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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01704001

Enrollment

Registered

2012-10-11

Start date

2012-10-31

Completion date

2014-06-30

Last updated

2017-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disseminated Intravascular Coagulation

Keywords

ART-123, Disseminated Intravascular Coagulation, Pharmacokinetics

Brief 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.

Interventions

DRUGART-123

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Composite of Pharmacokinetics	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	from the start of infusion to 8days after the cessation of infusion	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026