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

Primary Purpose

Heparin-induced Thrombocytopenia Type II

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

argatroban

About this trial

This is an interventional treatment trial for Heparin-induced Thrombocytopenia Type II focused on measuring Argatroban, heparin induced thrombocytopenia (HIT), direct thrombin inhibitor (DTI)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Argatroban

Arm Description

Outcomes

Primary Outcome Measures

Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation

All-cause Death

Death Related to Heparin-induced Thrombocytopenia (HIT)

Number of Patients With Thrombosis (New and Extended)

Number of Patients With Unplanned Amputation

Number of Patients With Major or Minor Bleeding

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.

Number of Patients With Platelet Count Recovery

Platelet increase of ≥ 100G/L or 50%.

Secondary Outcome Measures

Full Information

NCT ID

NCT00861692

First Posted

March 12, 2009

Last Updated

July 1, 2016

Sponsor

Mitsubishi Tanabe Pharma Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00861692

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heparin-induced Thrombocytopenia Type II

Keywords

Argatroban, heparin induced thrombocytopenia (HIT), direct thrombin inhibitor (DTI)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Argatroban

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

argatroban

Primary Outcome Measure Information:

Title

Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation

Time Frame