NCT01384903

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of KW-3357 compared to plasma-derived antithrombin using multi-center, open-label, parallel-group, comparative method in patients with Disseminated Intravascular Coagulation (DIC) associated with infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
221

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2011

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

Study Start

First participant enrolled

June 1, 2011

Completed
26 days until next milestone

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
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

June 27, 2011

Last Update Submit

March 22, 2017

Conditions

Disseminated Intravascular Coagulation (DIC)

Outcome Measures

Primary Outcomes (1)

  • DIC resolution

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

    6 days (or discontinuation)

Secondary Outcomes (6)

  • DIC score

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

  • Mortality

    28 days

  • Organ symptoms

    Screening, 4, 6 days (or discontinuation)

  • Severity

    Screening, 4, 6 days (or discontinuation)

  • Plasma antithrombin activity

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

  • +1 more secondary outcomes

Study Arms (2)

KW-3357

EXPERIMENTAL
Drug: KW-3357

Plasma-derived antithrombin

ACTIVE COMPARATOR
Drug: Plasma-derived antithrombin

Interventions

KW-3357DRUG

Intravenous infusion once a day

KW-3357
Plasma-derived antithrombinDRUG

Intravenous infusion once a day

Plasma-derived antithrombin

Eligibility Criteria

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

You may qualify if:

  • Meet the ACCP/SCCM-defined sepsis criteria
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Saga, Japan

Location

Related Publications (1)

  • Endo S, Shimazaki R; Antithrombin Gamma Study Group. An open-label, randomized, phase 3 study of the efficacy and safety of antithrombin gamma in patients with sepsis-induced disseminated intravascular coagulation syndrome. J Intensive Care. 2018 Nov 16;6:75. doi: 10.1186/s40560-018-0339-z. eCollection 2018.

    PMID: 30473794DERIVED

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2011

First Posted

June 29, 2011

Study Start

June 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 24, 2017

Record last verified: 2017-03

Locations

JP(1)