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

Asahi Kasei Medical

Status and phase: Completed; Phase 4

Conditions: Disseminated Intravascular Coagulation

Treatments: Drug: ART-123

Study type: Interventional

Funder types: Industry

Identifiers

NCT01704001

ART-123 IV-2

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Renal impairment grade 0

Experimental group

Treatment:

Drug: ART-123

Renal impairment grade 1

Experimental group

Treatment:

Drug: ART-123

Renal impairment grade 2

Experimental group

Treatment:

Drug: ART-123

Renal impairment grade 3

Experimental group

Treatment:

Drug: ART-123