Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment
NCT ID: NCT01704001
Last Updated: 2017-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2012-10-31
2014-06-30
Brief Summary
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To investigate the safety of ART-123 in patients with Disseminated Intravascular Coagulation.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Renal impairment grade 0
ART-123
380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
Renal impairment grade 1
ART-123
380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
Renal impairment grade 2
ART-123
380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
Renal impairment grade 3
ART-123
380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
Interventions
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ART-123
380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent from patient or guardian
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Asahi Kasei Pharma Corporation
INDUSTRY
Responsible Party
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Locations
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Ōita, , Japan
Countries
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Other Identifiers
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ART-123 IV-2
Identifier Type: -
Identifier Source: org_study_id
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