Heparin-induced Thrombocytopenia Type IIPhase 2NCT00861692
Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II
A Phase 2 study testing argatroban in people with Heparin-induced Thrombocytopenia Type II, run by Tanabe Pharma Corporation at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heparin-induced Thrombocytopenia Type II
- What is being tested?
- argatroban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Feb 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Heparin-induced Thrombocytopenia Type II
- Being tested
- argatroban
- Keywords
- Argatroban, heparin induced thrombocytopenia (HIT), direct thrombin inhibitor (DTI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
argatrobanDrug
| Study group | Role | What they receive |
|---|---|---|
| Argatroban | Experimental | Not described Receives: Drug: argatroban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation
Measured: During and 30 days after argatroban treatment
All-cause Death
Measured: During and 30 days after argatroban treatment
Death Related to Heparin-induced Thrombocytopenia (HIT)
Measured: During and 30 days after argatroban treatment
Number of Patients With Thrombosis (New and Extended)
Measured: During and 30 days after argatroban treatment
Number of Patients With Unplanned Amputation
Measured: During and 30 days after argatroban treatment
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.
Measured: During and 30 days after argatroban treatment
Number of Patients With Platelet Count Recovery
Platelet increase of ≥ 100G/L or 50%.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heparin-induced Thrombocytopenia Type IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Professor, Principal investigator, Information at Mitsubishi Pharma Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861692
- Sponsor's protocol ID
- ARG-E07
- Status last verified
- Dec 2025
- First submitted
- 12 Mar 2009
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tardy-Poncet B, Nguyen P, Thiranos JC, Morange PE, Biron-Andreani C, Gruel Y, Morel J, Wynckel A, Grunebaum L, Villacorta-Torres J, Grosjean S, de Maistre E. Argatroban in the management of heparin-induced thrombocytopenia: a multicenter clinical trial. Crit Care. 2015 Nov 11;19:396. doi: 10.1186/s13054-015-1109-0.
PubMed 26556106
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00861692
- Acronym / sponsor ID
- ARG-E07
- Conditions
- Heparin-induced Thrombocytopenia Type II
- Keywords
- Argatroban, heparin induced thrombocytopenia (HIT), direct thrombin inhibitor (DTI)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Posted 22 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Argatroban | Experimental | Drug: argatroban |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| argatroban | Drug | Argatroban |
Primary outcome
Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation
Time frame: During and 30 days after argatroban treatment
All-cause Death
Time frame: During and 30 days after argatroban treatment
Death Related to Heparin-induced Thrombocytopenia (HIT)
Time frame: During and 30 days after argatroban treatment
Number of Patients With Thrombosis (New and Extended)
Time frame: During and 30 days after argatroban treatment
Number of Patients With Unplanned Amputation
Time frame: 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.
Number of Patients With Platelet Count Recovery
Time frame: Day 3
Platelet increase of ≥ 100G/L or 50%.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26556106Tardy-Poncet B, Nguyen P, Thiranos JC, Morange PE, Biron-Andreani C, Gruel Y, Morel J, Wynckel A, Grunebaum L, Villacorta-Torres J, Grosjean S, de Maistre E. Argatroban in the management of heparin-induced thrombocytopenia: a multicenter clinical trial. Crit Care. 2015 Nov 11;19:396. doi: 10.1186/s13054-015-1109-0.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor principal investigator
Information at Mitsubishi Pharma Europe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing argatroban in people with Heparin-induced Thrombocytopenia Type II, run by Tanabe Pharma Corporation at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation (time frame: During and 30 days after argatroban treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00861692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.