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NCT00056550: rhAT
A Study to Assess the Incidence of Deep Vein Thrombosis (DVT) Following Prophylactic Intravenous Administration of Recombinant Human Antithrombin(rhAT) to Hereditary Antithrombin (AT) Deficient Patients in High Risk Situations.
Phase 3 trial testing Recombinant Human Antithrombin (rhAT) in Antithrombin Deficiency, Congenital in 14 participants. Completed in 1 February 2004.
1 February 2004
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 | 14 |
| Start date | 1 December 2002 |
| Primary completion | 1 February 2004 |
| Estimated completion | 1 February 2004 |
| Sites | 11 locations across United States, France, Germany, Italy, Sweden, United Kingdom |
Drugs / interventions tested
- Recombinant Human Antithrombin (rhAT) — full drug profile →
Conditions studied
- Antithrombin Deficiency, Congenital — all drugs for Antithrombin Deficiency, Congenital →
Sponsor
rEVO Biologics — full company profile →
Who can join
Adults 18 to 70, any sex, with Antithrombin Deficiency, Congenital. 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 Vein Thrombosis (DVT).
Time frame: Baseline, last day of dosing and day 7 (+ or - 1 day)
Observation for clinical signs and symptoms of thromboembolic events are evaluated for acute deep vein thrombosis (DVT) using duplex ultrasonography and/or other imaging tests to confirm clinical signs/symptoms. Duplex ultrasonography was performed at baseline, last day of dosing and day 7 (+ or -1 day).
Sponsor's own description
Patients with hereditary antithrombin (AT) deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial is focusing on patients with confirmed hereditary antithrombin deficiency who are undergoing a surgical procedure or induced/spontaneous labor and delivery. The study will test the safety and efficacy of recombinant human antithrombin (rhAT) by infusing rhAT prior to, during and following the period of risk or surgical procedure.
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:
- PubMed search for NCT00056550
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00056550 (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: 17 September 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/NCT00056550.
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