Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment
- Registration Number
- NCT01704001
- Lead Sponsor
- Asahi Kasei Pharma Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Renal impairment grade 2 ART-123 - Renal impairment grade 0 ART-123 - Renal impairment grade 1 ART-123 - Renal impairment grade 3 ART-123 -
- Primary Outcome Measures
Name Time Method Composite of Pharmacokinetics pre-dose, 0,2,4,8,24 hours post-dose Cmax, Area Under Curve, T1/2,CLtot,CLR
Incidence rate of hemorrhage related adverse events from the start of infusion to 8days after the cessation of infusion
- Secondary Outcome Measures
Name Time Method