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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01704001
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation

Tracking Information
First Submitted Date  ICMJE October 1, 2012
First Posted Date  ICMJE October 11, 2012
Last Update Posted Date February 15, 2017
Study Start Date  ICMJE October 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2012)
  • Composite of Pharmacokinetics [ Time Frame: 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 [ Time Frame: from the start of infusion to 8days after the cessation of infusion ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2012)
  • Composite of Pharmacokinetics [ Time Frame: pre-dose, 0,2,4,8,24 hours post-dose ]
    Cmax, Area Under Curve, T1/2,CLtot,CLR
  • Incidence rate of adverse events related to hemorrhage symptom [ Time Frame: from the start of infusion to 8days after the cessation of infusion ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment
Official Title  ICMJE A Post-Marketing Clinical Pharmacokinetics Study of ART-123 in DIC Subjects With Renal Impairment
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Disseminated Intravascular Coagulation
Intervention  ICMJE Drug: ART-123
380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
Other Name: Recomodulin™
Study Arms  ICMJE
  • Experimental: Renal impairment grade 0
    Intervention: Drug: ART-123
  • Experimental: Renal impairment grade 1
    Intervention: Drug: ART-123
  • Experimental: Renal impairment grade 2
    Intervention: Drug: ART-123
  • Experimental: Renal impairment grade 3
    Intervention: Drug: ART-123
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 9, 2012)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01704001
Other Study ID Numbers  ICMJE ART-123 IV-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Asahi Kasei Pharma Corporation
Study Sponsor  ICMJE Asahi Kasei Pharma Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Asahi Kasei Pharma Corporation
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP