Myocardial IschemiaPhase 2NCT00082121
Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
A Phase 2 study testing TP10 in people with Myocardial Ischemia and Coronary Arteriosclerosis, run by Avant Immunotherapeutics at 18 sites in United States.
Trial summary
The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side effects of complement inflammation as chest pain or heart attacks and be taken safely in women who undergo cardiopulmonary bypass surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Myocardial Ischemia, Coronary Arteriosclerosis, Aortic Valve Insufficiency
- What is being tested?
- TP10
- How many people
- 300 participants
- Where
- 18 sitesUnited States
- Study dates
- Apr 2004to Dec 2005
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- To undergo high-risk cardiac surgery with cardiopulmonary bypass pump (CPB)
- CABG alone or with valve surgery
Who cannot join
- Acute myocardial infarction (heart attack) within a 3 days of entering the study
- Conditions that may interfere with interpretation of electrocardiogram data
- History of immune deficiency syndrome
- Planned supplemental cardiac surgery or other surgery
- Pregnancy or lactation
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Study site
Atlanta, Georgia, 30342
Study site
Boston, Massachusetts, 02118
Study site
Chicago, Illinois, 60612
Study site
Cincinnati, Ohio, 45219
Study site
Danville, Virginia, 24541
Study site
Detroit, Michigan, 48202
Study site
Gainesville, Florida, 32610
Study site
Houston, Texas, 77030
Study site
Lansing, Michigan, 48910
Study site
Madison, Wisconsin, 53792
Study site
Memphis, Tennessee, 38120
Study site
Milwaukee, Wisconsin, 53215
Study site
Orlando, Florida, 32803
Study site
San Francisco, California, 94115
Study site
Sarasota, Florida, 34239
Study site
Springfield, Massachusetts, 01199
Study site
Towson, Maryland, 21204
Study site
Washington D.C., District of Columbia, 20010
About this study
The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side effects of complement inflammation as chest pain or heart attacks and be taken safely in women who undergo cardiopulmonary bypass surgery.
Read the detailed description
During cardiac surgery, a substance called "complement" is released by the body. This complement causes inflammation, which can lead to side effects such as chest pain, heart attacks, or heart failure. The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side events and be taken safely in women.
- Conditions
- Myocardial Ischemia, Coronary Arteriosclerosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Being tested
- TP10
- Keywords
- cardiac bypass, CABG, complement activation
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease, Aortic Valve Insufficiency, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP10Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in death & myocardial infarction (MI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2004 (estimated)
- Study startApr 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Avant Immunotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082121
- Sponsor's protocol ID
- TP10-ACS-002
- Status last verified
- Jul 2007
- First submitted
- 29 Apr 2004
- Last updated
- 20 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
- ClinicalTrials.gov ID
- NCT00082121
- Acronym / sponsor ID
- TP10-ACS-002
- Conditions
- Myocardial Ischemia, Coronary Arteriosclerosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Keywords
- cardiac bypass, CABG, complement activation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Avant ImmunotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Dec 2005
- First posted
- 4 May 2004 (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 determine if the study drug (TP10), which blocks complement release, can reduce such side effects of complement inflammation as chest pain or heart attacks and be taken safely in women who undergo cardiopulmonary bypass surgery.
Detailed description
During cardiac surgery, a substance called "complement" is released by the body. This complement causes inflammation, which can lead to side effects such as chest pain, heart attacks, or heart failure. The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side events and be taken safely in women.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- To undergo high-risk cardiac surgery with cardiopulmonary bypass pump (CPB)
- CABG alone or with valve surgery
Key exclusion criteria (5 listed)
- Acute myocardial infarction (heart attack) within a 3 days of entering the study
- Conditions that may interfere with interpretation of electrocardiogram data
- History of immune deficiency syndrome
- Planned supplemental cardiac surgery or other surgery
- Pregnancy or lactation
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 |
|---|---|---|
| TP10 | Drug | – |
Primary outcome
Reduction in death & myocardial infarction (MI)
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 20 Jul 2007.
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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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TP10 in people with Myocardial Ischemia and Coronary Arteriosclerosis, run by Avant Immunotherapeutics at 18 sites in United States.
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 5 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 20 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. 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 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?
Reduction in death & myocardial infarction (MI). 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 20 Jul 2007; AzTrials last refreshed its copy on 8 Nov 2026.