HealthyPhase 2NCT02310412
A Controlled, In Vivo, Pilot Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Treated 7-Day Stored Apheresis Platelet Components in 35% Plasma and 65% InterSol and 7-Day Stored Apheresis Platelet Components in 100% Plasma
A Phase 2 study testing INTERCEPT treated platelets in people with Healthy, run by Cerus Corporation.
Trial summary
The objective of this study is to test the hypothesis that INTERCEPT platelet components stored for 7 days retain sufficient viability for therapeutic efficacy. The post-infusion recovery and lifespan of 7-day old INTERCEPT platelet components stored in 35% plasma and 65% InterSol or stored in 100% plasma, will be… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- INTERCEPT treated platelets
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Sep 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age-minimum of 18 years, of either gender
- Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
- Meet FDA and AABB guidelines for autologous apheresis platelet donation
- Complete blood count (CBC) and serum chemistry values within normal limits
- Pre-donation platelet count of more than 150×109 platelets/L
- Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, syphilis, and WNV
- Male and female subjects of childbearing potential must agree to use a medically acceptable method of contraception throughout the study. A barrier method of contraception must be included, regardless of other methods.
- Signed and dated informed consent form
Who cannot join
- Clinically significant acute or chronic disease (as determined by the Investigator)
- Pregnant or nursing females
- Male or female subjects of childbearing potential not using effective contraception
- Disease states or conditions that preclude blood donation or apheresis platelet donation per AABB reference standards
- Treatment with aspirin or aspirin containing medications within 7 days of apheresis or treatment with non-steroidal anti-inflammatory drugs (NSAID), anti-platelet agents or other drugs affecting platelet viability within 3 days of apheresis (e.g. ibuprofen or other NSAIDs)
- Smokers using >10 cigarettes/day for the last 3 months
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- Splenectomized subjects
- Prior exposure to amotosalen
- History of known hypersensitivity to indium or chromium
- Participation in another clinical study currently or within the past 28 days
About this study
The objective of this study is to test the hypothesis that INTERCEPT platelet components stored for 7 days retain sufficient viability for therapeutic efficacy. The post-infusion recovery and lifespan of 7-day old INTERCEPT platelet components stored in 35% plasma and 65% InterSol or stored in 100% plasma, will be measured in comparison to "fresh" radiolabeled platelets according to FDA guidance for platelet testing (FDA 1999).
Read the detailed description
The two stages of this pilot study consist of the following: single or double-dose platelet apheresis collection, pathogen inactivation with INTERCEPT treatment, storage for 7 days, collection of fresh platelets, radiolabeling, infusion of fresh and stored INTERCEPT treated radiolabeled autologous platelets, and collection of blood samples for assessment of platelet recovery and survival (lifespan).
In Stage A, apheresis platelets will be collected using the Amicus separator and stored for 7 days in 35% Plasma and 65% InterSol.
In Stage B, apheresis platelets will be collected using the Trima separator and stored for 7 days in 100% plasma.
Procedures for both stages will be as follows: On Day 0, each healthy volunteer subject has apheresis platelets collected. INTERCEPT treatment will begin on either the day of donation (Day 0) or before the end of the day following donation (Day 1). Platelets will then be stored for 7 days after collection (Day 7). Aliquots for in vitro platelet function will be taken on Day 0/1 after INTERCEPT treatment and Day 7. An aliquot for bacterial detection will be taken on Day 5.
On Day 7, healthy volunteers will return to the laboratory, and 43 mL of blood will be drawn into a syringe containing 9 mL of Anticoagulant Citrate Dextrose Solution, Formula A (ACD-A). Fresh platelets will be prepared from this sample. An aliquot (10-20 mL) of the stored (INTERCEPT treated) platelets will be aseptically removed from each subject's test container. Previously stored (Test) and fresh (Control) platelets will be radiolabeled according to randomization assignment with either 51Cr (≤20 μCi) as sodium radiochromate (Na251CrO4), or 111In (≤15 μCi) as indium oxine, following the labeling and washing procedures outlined by the Biomedical Excellence for Safer Transfusion (BEST) Collaborative. The isotope labels will be determined by a random number table such that equal numbers of fresh and stored (INTERCEPT treated) platelets will be labeled with each isotope. Aliquots of the fresh and stored platelets will be radiolabeled in tubes with the standard techniques. After radiolabeling, the autologous fresh and stored platelets will be simultaneously infused into the subject (approximately 10-30 mL). Negative bacteria detection test and negative pregnancy test for females of childbearing potential are required before infusion.
