Who is sponsoring NCT00110513?

NCT00110513 is sponsored by rEVO Biologics.

What drugs are being tested in NCT00110513?

Interventions in NCT00110513: Recombinant human antithrombin (rhAT).

What condition does NCT00110513 study?

NCT00110513 studies Antithrombin III Deficiency.

Is NCT00110513 still recruiting?

NCT00110513 is currently completed. Last updated 10 August 2012.

Are results published for NCT00110513?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2012-08-10 · How we verify

NCT00110513

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multicenter, Multinational Study to Assess the Safety and Efficacy of Antithrombin Alfa in Hereditary Antithrombin (AT) Deficient Patients in High-Risk Situations for Thrombosis

Completed Phase 3 Results posted Last updated 10 August 2012

What this trial tests

Phase 3 trial testing Recombinant human antithrombin (rhAT) in Antithrombin III Deficiency in 18 participants. Completed in 1 July 2008.

Timeline

1 April 2005

Primary endpoint
1 May 2008

1 July 2008

Quick facts

Lead sponsor	rEVO Biologics
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	18
Start date	1 April 2005
Primary completion	1 May 2008
Estimated completion	1 July 2008
Sites	17 locations across United States, Australia, Austria, Canada, France, Germany, Italy, United Kingdom

Drugs / interventions tested

Recombinant human antithrombin (rhAT) — full drug profile →

Conditions studied

Antithrombin III Deficiency — all drugs for Antithrombin III Deficiency →

Sponsor

rEVO Biologics — full company profile →

Who can join

Adults 18 to 80, any sex, with Antithrombin III Deficiency. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Venous Thrombosis (DVT)
Time frame: During treatment and follow up period of 7 days
To assess the incidence of thromboembolic events acute deep venous thrombosis (DVT) and/or thromboembolic events other than acute deep venous thrombosis (DVT) by clinical signs and symptoms of venous thromboembolism (VTE), confirmed by diagnostic assessments.

Sponsor's own description

Patients with hereditary antithrombin deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial focused on patients with confirmed hereditary antithrombin deficiency who were undergoing a surgical procedure or induced/spontaneous labor and delivery, and/or caesarean section. The study assessed the incidence of thromboembolic events following prophylactic intravenous administration of recombinant human antithrombin (rhAT) to patients with hereditary antithrombin (AT) deficiency in situations usually associated with a high risk for thromboembolic events.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00110513 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by rEVO Biologics
Last refreshed: 10 August 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00110513.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing