Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198588
Status:
COMPLETED
Last Update Posted:
2008-11-13
First Post:
2005-09-12
Brief Title:
Efficacy and Safety Study of Argatroban to Treat Heparin-Induced Thrombocytopenia
Sponsor:
Ministry of Health Labour and Welfare Japan
Organization:
Ministry of Health Labour and Welfare Japan
Study Overview
Official Title:
Open-Label Trial to Evaluate the Efficacy and Safety of the Use of Argatroban in Patients With Heparin-Induced Thrombocytopenia
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate efficacy and safety of argatroban in the patients with heparin-induced thrombocytopenia HIT HIT and thrombosis syndrome HITTS This multi-center trial covers mainly the patients with cardiovascular diseases Subjects are included in the trial when they are clinically diagnosed of HITHITTS Initial dose of argatroban is 07μgkgmin which is about one-third of the approved dose in the US The reason of the lower initial dose is that the approved dose of argatroban in Japan for the treatment of ischemic stroke is about 07μgkgmin and safety of higher doses of the drug are not confirmed A sub-study of pharmacokinetics is simultaneously conducted to reveal the relationship among the dose aPTT and blood drug concentration
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None