funder types

Industry

Identifiers

NCT06096116
ATN-108

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)

Enrollment

120 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Planned cardiac surgery with CPB
  2. Heparin-resistant patients (pre-CPB Hemochron ACT less than 480 s in the measurement taken between 2-5 minutes following intravenous administration of 500 U/kg UFH)
  3. Patients between 18 and 85 years of age, inclusive
  4. Freely given written or electronic informed consent
  5. In female patients of childbearing potential, a pre-existing negative pregnancy test within 14 days prior to surgery

Exclusion criteria

  1. Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery:

    1. warfarin (within 3 days)
    2. direct oral anticoagulants (within 2 days)
    3. ticlopidine (within 14 days)
    4. prasugrel (within 7 days)
    5. clopidogrel (within 5 days)
    6. ticagrelor (within 5 days)
    7. glycoprotein IIb/IIIa antagonist (within 1 day)
  2. Pre-existing coagulopathy, a history of bleeding problems, a history of bleeding problems, or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder)

  3. Renal insufficiency, defined as serum creatinine level >1.5 mg/dL

  4. Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ i.e., human albumin, sodium chloride, acetyl tryptophan, caprylic acid

  5. History of anaphylactic reaction(s) to blood or blood components

  6. Refusal to receive transfusion of blood or blood-derived products

  7. Current participation in another interventional clinical trial or previous participation in the current trial

  8. Treatment with any IMP within 30 days prior to screening visit

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 participants in 3 patient groups, including a placebo group

Low-dose Atenativ
Experimental group
Treatment:
Drug: Human plasma derived antithrombin
High-dose Atenativ
Experimental group
Treatment:
Drug: Human plasma derived antithrombin
Placebo
Placebo Comparator group
Description:
Patients will receive a saline bolus dose
Treatment:
Drug: Placebo

Trial contacts and locations

5

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Central trial contact

Sigurd Knaub, PhD

Data sourced from clinicaltrials.gov

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