NCT04918173 Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery
| NCT ID | NCT04918173 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Octapharma |
| Condition | Congenital Antithrombin Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 38 participants in total. It began in 2022-07-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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, defined by plasma activity level of antithrombin ≤60% from medical history 3. Personal or family history of TEs or TEEs (except for PK patients) 4. For the Treatment Phase: either a) non-pregnant surgical patients scheduled for elective surgical procedure(s) known to be associated with a high risk for occurrence of TEs or TEEs, or b) pregnant patients of at least 27 weeks gestational age who are scheduled for caesarean section or delivery 5. For female patients of childbearing potential entering the PK Phase who are not known to be pregnant, and for female surgical patients of childbearing potential entering the Treatment Phase for any procedure other than caesarean section or delivery, a negative urine pregnancy test at screening and at baseline 6. Patient has provided informed consent Exclusion Criteria: 1. Requires emergency surgery or emergency caesarean section 2. Has undergone surgery within the last 6 weeks 3. History or suspicion of another hereditary thrombophilic disorder other than antithrombin deficiency (e.g., activated protein C \[APC\] resistance/Factor V Leiden, Protein S or C deficiency, prothrombin gene mutation \[G20210A\], or acquired \[lupus anticoagulant\] thrombophilic disorder) 4. Malignancies, renal failure (patients on renal replacement therapy), or severe liver disease (aspartate aminotransferase \[ASAT\] \>5 times the upper limit of normal) 5. Body mass index \>40 kg/m2 (for non-pregnant patients, only) 6. Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ 7. History of anaphylactic reaction(s) to blood or blood components 8. Refusal to receive transfusion of blood-derived products 9. Administration of any antithrombin concentrate or antithrombin-containing blood product within 14 days of either of the two phases of the study 10. Prior diagnosis of heparin-induced thrombocytopenia 11. TE or TEE within the last 6 months 12. Female patients who are nursing at the time of screening\* 13. Have participated in another investigational study within the last 30 days 14. Persons dependent on the sponsor, the investigator or the centre of investigation 15. Persons placed in an institution by administrative or judicial order * criterion does not include female patients who plan to breastfeed after giving birth
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04918173 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 80 Years, studying Congenital Antithrombin Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04918173 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 38 participants.
Is NCT04918173 currently recruiting?
Yes, NCT04918173 is actively recruiting participants. Contact the research team at Sigurd.Knaub@octapharma.com for enrollment information.
Where is the NCT04918173 trial being conducted?
This trial is being conducted at Washington D.C., United States, Miami, United States, Peoria, United States, New York, United States and 11 additional locations.
Who is sponsoring the NCT04918173 clinical trial?
NCT04918173 is sponsored by Octapharma. The trial plans to enroll 38 participants.