Blood samples for radioactivity measurements will be drawn at 0 (pre-infusion), 0.5, 1, and 2 hours post-infusion, and then 6 more samples will be drawn 1, 2, 3, 4 (or 6), 7±1, and 10±1 days post-infusion. In addition, when logistically feasible, an additional sample will be obtained 5 days post-infusion (optional).
Radioactivity measurements Samples will be obtained from the radiolabeled fresh and stored platelets before infusion and used as a radioactive standard. By measuring the volume infused, the total dose of radioactivity infused will be calculated. In vitro elution of the label from the transfused platelets will be determined by two elution assessment methods, as well as the in vivo elution of radioactivity from the serial blood samples obtained post-infusion of the labeled platelets.
The standard as well as the subject's whole-blood samples will be corrected for elution and also for the residual activity in the cellular fraction on Day 8. The first four data points post-infusion will be used to calculate in vivo recoveries and survivals after all radioactive corrections have been made. The radioactivity of the samples will be determined by use of a gamma counter. A multiple-hit model, with a computerized program "COST," will be used to estimate the recovery and survival of the radioactively labeled platelets.
- Conditions
- Healthy
- Being tested
- INTERCEPT treated platelets
- Keywords
- INTERCEPT, platelet, pathogen inactivation, platelet components stored, therapeutic efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTERCEPT treated plateletsBiological
| Study group | Role | What they receive |
|---|---|---|
| Amicus platelet components | Experimental | The two stages of this pilot study consist of the following: single or double dose platelet apheresis collection, pathogen inactivation with INTERCEPT treatment, storage for 7 days, collection of fresh platelets, radiolabeling, infusion of fresh and stored INTERCEPT treated radiolabeled autologous platelets, and collection of blood samples for assessment of platelet recovery and survival (lifespan). In Stage 1, apheresis platelets will be collected using the Amicus separator and stored for 7 days in 35% Plasma and 65% InterSol Receives: Biological: INTERCEPT treated platelets |
| Trima platelet components | Experimental | The two stages of this pilot study consist of the following: single or double dose platelet apheresis collection, pathogen inactivation with INTERCEPT treatment, storage for 7 days, collection of fresh platelets, radiolabeling, infusion of fresh and stored INTERCEPT treated radiolabeled autologous platelets, and collection of blood samples for assessment of platelet recovery and survival (lifespan). In Stage 2, apheresis platelets will be collected using the Trima separator and stored for 7 days in 100% plasma. Receives: Biological: INTERCEPT treated platelets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post infusion recovery ratio of Test platelets at Day 7 compared to fresh platelets
Measured: Day 7
Post infusion lifespan ratio of Test platelets at Day 7 compared to fresh platelets
Measured: Day 7
In vitro pH at Day 7
Measured: Day 7
Adverse events, vital signs, hematological profile and serum chemistry profile
Measured: Days 0 to 17
Secondary outcomes (4)
Product parameters
Platelet count, platelet dose, mean platelet volume (MPV), morphology score, and volume
Measured: Day 7
Biochemical assessments
glucose, lactate pO2, pCO2, bicarbonate, and lactate dehydrogenase (LDH)
Measured: Day 7
Functional assessments
hypotonic shock response (HSR), extent of shape change (ESC), CD62 (p-selectin)expression, and ATP, % of lysis
Measured: Day 7
Bacterial contamination
A bacterial detection test of the Test component will be performed using the Pall Medical enhanced bacterial detection system (eBDS)
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMay 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerus Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310412
- Sponsor's protocol ID
- CLI 00099
- Status last verified
- Nov 2017
- First submitted
- 10 Nov 2014
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, In Vivo, Pilot Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Treated 7-Day Stored Apheresis Platelet Components in 35% Plasma and 65% InterSol and 7-Day Stored Apheresis Platelet Components in 100% Plasma
- ClinicalTrials.gov ID
- NCT02310412
- Acronym / sponsor ID
- CLI 00099
- Conditions
- Healthy
- Keywords
- INTERCEPT, platelet, pathogen inactivation, platelet components stored, therapeutic efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cerus CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Dec 2014 (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 objective of this study is to test the hypothesis that INTERCEPT platelet components stored for 7 days retain sufficient viability for therapeutic efficacy. The post-infusion recovery and lifespan of 7-day old INTERCEPT platelet components stored in 35% plasma and 65% InterSol or stored in 100% plasma, will be measured in comparison to "fresh" radiolabeled platelets according to FDA guidance for platelet testing (FDA 1999).
