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

NCT ID: NCT00056550

Last Updated: 2012-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2004-02-29

Brief 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.

Detailed Description

Objectives :

1. Assess the safety of recombinant antithrombin (rhAT) in hereditary antithrombin (AT) deficient patients.

2. Assess the incidence of acute deep venous thrombosis(DVT) alone in patients with hereditary antithrombin (AT) deficiency in situations usually associated with a high risk for thromboembolic events after increasing and targeting functional AT activity at >80% and < 120% of normal by prophylactic IV administration of rhAT.

3. Clinically assess and determine the relevance of thromboembolic events other than acute DVT to rhAT administration.

Conditions

Antithrombin Deficiency, Congenital

Keywords

Antithrombin Deficiency, Congenital; Antithrombin III Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Recombinant Human Antithrombin (rhAT) infusion

Loading and continuous infusion dose of rhAT to target and maintain an AT activity level \> 80% and \< 120% of normal.

Group Type: EXPERIMENTAL

Recombinant Human Antithrombin (rhAT)

Intervention Type: BIOLOGICAL

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

Interventions

Recombinant Human Antithrombin (rhAT)

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

Intervention Type: BIOLOGICAL

Other Intervention Names

ATryn

Eligibility Criteria

Inclusion Criteria

• Have congenital AT deficiency with a personal or family history of venous thrombotic events.
• Have a history of congenital AT deficiency that includes 2 or more plasma AT activity levels of ≤ 60% normal.
• Are scheduled to have an elective procedure known to be associated with a high risk for occurrence of Deep Venous Thrombosis (DVT). This will include surgical patients or pregnant patients scheduled for cesarean section or delivery induction. In addition, hospitalized pregnant HD patients in active labor will be allowed into the study.
• Are at least 18 years of age, not exceeding 70 years of age.
• Have signed an informed consent form.
• Have a negative serum pregnancy test at screening and negative urine pregnancy test at baseline. This only applies to female surgical patients (not scheduled for cesarean section) of childbearing potential.
• Are able to comply with the requirements of the study protocol.

Exclusion Criteria

• Patients who have a diagnosis of hereditary APC resistance, Factor V Leiden, Protein S or C deficiency, prothrombin gene mutation (G20210A), or acquired (lupus anticoagulant) thrombophilic disorder.
• Patients who are scheduled for a neurosurgical procedure or open-heart surgery.
• Patients who have an underlying medical condition, which in the opinion of the investigator, could complicate the assessment of the incidence of DVT.
• Patients who have a known allergy to goats or goat products.
• Patients who have participated in a study employing an investigational drug within 30 days of the start of their participation in the current trial.
• Patients using fondaparinux sodium, or are expected to be treated with fondaparinux sodium during the study period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

rEVO Biologics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cambell Tait, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Infirmary Glaskow

Locations

Marietta, Georgia, United States

Charleston, South Carolina, United States

Paris, , France

Toulouse, , France

Berlin, , Germany

Hanover, , Germany

Mannheim, , Germany

Milan, , Italy

Stockholm, , Sweden

Bristol, , United Kingdom

Manchester, , United Kingdom

Countries

United States; France; Germany; Italy; Sweden; United Kingdom

References

DeJongh J, Frieling J, Lowry S, Drenth HJ. Pharmacokinetics of recombinant human antithrombin in delivery and surgery patients with hereditary antithrombin deficiency. Clin Appl Thromb Hemost. 2014 May;20(4):355-64. doi: 10.1177/1076029613516188. Epub 2013 Dec 11.

Reference Type: DERIVED

PMID: 24335249 (View on PubMed)

Related Links

http://www.atiii.com

Additional information on hereditary antithrombin disease

Other Identifiers

GTC AT III 01002

Identifier Type: -

Identifier Source: org_study_id