Atenativ for Congenital Antithrombin Deficiency Surgery

Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery

Recruiting Phase 3 Interventional Study
Congenital Antithrombin Deficiency
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
12 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
38 (estimated)
Sponsor
Octapharma · Industry
Who this trial is looking for

This trial is looking for adults and certain teens with congenital antithrombin deficiency who are undergoing surgery or delivery. Participants will receive a treatment called Atenativ during their medical procedures.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with congenital antithrombin deficiency.
  • I have a personal or family history of blood clot events.
  • I am a non-pregnant surgical patient scheduled for elective surgery.
  • I am a pregnant patient of at least 27 weeks gestation scheduled for delivery.
  • I have provided informed consent.

You may not be able to join if

  • I need emergency surgery or an emergency cesarean section.
  • I have had surgery in the last 6 weeks.
  • I have another hereditary disorder that causes blood clots.
  • I have cancer, severe kidney failure, or severe liver disease.
  • My body mass index is over 40.
  • I am allergic to antithrombin or any ingredient in Atenativ.
  • I had a severe allergic reaction to blood products.
  • I have had a blood clot event in the last 6 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

The goal of this study is to assess the incidence of the composite of thrombotic events (TEs) and thromboembolic events (TEEs) in patients with congenital antithrombin deficiency under when they receive Atenativ for surgical procedures or parturition.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Adult male or female patients ≥18 and ≤80 years of age. Solely in the US, 4 male or female patients between ≥12 and \<17 years of age will be enrolled into the PK phase, and subsequently in the treatment phase, if applicable 2. Documented congenital antithrombin deficiency, d…
Contacts

Sigurd Knaub

+41554512141

Sigurd.Knaub@octapharma.com

CONTACT