Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GTC Biotherapeutics

ClinicalTrials.gov Identifier:

NCT00110513

First received: May 10, 2005

Last updated: August 10, 2012

Last verified: August 2012

History of Changes

Results First Received: March 19, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Antithrombin III Deficiency
Intervention:	Biological: Recombinant human antithrombin (rhAT)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study population included non pregnant patients who were scheduled for surgery and pregnant patients who were scheduled for caesarean section or delivery induction or were hospitalized in active labor.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eighteen patients were treated with recombinant human antithrombin (rhAT) and analyzed for safety.

Reporting Groups

	Description
Recombinant Human Antithrombin (rhAT) Infusion	Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.

Participant Flow: Overall Study

	Recombinant Human Antithrombin (rhAT) Infusion
STARTED	18
COMPLETED	18
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Recombinant Human Antithrombin (rhAT) Infusion	Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.

Baseline Measures

	Recombinant Human Antithrombin (rhAT) Infusion
Number of Participants [units: participants]	18
Age [units: participants]
<=18 years	0
Between 18 and 65 years	18
>=65 years	0
Age [units: years] Mean ± Standard Deviation	37.2 ± 12.2
Gender [units: participants]
Female	14
Male	4
Region of Enrollment [units: participants]
France	3
Canada	2
Australia	1
Germany	1
United Kingdom	8
Italy	1
United States	2
Prior history of thromboembolism [units: Participants]	18
Antithrombin (AT) activity level <60% [units: Participants]	18

Outcome Measures

1. Primary:

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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Denise Tilton, RN, MHA, Director Clinical Affairs
Organization: GTC Biotherapeutics
phone: 508-370-5257
e-mail: denise.tilton@gtc-bio.com

No publications provided

Responsible Party:	GTC Biotherapeutics
ClinicalTrials.gov Identifier:	NCT00110513 History of Changes
Other Study ID Numbers:	GTC AT HD 012-04
Study First Received:	May 10, 2005
Results First Received:	March 19, 2012
Last Updated:	August 10, 2012
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board Australia: Human Research Ethics Committee Australia: National Health and Medical Research Council Austria: Ethikkommission Austria: Federal Ministry for Health and Women Canada: Ethics Review Committee Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Institutional Ethical Committee Germany: Ethics Commission Germany: Paul-Ehrlich-Institut Italy: Ethics Committee Italy: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee

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