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Study to Assess Recombinant Human Antithrombin in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery

Information source: GTC Biotherapeutics
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hereditary Antithrombin Deficiency

Intervention: Recombinant Human Antithrombin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GTC Biotherapeutics

Summary

Patients with hereditary antithrombin 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 efficacy of recombinant human antithrombin by infusing rh AT prior to, during and following the period of risk or surgical procedure.

Clinical Details

Official title: A Multicenter, Multinational Study to Assess the Incidence of Deep Vein Thrombosis (DVT) Following Prophylactic Intravenous Administration of Recombinant Human Antithrombin (rh AT) to Hereditary AT Deficient Patients in High-Risk Situations.

Study design: Prevention, Non-Randomized, Open Label, Efficacy Study

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Additional information on hereditary antithrombin disease

Starting date: December 2002
Last updated: January 30, 2007

Page last updated: June 20, 2008

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