Disseminated Intravascular Coagulation (DIC)Phase 33357-005NCT01384396
A Clinical Study of KW-3357 in Patients With DIC
A Phase 3 study testing KW-3357 in people with Disseminated Intravascular Coagulation (DIC), run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial 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 the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2011to Apr 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
- Diagnosed or suspected as DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
- 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
- Possibility for the promotion of bleeding by concomitant use of heparin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study of KW-3357 in Patients Diagnosed as Disseminated Intravascular Coagulation (DIC) by the Diagnostic Criteria for DIC Established by the Japanese Ministry of Health and Welfare
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 the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare.
- Being tested
- KW-3357
- 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
| Study group | Role | What they receive |
|---|---|---|
| KW-3357 | Experimental | Not described Receives: Drug: KW-3357 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Number of patients with adverse events
Measured: up to 6 days (or discontinuation)
DIC resolution
Resolution from DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
Measured: 6 days (or discontinuation)
Secondary outcomes (3)
DIC score
Based on the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
Measured: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Mortality
Measured: 28 days
Plasma antithrombin activity
Measured: Screening, 2, 3, 4, 5, 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 startDec 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disseminated Intravascular Coagulation (DIC)Studies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT01384396
- Sponsor's protocol ID
- 3357-005
- Acronym
- 3357-005
- Status last verified
- Mar 2017
- First submitted
- 27 Jun 2011
- Last updated
- 24 Mar 2017
- Results posted
- No
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
- A Clinical Study of KW-3357 in Patients Diagnosed as Disseminated Intravascular Coagulation (DIC) by the Diagnostic Criteria for DIC Established by the Japanese Ministry of Health and Welfare
- ClinicalTrials.gov ID
- NCT01384396
- Acronym / sponsor ID
- 3357-005 / 3357-005
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 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.
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 the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KW-3357 | Experimental | Drug: KW-3357 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed or suspected as DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
- Antithrombin activity <= 70%
- Written informed consent from patient or guardian
Key exclusion criteria (4 listed)
- 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
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 |
Primary outcome
Safety
Time frame: up to 6 days (or discontinuation)
Number of patients with adverse events
DIC resolution
Time frame: 6 days (or discontinuation)
Resolution from DIC by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare
3 secondary outcomes
DIC score
Time frame: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Mortality
Time frame: 28 days
Plasma antithrombin activity
Time frame: Screening, 2, 3, 4, 5, 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.
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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 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 3 inclusion and 4 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?
Safety (time frame: up to 6 days (or discontinuation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.