Trials Sponsors Conditions Drugs Pricing

Conditions

Congenital antithrombin deficiency Congenital Antithrombin Deficiency

Outcome Measures

Primary Outcomes (1)

Thrombotic event incidence
The primary objective of this study is to assess the incidence of the composite of TEs and TEEs in patients with congenital antithrombin deficiency under cover of Atenativ for surgical procedures or parturition
Up to day 30 post treatment initiation

Secondary Outcomes (13)

Single dose Pharmacokinetics of Atenativ: Area under the curve (AUCnorm(0-∞))
Up to day 14 post PK infusion
Single dose Pharmacokinetics of Atenativ: Maximum plasma concentration (Cmax)
Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion
Single dose Pharmacokinetics of Atenativ: Half-life (t1/2)
Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion
Single dose Pharmacokinetics of Atenativ: Mean residence time (MRT)
Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion
Single dose Pharmacokinetics of Atenativ: Clearance (CL)
Before first infusion, 20 minutes, 1 hour, 3 hours, 8 hrs, 1 day, 2 days, 3, days, 4 days, 5 days, 6 days, 7 days, 8 days, 10 days, 12 days and 14 days post-infusion

Study Arms (1)

Atenativ treatment

EXPERIMENTAL

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

Drug: Atenativ

Interventions

AtenativDrug

Antithrombin concentrate

Atenativ treatment

Atenativ 50 NE/ml por és oldószer oldatos infúzióhoz vagy injekcióhozType not reported

Atenativ 1000 UI/20 ml polvere e solvente per soluzione per infusione endovenosa

Eligibility Criteria

Age12 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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
Documented congenital antithrombin deficiency, defined by plasma activity level of antithrombin ≤60% from medical history

Sponsors & Collaborators

Octapharma AG
Industrylead
Octapharma
Industrylead

Study Sites (30)

Georgetown University Hospital

Washington D.C., District of Columbia, 20057, United States

RECRUITING

University of Miami, Miller School of Medicine

Miami, Florida, 33124, United States

RECRUITING

Bleeding and Clotting Disorders Institute

Peoria, Illinois, 61615, United States

RECRUITING

Weill Cornell Medicine, New York Presbyterian Hospital

MeSH Terms

Interventions

Antithrombin III

Intervention Hierarchy (Ancestors)

Antithrombin ProteinsSerpinsPeptidesAmino Acids, Peptides, and ProteinsAlpha-GlobulinsSerum GlobulinsBlood ProteinsProteinsGlobulinsBlood Coagulation Factor InhibitorsBiological Factors

Central Study Contacts

Sigurd Knaub

CONTACT

+41554512141 Sigurd.Knaub@octapharma.com

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NA
Masking: NONE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 18, 2021

First Posted

June 8, 2021

Study Start

July 1, 2022

Actual (reported)

Primary Completion

December 1, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (1)

Atenativ treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (30)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (1)

Atenativ treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (30)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations