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

February 13, 2017 updated by: Asahi Kasei Pharma Corporation

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal impairment grade 0
Drug: ART-123
380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
Other Names:
  • Recomodulin™
Experimental: Renal impairment grade 1
Drug: ART-123
380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
Other Names:
  • Recomodulin™
Experimental: Renal impairment grade 2
Drug: ART-123
380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
Other Names:
  • Recomodulin™
Experimental: Renal impairment grade 3
Drug: ART-123
380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
Other Names:
  • Recomodulin™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of Pharmacokinetics
Time Frame: pre-dose, 0,2,4,8,24 hours post-dose
Cmax, Area Under Curve, T1/2,CLtot,CLR
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
from the start of infusion to 8days after the cessation of infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asahi Kasei Pharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 1, 2012

First Submitted That Met QC Criteria

October 9, 2012

First Posted (Estimate)

October 11, 2012

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ART-123 IV-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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