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Clinical Trials/EUCTR2008-000730-42-FR
EUCTR2008-000730-42-FR
Active, not recruiting
Phase 1

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

Mitsubishi Tanabe Pharma Corporation0 sites20 target enrollmentMarch 12, 2009
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DrugsNovastan 100 mg/ml concentrate for solution for infusion

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Mitsubishi Tanabe Pharma Corporation
Enrollment
20
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 12, 2009
End Date
February 2, 2011
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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