Atenativ (human antithrombin III) / Octapharma - LARVOL DELTA

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 (clinicaltrials.gov) - P3 | N=120 | Recruiting | Sponsor: Octapharma | Trial completion date: Sep 2026 ➔ Dec 2026 | Trial primary completion date: Sep 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Cardiovascular

Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Cardiac Surgery Patients: Protocol Update for an Ongoing Phase 3, Double-Blind, Placebo-Controlled, Multicenter Study (ASH 2024) - P3 | "Exclusion criteria include patients receiving anticoagulant therapies (warfarin, direct oral anticoagulants, ticlopidine, prasugrel, clopidogrel, ticagrelor or a glycoprotein IIb/IIIa antagonist) directly before the study, pre-existing coagulopathy, renal insufficiency (serum creatinine level >1.5 mg/dL), a history of bleeding problems or a laboratory-diagnosed bleeding disorder. Target enrollment is ~120 patients. The findings of this study could confirm the efficacy and safety of AT concentrate in re-establishing and maintaining heparin responsiveness for acquired AT deficiency in patients undergoing CPB."

Clinical • P3 data • Surgery • Cardiovascular • Hematological Disorders • Nephrology • Renal Disease • Thrombosis

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 (clinicaltrials.gov) - P3 | N=120 | Recruiting | Sponsor: Octapharma | Not yet recruiting ➔ Recruiting

Enrollment open • Surgery • Cardiovascular

ATN-106: Efficacy of Atenativ in Patients with Congenital Antithrombin Deficiency Undergoing Surgery or Delivery (clinicaltrials.gov) - P3 | N=38 | Recruiting | Sponsor: Octapharma | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Surgery • Trial completion date • Trial primary completion date

ATN-106: Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery (clinicaltrials.gov) - P3 | N=38 | Recruiting | Sponsor: Octapharma | Trial completion date: Dec 2024 ➔ Jun 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Surgery • Trial completion date • Trial primary completion date

The efficacy and safety of human plasma-derived antithrombin in heparin-resistant cardiac surgery patients: a double-blind, placebo-controlled, multicentre study (ATN-108) (Euroanaesthesia 2024) - "The ATN-108 study aims to evaluate the efficacy of two doses of antithrombin concentrate (Atenativ, Octapharma) versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating CPB...Exclusion criteria include patients who have received anticoagulant therapies (i.e., warfarin, direct oral anticoagulants, ticlopidine, prasugrel, clopidogrel, ticagrelor or a glycoprotein IIb/IIIa antagonist) directly prior to the study, and patients with pre-existing coagulopathy or renal insufficiency (serum creatinine level >1.5 mg/dL)...Anticipated completion is in Q3 2026. Conclusion(s): Results could confirm the efficacy and safety of antithrombin concentrate in restoring and maintaining heparin responsiveness in patients undergoing CPB."

Clinical • Surgery • Cardiovascular • Hematological Disorders • Nephrology • Renal Disease

A PHASE 3, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF HUMAN PLASMA DERIVED ANTITHROMBIN (ATENATIV) IN HEPARIN-RESISTANT CARDIAC SURGERY PATIENTS (THSNA 2024) - "Exclusion criteria include patients who have received anticoagulant therapies directly prior to the study, including warfarin, direct oral anticoagulants, ticlopidine, prasugrel, clopidogrel, ticagrelor or a glycoprotein IIb/IIIa antagonist. The study findings could confirm the efficacy and safety of antithrombin concentrate in re-establishing and maintaining heparin responsiveness in patients undergoing CPB."

Clinical • P3 data • Surgery • Allergy • Cardiovascular • Hematological Disorders • Immunology • Nephrology • Renal Disease • Thrombosis

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 (clinicaltrials.gov) - P3 | N=120 | Not yet recruiting | Sponsor: Octapharma

New P3 trial • Surgery • Cardiovascular

Prospective, Phase III Study of the Efficacy, Safety, and Pharmacokinetics of a Human Antithrombin III Concentrate in Congenital Antithrombin Deficiency During Surgery or Childbirth (ISTH 2023) - P3 | "To date, two patients have been enrolled, in the US. Study completion is expected in Q3 2024.Conclusion(s): The results from this pivotal registration study are expected to strengthen the available evidence indicating that human plasma-derived antithrombin concentrate effectively prevents thrombotic and thromboembolic events in patients with congenital antithrombin deficiency in surgery and delivery settings and has a favorable safety profile."

Clinical • P3 data • PK/PD data • Surgery • Cardiovascular • Genetic Disorders

Atenativ, a Plasma-Derived Antithrombin Concentrate, Used in Patients with Congenital Antithrombin Deficiency Undergoing Surgery or Parturition: Study Description (NCT04918173) (ASH 2022) - P3 | "This study will endeavor to determine and decrease the incidence of thrombotic and thromboembolic events in subjects with congenital antithrombin deficiency during high-risk periods."

Clinical • Cardiovascular • Hematological Disorders • Thrombocytopenia • Thrombosis

Prospective, Phase III Study of the Efficacy, Safety, and Pharmacokinetics of a Human Antithrombin III Concentrate in Congenital Antithrombin Deficiency during Surgery or Childbirth (ASH 2021) - P3 | "This study will aim to evaluate the efficacy, safety, and pharmacokinetics (PK) of a high-purity, double virus inactivated, lyophilized human antithrombin III concentrate (Atenativ ® ) in these settings... The results from this pivotal registration study are expected to confirm and strengthen the available evidence indicating that human plasma-derived antithrombin concentrate is effective in preventing thrombotic and thromboembolic events in patients with CAD in surgery and delivery settings and has a favorable safety profile."

Clinical • P3 data • PK/PD data • Cardiovascular • Hematological Disorders

Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection (clinicaltrials.gov) - P=N/A | N=300 | Completed | Sponsor: Octapharma | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection (clinicaltrials.gov) - P=N/A | N=300 | Active, not recruiting | Sponsor: Octapharma | Trial completion date: Jun 2022 ➔ Oct 2022 | Trial primary completion date: Jun 2022 ➔ Oct 2022

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

ATN-106: Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery (clinicaltrials.gov) - P3 | N=38 | Recruiting | Sponsor: Octapharma | Not yet recruiting ➔ Recruiting

Enrollment open

Prospective, Phase III Study of the Efficacy, Safety, and Pharmacokinetics of a Human Antithrombin III Concentrate in Congenital Antithrombin Deficiency During Surgery or Childbirth (ISTH 2022) - P3 | "Aims: To evaluate the efficacy, safety, and pharmacokinetics (PK) of a high-purity, double virus inactivated, lyophilized human antithrombin III concentrate (Atenativ®) in patients with CAD undergoing surgery or delivery... Enrollment is estimated to start in Q1 2022 and end in Q3 2024. Conclusion(s): The results from this pivotal registration study are expected to confirm and strengthen available evidence indicating that human plasma-derived antithrombin concentrate is effective in preventing TEs and TEEs in patients with CAD in surgery and delivery, with a favorable safety profile."

Clinical • P3 data • PK/PD data • Cardiovascular • Hematological Disorders

ATN-106: Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery (clinicaltrials.gov) - P3 | N=34 | Not yet recruiting | Sponsor: Octapharma | Initiation date: Oct 2021 ➔ Mar 2022

Trial initiation date

Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery (clinicaltrialsregister.eu) - P3 | N=34 | Ongoing | Sponsor: Octapharma AG

New P3 trial

Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection (clinicaltrials.gov) - P=N/A | N=300 | Active, not recruiting | Sponsor: Octapharma | Trial completion date: Dec 2021 ➔ Apr 2022 | Trial primary completion date: Dec 2021 ➔ Apr 2022

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection (clinicaltrials.gov) - P=N/A; N=300; Active, not recruiting; Sponsor: Octapharma; Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease

Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery (clinicaltrials.gov) - P3; N=34; Not yet recruiting; Sponsor: Octapharma; Trial completion date: Jul 2024 ➔ Dec 2024; Trial primary completion date: Jul 2024 ➔ Dec 2024

Clinical • Trial completion date • Trial primary completion date

Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection (clinicaltrials.gov) - P=N/A; N=300; Recruiting; Sponsor: Octapharma; Trial completion date: Jun 2021 ➔ Dec 2021; Trial primary completion date: Jun 2021 ➔ Dec 2021

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease