SepsisPhase 2NCT00487656
Safety and Efficacy of ART-123 in Subjects With Sepsis and Disseminated Intravascular Coagulation
A Phase 2 study testing ART-123 in people with Sepsis and Disseminated Intravascular Coagulation, run by Artisan Pharma, Inc. at 62 sites in 4 countries.
Trial summary
The purpose of this study is to see if ART-123 (recombinant human soluble thrombomodulin) decreases the number of people who die as a result of Disseminated Intravascular Coagulation (DIC) complication of sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Disseminated Intravascular Coagulation
- What is being tested?
- ART-123
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- 62 sitesin 4 countries
- Study dates
- Jul 2007to Aug 2010
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Infection or suspected infection resulting in sepsis and DIC
Who cannot join
- Unable to provide informed consent, or lack of consent from an acceptable surrogate
- Subjects < 18 years of age
- Known conditions that could confound the diagnosis of DIC due to sepsis
- Known conditions that increase the risk of bleeding
- Known medical condition associated with a hypercoagulable state
- Known or suspected severe liver disease
- History of solid organ (excluding uncomplicated kidney), bone marrow or stem cell transplantation
- Renal failure
Trial locations and contacts
62 sites in 4 countries.
62 sites in 4 countries
United States49 sites
Study site
Akron, Ohio
Study site
Ann Arbor, Michigan
Study site
Atlanta, Georgia
Study site
Augusta, Georgia
Study site
Bakersfield, California
Study site
Bay Pines, Florida
Study site
Birmingham, Alabama
Study site
Camden, New Jersey
Study site
Celebration, Florida
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Colton, California
Study site
Columbia, South Carolina
Study site
Columbus, Ohio
Study site
Danville, Pennsylvania
Study site
Durham, North Carolina
Study site
Englewood, New Jersey
Study site
Fayetteville, North Carolina
Study site
Flushing, New York
Study site
Hartford, Connecticut
Study site
Hazard, Kentucky
Study site
Houston, Texas
Study site
Jacksonville, Florida
Study site
Kalamazoo, Michigan
Study site
Kansas City, Kansas
Study site
Kettering, Ohio
Study site
Knoxville, Tennessee
Study site
Lackland Air Force Base, Texas
Study site
Loma Linda, California
Study site
Long Beach, California
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
Miami, Florida
Study site
Newark, New Jersey
Study site
Orlando, Florida
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Pontiac, Michigan
Study site
Rancho Mirage, California
Study site
San Diego, California
Study site
San Francisco, California
Study site
Shreveport, Louisiana
Study site
Springfield, Illinois
Study site
Springfield, Massachusetts
Study site
Stanford, California
Study site
Toledo, Ohio
Study site
Topeka, Kansas
Study site
Tuscon, Arizona
Study site
Winston-Salem, North Carolina
Canada8 sites
Study site
Edmonton, Alberta
Study site
Greenfield Park, Quebec
Study site
Kingston, Ontario
Study site
London, Ontario
Study site
Oshawa, Ontario
Study site
Ottawa, Ontario
Study site
Victoria, British Columbia
Study site
Windsor, Ontario
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase-2B Study to Assess the Safety and Efficacy Effects of ART-123 on Subjects With Sepsis and Disseminated Intravascular Coagulation
The purpose of this study is to see if ART-123 (recombinant human soluble thrombomodulin) decreases the number of people who die as a result of Disseminated Intravascular Coagulation (DIC) complication of sepsis.
- Conditions
- Sepsis, Disseminated Intravascular Coagulation
- Being tested
- ART-123, placebo
- Medical subject headings
- Sepsis, Disseminated Intravascular Coagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ART-123Drug
6mg/ml ampule solution for injection @ .01mg/kg
placeboDrug
6 mg/ml ampule solution for injection at .01mg/kg
| Study group | Role | What they receive |
|---|---|---|
| ART-123 | Experimental | 6 mg/ml ampule solution for injection Receives: Drug: ART-123 |
| Placebo | Placebo comparator | 6 mg/mlampule of solution for injection Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-Day All-cause mortality
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionMay 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artisan Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487656
- Sponsor's protocol ID
- 2-001
- Status last verified
- May 2011
- First submitted
- 15 Jun 2007
- Last updated
- 18 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase-2B Study to Assess the Safety and Efficacy Effects of ART-123 on Subjects With Sepsis and Disseminated Intravascular Coagulation
- ClinicalTrials.gov ID
- NCT00487656
- Acronym / sponsor ID
- 2-001
- Conditions
- Sepsis, Disseminated Intravascular Coagulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Artisan Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 18 Jun 2007 (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 see if ART-123 (recombinant human soluble thrombomodulin) decreases the number of people who die as a result of Disseminated Intravascular Coagulation (DIC) complication of sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ART-123 | Experimental | Drug: ART-1236 mg/ml ampule solution for injection |
| Placebo | Placebo comparator | Drug: placebo6 mg/mlampule of solution for injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Infection or suspected infection resulting in sepsis and DIC
Key exclusion criteria (8 listed)
- Unable to provide informed consent, or lack of consent from an acceptable surrogate
- Subjects < 18 years of age
- Known conditions that could confound the diagnosis of DIC due to sepsis
- Known conditions that increase the risk of bleeding
- Known medical condition associated with a hypercoagulable state
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 |
|---|---|---|
| ART-1236mg/ml ampule solution for injection @ .01mg/kg | Drug | ART-123 |
| placebo6 mg/ml ampule solution for injection at .01mg/kg | Drug | Placebo |
Primary outcome
28-Day All-cause mortality
Time frame: 28 day
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 18 May 2011.
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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.
62 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ART-123 in people with Sepsis and Disseminated Intravascular Coagulation, run by Artisan Pharma, Inc. at 62 sites in 4 countries.
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 1 inclusion and 8 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 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Canada, Malaysia, Thailand. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
28-Day All-cause mortality (time frame: 28 day). 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 18 May 2011.