MedTrace Logo

Assess Incidence of Deep Vein Thrombosis(DVT)Following Administration of Recombinant Human Antithrombin (rhAT) to Hereditary Antithrombin(AT) Deficient Patients in High Risk Situations.

NCT00056550 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2012-10-16

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Antithrombin Deficiency, Congenital

Interventions

BIOLOGICAL

Recombinant Human Antithrombin (rhAT)

Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial.

Sponsors & Collaborators

  • rEVO Biologics

    lead INDUSTRY

Principal Investigators

  • Cambell Tait, MD · Royal Infirmary Glaskow

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2004-02-29
Completion
2004-02-29

Countries

  • United States
  • France
  • Germany
  • Italy
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00056550 on ClinicalTrials.gov