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NCT01704001 Clinical Trial

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

Disseminated Intravascular Coagulation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01704001
Other study ID # ART-123 IV-2
Secondary ID
Status Completed
Phase Phase 4
First received October 1, 2012
Last updated February 13, 2017
Start date October 2012
Est. completion date June 2014

Study information
Verified date October 2012
Source Asahi Kasei Pharma Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date June 2014
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ART-123
380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Asahi Kasei Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite of Pharmacokinetics Cmax, Area Under Curve, T1/2,CLtot,CLR pre-dose, 0,2,4,8,24 hours post-dose
Primary Incidence rate of hemorrhage related adverse events from the start of infusion to 8days after the cessation of infusion
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