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

NCT01704001 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-02-15

No results posted yet for this study

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.

Conditions

  • Disseminated Intravascular Coagulation

Interventions

DRUG

ART-123

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

Sponsors & Collaborators

  • Asahi Kasei Pharma Corporation

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-10-31
Completion
2014-06-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01704001 on ClinicalTrials.gov