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

Conditions

• Congenital Antithrombin Deficiency

Eligibility Criteria

Sex

ALL

Age

12 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Atenativ — DRUG
  Antithrombin concentrate

Study Details

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.

Key Dates

Start date

Jul 1, 2022

Status verified

Feb 2026

Primary completion

Dec 1, 2026

Completion

Dec 1, 2026

Study Design

Enrollment

38 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: Atenativ treatment
  During the PK phase, patients will receive a 60 IU/kg Atenativ as a single intravenous infusion for PK analysis. During the treatment phase, patients will receive a single intravenous loading dose followed by maintenance doses administered every 24 hours for approximately 2-7 days for surgical patients and approximately 5 days for parturients

Primary Outcome Measure

Thrombotic event incidence [ Time Frame: Up to day 30 post treatment initiation ]

Central Contacts

• Sigurd Knaub
  +41554512141
  [email protected]

Locations (5)

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