Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment

A Post-Marketing Clinical Pharmacokinetics Study of ART-123 in DIC Subjects With Renal Impairment

NCT01704001•Asahi Kasei Pharma Corporation

Summary

To investigate the impact of impaired renal function on the pharmacokinetics of ART-123 in patients with Disseminated Intravascular Coagulation. To investigate the safety of ART-123 in patients with Disseminated Intravascular Coagulation.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Japanese Association for Acute Medicine-defined DIC criteria score \>= 4
•Written informed consent from patient or guardian

Exclusion Criteria

•Patients showing intracranial, pulmonary, gastrointestinal hemorrhage
•Patients with a history of cerebrovascular disorders within the past 52 week
•Patients with a history of hypersensitivity to the ingredients of ART-123 preparations
•Pregnant women, nursing mothers or possibly pregnant women

Locations (1)

Ōita, Japan

Key Dates

Start Date

October 1, 2012

Primary Completion Date

October 1, 2013

Completion Date

June 1, 2014

Last Updated

February 15, 2017

Enrollment

ESTIMATED participants

Conditions

Disseminated Intravascular Coagulation

Interventions

ART-123

DRUG

Role of Fibrinolytic Activity in Neoplastic Pathologies Complicated by Coagulopathy

NCT07234630

Hematologic NeoplasmsSolid Tumor Metastatic Cancer Advanced Cancer+1 more

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TERMINATEDPHASE2

Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis

NCT00506519

Disseminated Intravascular Coagulation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment

Inclusion Criteria

Exclusion Criteria

Role of Fibrinolytic Activity in Neoplastic Pathologies Complicated by Coagulopathy

Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis

Safety and Efficacy of ART-123 in Subjects With Sepsis and Disseminated Intravascular Coagulation