Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II

Heparin-induced Thrombocytopenia Type II Clinical Trial

Official title:

An Open-label, Multi-centre, Clinical Study to Collect Information on the Clinical Use of Argatroban in Patients With Heparin Induced Thrombocytopenia (HIT) Type II Who Require Parenteral Antithrombotic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861692
• Other study ID #: ARG-E07
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2009
• Last updated: November 17, 2015
• Start date: April 2009
• Est. completion date: February 2011

Study information

• Verified date: November 2015
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to collect data on the clinical management of Argatroban in patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral antithrombotic therapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects aged >= 18 years

• Females of child bearing potential must have a negative urine pregnancy test prior to entry into the study

• Patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral anticoagulation

• Signed written informed consent by the subject, or if the subject is unable to do so, consent will be sought from their family member, or a trusted person nominated by the subject or the legal representative

Exclusion Criteria:

• Uncontrolled bleeding

• Severe hepatic impairment (Child-Pugh Class C)

• Hypersensitivity to argatroban or to any of the excipients (sorbitol and ethanol)

• Pregnancy (exclusion by routine urine test)

• Lactating woman

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heparin-induced Thrombocytopenia Type II
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• argatroban

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

France, 

References & Publications (1)

Tardy-Poncet B, Nguyen P, Thiranos JC, Morange PE, Biron-Andréani C, Gruel Y, Morel J, Wynckel A, Grunebaum L, Villacorta-Torres J, Grosjean S, de Maistre E. Argatroban in the management of heparin-induced thrombocytopenia: a multicenter clinical trial. C — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation		During and 30 days after argatroban treatment	No
Primary	All-cause Death		During and 30 days after argatroban treatment	No
Primary	Death Related to HIT		During and 30 days after argatroban treatment	No
Primary	Thrombosis (New and Extended)		During and 30 days after argatroban treatment	No
Primary	Unplanned Amputation		During and 30 days after argatroban treatment	No
Primary	Major or Minor Bleeding		During and 30 days after argatroban treatment	Yes
Primary	Platelet Count Recovery	Platelet increase of = 100 G/L or 50 %. Data are missing in 4 patients.	End of treatment	No