NCT01384409

Brief Summary

To evaluate the efficacy and safety of KW-3357 with concomitant use of heparin using multi-center, non-comparative, open-label method in patients diagnosed as disseminated intravascular coagulation (DIC) by Japanese Association for Acute Medicine-defined DIC criteria.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

June 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

June 27, 2011

Last Update Submit

March 22, 2017

Conditions

Disseminated Intravascular Coagulation (DIC)

Outcome Measures

Primary Outcomes (7)

  • Safety

    Number of patients with adverse events

    up to 6 days (or discontinuation)

  • DIC resolution

    Japanese Association for Acute Medicine-defined DIC criteria score \< 4

    6 days (or discontinuation)

  • DIC score

    Based on the Japanese Association for Acute Medicine-defined DIC criteria

    Screening, 2, 3, 4, 5, 6 days (or discontinuation)

  • Mortality

    28 days

  • Organ symptoms

    Sepsis related organ failure assessment score

    Screening, 4, 6 days (or discontinuation)

  • Severity

    The Acute Physiology and Chronic Health Evaluation II score

    Screening, 4, 6 days (or discontinuation)

  • Plasma antithrombin activity

    Screening, 2, 3, 4, 5, 6 days (or discontinuation)

Study Arms (1)

KW-3357

EXPERIMENTAL
Drug: KW-3357

Interventions

KW-3357DRUG

Intravenous infusion once a day

KW-3357

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
  • Antithrombin activity \<= 70%
  • Written informed consent from patient or guardian

You may not qualify if:

  • Anamnesis or complication of serious drug allergy
  • Serious liver disorder, such as fulminant hepatitis and decompensated cirrhosis
  • Pregnant, nursing, or possibly pregnant woman
  • Possibility for the promotion of bleeding by concomitant use of heparin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Saga, Japan

Location

MeSH Terms

Conditions

Disseminated Intravascular Coagulation

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersThrombophilia

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2011

First Posted

June 29, 2011

Study Start

February 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 24, 2017

Record last verified: 2017-03

Locations

JP(1)