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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00861692
• Date of registration: 12/03/2009
• Prospective Registration: Yes
• Primary sponsor: Mitsubishi Tanabe Pharma Corporation
• Public title: Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II
• Scientific 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
• Date of first enrolment: April 2009
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00861692
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Professor
• Affiliation: Information at Mitsubishi Pharma Europe

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heparin-induced Thrombocytopenia Type II

Intervention(s)

Drug: argatroban

Primary Outcome(s)

All-cause Death [Time Frame: During and 30 days after argatroban treatment]

Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation [Time Frame: During and 30 days after argatroban treatment]

Number of Patients With Unplanned Amputation [Time Frame: During and 30 days after argatroban treatment]

Death Related to Heparin-induced Thrombocytopenia (HIT) [Time Frame: During and 30 days after argatroban treatment]

Number of Patients With Major or Minor Bleeding [Time Frame: During and 30 days after argatroban treatment]

Number of Patients With Platelet Count Recovery [Time Frame: Day 3]

Number of Patients With Thrombosis (New and Extended) [Time Frame: During and 30 days after argatroban treatment]

Secondary ID(s)

ARG-E07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/12/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00861692