NCT01704001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 15, 2017

Status Verified

October 1, 2012

Enrollment Period

1 year

First QC Date

October 1, 2012

Last Update Submit

February 13, 2017

Conditions

Disseminated Intravascular Coagulation

Keywords

ART-123Disseminated Intravascular CoagulationPharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Composite of Pharmacokinetics

    Cmax, Area Under Curve, T1/2,CLtot,CLR

    pre-dose, 0,2,4,8,24 hours post-dose

  • Incidence rate of hemorrhage related adverse events

    from the start of infusion to 8days after the cessation of infusion

Study Arms (4)

Renal impairment grade 0

EXPERIMENTAL
Drug: ART-123

Renal impairment grade 1

EXPERIMENTAL
Drug: ART-123

Renal impairment grade 2

EXPERIMENTAL
Drug: ART-123

Renal impairment grade 3

EXPERIMENTAL
Drug: ART-123

Interventions

ART-123DRUG

380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days

Also known as: Recomodulin™
Renal impairment grade 0Renal impairment grade 1Renal impairment grade 2Renal impairment grade 3

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Japanese Association for Acute Medicine-defined DIC criteria score \>= 4
  • Written informed consent from patient or guardian

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Ōita, Japan

Location

MeSH Terms

Conditions

Disseminated Intravascular Coagulation

Interventions

ART123

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersThrombophilia

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2012

First Posted

October 11, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

June 1, 2014

Last Updated

February 15, 2017

Record last verified: 2012-10

Locations

JP(1)