Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00861692
First received: March 12, 2009
Last updated: July 22, 2011
Last verified: July 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Heparin-induced Thrombocytopenia Type II
 Drug: argatroban
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Composite of all-cause death, thrombosis (new and extended) and unplanned amputation
  • All-cause death
  • Death related to HIT
  • Thrombosis (new and extended)
  • Unplanned amputation
  • Major / minor bleeding
  • PK/PD parameters

Estimated Enrollment: 20
Study Start Date: April 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861692

Locations
France
Saint Etienne, France
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Principal Investigator: Professor Information at Mitsubishi Pharma Europe
  More Information

No publications provided

Responsible Party: Study Project Manager, Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00861692     History of Changes
Other Study ID Numbers: ARG-E07
Study First Received: March 12, 2009
Last Updated: July 22, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Argatroban
heparin induced thrombocytopenia (HIT)
direct thrombin inhibitor (DTI)

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Antithrombins
Argatroban
Heparin
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013