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

July 1, 2016 updated by: Mitsubishi Tanabe Pharma Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint Etienne, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Argatroban
Drug: argatroban

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation
Time Frame: During and 30 days after argatroban treatment
During and 30 days after argatroban treatment
All-cause Death
Time Frame: During and 30 days after argatroban treatment
During and 30 days after argatroban treatment
Death Related to Heparin-induced Thrombocytopenia (HIT)
Time Frame: During and 30 days after argatroban treatment
During and 30 days after argatroban treatment
Number of Patients With Thrombosis (New and Extended)
Time Frame: During and 30 days after argatroban treatment
During and 30 days after argatroban treatment
Number of Patients With Unplanned Amputation
Time Frame: During and 30 days after argatroban treatment
During and 30 days after argatroban treatment
Number of Patients With Major or Minor Bleeding
Time Frame: During and 30 days after argatroban treatment

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
Time Frame: Day 3
Platelet increase of ≥ 100G/L or 50%.
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

March 12, 2009

First Submitted That Met QC Criteria

March 12, 2009

First Posted (Estimate)

March 13, 2009

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 1, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARG-E07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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