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

Asahi Kasei Pharma Corporation40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Disseminated Intravascular Coagulation

Interventions

ART-123DRUG

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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)

Unnamed facility

Ōita, Japan

Outcomes

Primary Outcomes

Composite of Pharmacokinetics

Cmax, Area Under Curve, T1/2,CLtot,CLR

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

Incidence rate of hemorrhage related adverse events

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

Data from ClinicalTrials.gov

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