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

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.

Completed

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Key information

Conditions

Disseminated Intravascular Coagulation Blood Coagulation Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Thrombophilia

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ōita, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ART-123

Drug

380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days

Other names: Recomodulin™

Primary outcomes

Composite of Pharmacokinetics

Time frame: pre-dose, 0,2,4,8,24 hours post-dose

Cmax, Area Under Curve, T1/2,CLtot,CLR
Incidence rate of hemorrhage related adverse events

Time frame: from the start of infusion to 8days after the cessation of infusion

Sponsors and collaborators

Lead sponsor

Asahi Kasei Therapeutics Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2014
First posted: Oct 11, 2012
Registry last updated: Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed