Healthy SubjectsPhase 2NCT00368238
Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects
A Phase 2 study testing Recombinant human erythropoietin alfa (drug), Aspirin (drug) and Clopidogrel (drug) in people with Healthy Subjects, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to see if a naturally-occurring hormone called erythropoietin changes the action of platelets in the blood. Erythropoietin is made by the kidneys to stimulate red blood cell production to prevent anemia. Platelets are small cells in the blood that help clot blood in case of injury. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Recombinant human erythropoietin alfa (drug), Aspirin (drug) and Clopidogrel (drug)
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jul 2006
- 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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 21-40 years
- Able and willing to provide written informed consent
- Bleeding time <10 minutes
Who cannot join
- Any chronic medical disease
- Chronic or frequent over-the-counter or prescription medication use
- Hemoglobin >15 gm/dl for both genders or <13 gm/dl (men) or <12 gm/dl (women)
- Platelet count >400,000/µl or <150,000/µl
- Blood pressure > 140/90 mmHg
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06510
About this study
The purpose of this study is to see if a naturally-occurring hormone called erythropoietin changes the action of platelets in the blood. Erythropoietin is made by the kidneys to stimulate red blood cell production to prevent anemia. Platelets are small cells in the blood that help clot blood in case of injury. Platelets also sometimes form blood clots in blood vessels that may cause heart attacks. This study is trying to determine whether erythropoietin increases the clotting action of platelets. Information on erythropoietin in healthy subjects may eventually help in the treatment of patients with heart attacks.
Read the detailed description
Anti-apoptotic effects of erythropoietin in experimental myocardial infarction and ischemia-reperfusion injury suggest potential for therapeutic benefit in patients with acute MI. Before the therapeutic potential of rHuEpo in acute MI can be tested in large clinical trials, more information on the effects of short-term rHuEpo on platelet function are needed. Accordingly, the current proposal aims to determine the effects of 3 doses of rHuEpo (100U/kg, 200U/kg and 400U/kg daily for 3 days) on platelet function and other safety measures in healthy subjects.
Specific Aim: To determine the effects of three ascending doses of rHuEpo vs. placebo on in vivo and in vitro platelet function in healthy subjects treated with aspirin and clopidogrel.
Hypotheses to be tested: 1) 1) Short-term administration of rHuEpo does not alter bleeding time responses to aspirin and clopidogrel when compared with placebo. 2) Short-term administration does not alter in vitro platelet aggregation responses to aspirin and clopidogrel when compared with placebo.
- Conditions
- Healthy Subjects
- Being tested
- Recombinant human erythropoietin alfa (drug), Aspirin (drug), Clopidogrel (drug)
- Keywords
- Platelet function tests, Erythropoietin, Aspirin, Clopidogrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human erythropoietin alfa (drug)Drug
Aspirin (drug)Drug
Clopidogrel (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding time
Platelet function assay closure time
Secondary outcomes (5)
Complete Blood Count
PT
PTT
P-selectin
von Willebrand factor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2006 (estimated)
- Study startOct 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 96 participants
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Investigators
- Stuart D Katz, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368238
- Sponsor's protocol ID
- 0506000139
- Other IDs
- AHA 0555844T
- Status last verified
- Aug 2006
- First submitted
- 23 Aug 2006
- Last updated
- 24 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00368238
- Acronym / sponsor ID
- 0506000139
- Conditions
- Healthy Subjects
- Keywords
- Platelet function tests, Erythropoietin, Aspirin, Clopidogrel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Oct 2005
- Study completion
- Jul 2006
- First posted
- 24 Aug 2006 (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 a naturally-occurring hormone called erythropoietin changes the action of platelets in the blood. Erythropoietin is made by the kidneys to stimulate red blood cell production to prevent anemia. Platelets are small cells in the blood that help clot blood in case of injury. Platelets also sometimes form blood clots in blood vessels that may cause heart attacks. This study is trying to determine whether erythropoietin increases the clotting action of platelets. Information on erythropoietin in healthy subjects may eventually help in the treatment of patients with heart attacks.
Detailed description
Anti-apoptotic effects of erythropoietin in experimental myocardial infarction and ischemia-reperfusion injury suggest potential for therapeutic benefit in patients with acute MI. Before the therapeutic potential of rHuEpo in acute MI can be tested in large clinical trials, more information on the effects of short-term rHuEpo on platelet function are needed. Accordingly, the current proposal aims to determine the effects of 3 doses of rHuEpo (100U/kg, 200U/kg and 400U/kg daily for 3 days) on platelet function and other safety measures in healthy subjects.
Specific Aim: To determine the effects of three ascending doses of rHuEpo vs. placebo on in vivo and in vitro platelet function in healthy subjects treated with aspirin and clopidogrel.
Hypotheses to be tested: 1) 1) Short-term administration of rHuEpo does not alter bleeding time responses to aspirin and clopidogrel when compared with placebo. 2) Short-term administration does not alter in vitro platelet aggregation responses to aspirin and clopidogrel when compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 21-40 years
- Able and willing to provide written informed consent
- Bleeding time <10 minutes
Key exclusion criteria (5 listed)
- Any chronic medical disease
- Chronic or frequent over-the-counter or prescription medication use
- Hemoglobin >15 gm/dl for both genders or <13 gm/dl (men) or <12 gm/dl (women)
- Platelet count >400,000/µl or <150,000/µl
- Blood pressure > 140/90 mmHg
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 |
|---|---|---|
| Recombinant human erythropoietin alfa (drug) | Drug | – |
| Aspirin (drug) | Drug | – |
| Clopidogrel (drug) | Drug | – |
Primary outcome
Bleeding time
Platelet function assay closure time
5 secondary outcomes
Complete Blood Count
PT
PTT
P-selectin
von Willebrand factor
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 Aug 2006.
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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.
Stuart D Katz, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant human erythropoietin alfa (drug), Aspirin (drug) and Clopidogrel (drug) in people with Healthy Subjects, run by Yale University at 1 site 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 24 Aug 2006. 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 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?
Bleeding time. 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 Aug 2006.