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. - ARG-E07

Phase 1

Active, not recruiting

• Conditions: Heparin induced thrombocytopenia (HIT) Type II; MedDRA version: 9.1Level: LLTClassification code 10048672Term: Heparin-induced thrombocytopenia type II

• Registration Number: EUCTR2008-000730-42-FR
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-12
• Study Completion: 2011-02-02
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Subjects aged = 18 years

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

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

4. 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Uncontrolled bleeding
2. Severe hepatic impairment (Child-Pugh Class C)
3. Hypersensitivity to argatroban or to any of the excipients (sorbitol and ethanol)
4. Pregnancy (exclusion by routine urine test)
5. Lactating woman

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified