Back to resultsClinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment
Primary Purpose
Disseminated Intravascular Coagulation
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
ART-123
Sponsored by
About this trial
This is an interventional treatment trial for Disseminated Intravascular Coagulation focused on measuring ART-123, Disseminated Intravascular Coagulation, Pharmacokinetics
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Renal impairment grade 0
Renal impairment grade 1
Renal impairment grade 2
Renal impairment grade 3
Arm Description
Outcomes
Primary Outcome Measures
Composite of Pharmacokinetics
Cmax, Area Under Curve, T1/2,CLtot,CLR
Incidence rate of hemorrhage related adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT01704001
First Posted
October 1, 2012
Last Updated
February 13, 2017
Sponsor
Asahi Kasei Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01704001
Brief Title
Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment
Official Title
A Post-Marketing Clinical Pharmacokinetics Study of ART-123 in DIC Subjects With Renal Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asahi Kasei Pharma Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disseminated Intravascular Coagulation
Keywords
ART-123, Disseminated Intravascular Coagulation, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Renal impairment grade 0
Arm Type
Experimental
Arm Title
Renal impairment grade 1
Arm Type
Experimental
Arm Title
Renal impairment grade 2
Arm Type
Experimental
Arm Title
Renal impairment grade 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ART-123
Other Intervention Name(s)
Recomodulin™
Intervention Description
380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
Primary Outcome Measure Information:
Title
Composite of Pharmacokinetics
Description
Cmax, Area Under Curve, T1/2,CLtot,CLR
Time Frame
pre-dose, 0,2,4,8,24 hours post-dose
Title
Incidence rate of hemorrhage related adverse events
Time Frame
from the start of infusion to 8days after the cessation of infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Oita
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment
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