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

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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

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.


Condition or disease Intervention/treatment Phase
Disseminated Intravascular Coagulation Drug: ART-123 Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Post-Marketing Clinical Pharmacokinetics Study of ART-123 in DIC Subjects With Renal Impairment
Study Start Date : October 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : June 2014

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 Name: 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 Name: 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 Name: 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 Name: Recomodulin™




Primary Outcome Measures :
  1. Composite of Pharmacokinetics [ Time Frame: pre-dose, 0,2,4,8,24 hours post-dose ]
    Cmax, Area Under Curve, T1/2,CLtot,CLR

  2. Incidence rate of hemorrhage related adverse events [ Time Frame: from the start of infusion to 8days after the cessation of infusion ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704001


Locations
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Japan
Oita, Japan
Sponsors and Collaborators
Asahi Kasei Pharma Corporation

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Responsible Party: Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier: NCT01704001     History of Changes
Other Study ID Numbers: ART-123 IV-2
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: October 2012
Keywords provided by Asahi Kasei Pharma Corporation:
ART-123
Disseminated Intravascular Coagulation
Pharmacokinetics
Additional relevant MeSH terms:
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Disseminated Intravascular Coagulation
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Thrombophilia