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

NCT00861692 | Completed Phase 2 Results

• 1 other identifier: ARG-E07
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Heparin-induced Thrombocytopenia Type II

Keywords

Argatroban; heparin induced thrombocytopenia (HIT); direct thrombin inhibitor (DTI)

Outcome Measures

Primary Outcomes (7)

• Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation

  During and 30 days after argatroban treatment

• All-cause Death

  During and 30 days after argatroban treatment

• Death Related to Heparin-induced Thrombocytopenia (HIT)

  During and 30 days after argatroban treatment

• Number of Patients With Thrombosis (New and Extended)

  During and 30 days after argatroban treatment

• Number of Patients With Unplanned Amputation

  During and 30 days after argatroban treatment

• Number of Patients With Major or Minor Bleeding

  Major bleeding is defined as i) overt and associated with a fall in the haemoglobin level 2 g/dl or more, ii) leads to transfusion of 2 units or more, iii) is retroperitoneal, iv) occurs into a major prosthetic joint, or v) in intracranial. Minor bleeding is defined as overt bleeding that does not meet the criteria of major bleeding.

  During and 30 days after argatroban treatment

• Number of Patients With Platelet Count Recovery

  Platelet increase of ≥ 100G/L or 50%.

  Day 3

Study Arms (1)

Argatroban

EXPERIMENTAL

Drug: argatroban

Interventions

argatroban DRUG

Argatroban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Uncontrolled bleeding
• Severe hepatic impairment (Child-Pugh Class C)
• Hypersensitivity to argatroban or to any of the excipients (sorbitol and ethanol)
• Lactating woman

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Unknown Facility

Saint-Etienne, France

Location

Related Publications (1)

• Tardy-Poncet B, Nguyen P, Thiranos JC, Morange PE, Biron-Andreani 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. Crit Care. 2015 Nov 11;19:396. doi: 10.1186/s13054-015-1109-0.

  PMID: 26556106 RESULT

MeSH Terms

Interventions

argatroban

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Professor

  Information at Mitsubishi Pharma Europe

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: April 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: January 6, 2026
• Results First Posted: December 22, 2015

Record last verified: 2025-12

Locations

FR (1)