Disseminated Intravascular Coagulation (DIC)Phase 33357-004NCT01384903
An Open-label Study of KW-3357
A Phase 3 study testing KW-3357 and Plasma-derived antithrombin in people with Disseminated Intravascular Coagulation (DIC), run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Disseminated Intravascular Coagulation (DIC)
- What is being tested?
- KW-3357 and Plasma-derived antithrombin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2011to May 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Anamnesis or complication of serious drug allergy
- Serious liver disorder, such as fulminant hepatitis and decompensated cirrhosis
- Pregnant, nursing, or possibly pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Study of KW-3357 Compared to Plasma-derived Antithrombin for Disseminated Intravascular Coagulation (DIC) Associated With Infection
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.
- Being tested
- KW-3357, Plasma-derived antithrombin
- Medical subject headings
- Disseminated Intravascular Coagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KW-3357Drug
Intravenous infusion once a day
Plasma-derived antithrombinDrug
Intravenous infusion once a day
| Study group | Role | What they receive |
|---|---|---|
| KW-3357 | Experimental | Not described Receives: Drug: KW-3357 |
| Plasma-derived antithrombin | Active comparator | Not described Receives: Drug: Plasma-derived antithrombin |
What is being measured
The primary outcome is the main question the study is designed to answer.
DIC resolution
Japanese Association for Acute Medicine-defined DIC criteria score < 4
Measured: 6 days (or discontinuation)
Secondary outcomes (6)
DIC score
Based on the Japanese Association for Acute Medicine-defined DIC criteria score
Measured: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Mortality
Measured: 28 days
Organ symptoms
Sepsis related organ failure assessment score
Measured: Screening, 4, 6 days (or discontinuation)
Severity
The Acute Physiology and Chronic Health Evaluation II score
Measured: Screening, 4, 6 days (or discontinuation)
Plasma antithrombin activity
Measured: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Number of patients with adverse events
Measured: up to 6 days (or discontinuation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disseminated Intravascular Coagulation (DIC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384903
- Sponsor's protocol ID
- 3357-004
- Acronym
- 3357-004
- Status last verified
- Mar 2017
- First submitted
- 27 Jun 2011
- Last updated
- 24 Mar 2017
- Results posted
- No
Publications
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.
PubMed 30473794
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study of KW-3357 Compared to Plasma-derived Antithrombin for Disseminated Intravascular Coagulation (DIC) Associated With Infection
- ClinicalTrials.gov ID
- NCT01384903
- Acronym / sponsor ID
- 3357-004 / 3357-004
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 29 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KW-3357 | Experimental | Drug: KW-3357 |
| Plasma-derived antithrombin | Active comparator | Drug: Plasma-derived antithrombin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Anamnesis or complication of serious drug allergy
- Serious liver disorder, such as fulminant hepatitis and decompensated cirrhosis
- Pregnant, nursing, or possibly pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KW-3357Intravenous infusion once a day | Drug | KW-3357 |
| Plasma-derived antithrombinIntravenous infusion once a day | Drug | Plasma-derived antithrombin |
Primary outcome
DIC resolution
Time frame: 6 days (or discontinuation)
Japanese Association for Acute Medicine-defined DIC criteria score < 4
6 secondary outcomes
DIC score
Time frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Mortality
Time frame: 28 days
Organ symptoms
Time frame: Screening, 4, 6 days (or discontinuation)
Severity
Time frame: Screening, 4, 6 days (or discontinuation)
Plasma antithrombin activity
Time frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Number of patients with adverse events
Time frame: up to 6 days (or discontinuation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Derived from this study: PubMed 30473794Endo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KW-3357 and Plasma-derived antithrombin in people with Disseminated Intravascular Coagulation (DIC), run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DIC resolution (time frame: 6 days (or discontinuation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01384903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.