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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: Asahi Kasei Pharma Corporation

Current Primary Outcome:

• 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:

• 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 ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Asahi Kasei Pharma Corporation

Dates:
Date Received: October 1, 2012
Date Started: October 2012
Date Completion:
Last Updated: February 13, 2017
Last Verified: October 2012