Detailed description
The two stages of this pilot study consist of the following: single or double-dose platelet apheresis collection, pathogen inactivation with INTERCEPT treatment, storage for 7 days, collection of fresh platelets, radiolabeling, infusion of fresh and stored INTERCEPT treated radiolabeled autologous platelets, and collection of blood samples for assessment of platelet recovery and survival (lifespan).
In Stage A, apheresis platelets will be collected using the Amicus separator and stored for 7 days in 35% Plasma and 65% InterSol.
In Stage B, apheresis platelets will be collected using the Trima separator and stored for 7 days in 100% plasma.
Procedures for both stages will be as follows: On Day 0, each healthy volunteer subject has apheresis platelets collected. INTERCEPT treatment will begin on either the day of donation (Day 0) or before the end of the day following donation (Day 1). Platelets will then be stored for 7 days after collection (Day 7). Aliquots for in vitro platelet function will be taken on Day 0/1 after INTERCEPT treatment and Day 7. An aliquot for bacterial detection will be taken on Day 5.
On Day 7, healthy volunteers will return to the laboratory, and 43 mL of blood will be drawn into a syringe containing 9 mL of Anticoagulant Citrate Dextrose Solution, Formula A (ACD-A). Fresh platelets will be prepared from this sample. An aliquot (10-20 mL) of the stored (INTERCEPT treated) platelets will be aseptically removed from each subject's test container. Previously stored (Test) and fresh (Control) platelets will be radiolabeled according to randomization assignment with either 51Cr (≤20 μCi) as sodium radiochromate (Na251CrO4), or 111In (≤15 μCi) as indium oxine, following the labeling and washing procedures outlined by the Biomedical Excellence for Safer Transfusion (BEST) Collaborative. The isotope labels will be determined by a random number table such that equal numbers of fresh and stored (INTERCEPT treated) platelets will be labeled with each isotope. Aliquots of the fresh and stored platelets will be radiolabeled in tubes with the standard techniques. After radiolabeling, the autologous fresh and stored platelets will be simultaneously infused into the subject (approximately 10-30 mL). Negative bacteria detection test and negative pregnancy test for females of childbearing potential are required before infusion.
Blood samples for radioactivity measurements will be drawn at 0 (pre-infusion), 0.5, 1, and 2 hours post-infusion, and then 6 more samples will be drawn 1, 2, 3, 4 (or 6), 7±1, and 10±1 days post-infusion. In addition, when logistically feasible, an additional sample will be obtained 5 days post-infusion (optional).
Radioactivity measurements Samples will be obtained from the radiolabeled fresh and stored platelets before infusion and used as a radioactive standard. By measuring the volume infused, the total dose of radioactivity infused will be calculated. In vitro elution of the label from the transfused platelets will be determined by two elution assessment methods, as well as the in vivo elution of radioactivity from the serial blood samples obtained post-infusion of the labeled platelets.
The standard as well as the subject's whole-blood samples will be corrected for elution and also for the residual activity in the cellular fraction on Day 8. The first four data points post-infusion will be used to calculate in vivo recoveries and survivals after all radioactive corrections have been made. The radioactivity of the samples will be determined by use of a gamma counter. A multiple-hit model, with a computerized program "COST," will be used to estimate the recovery and survival of the radioactively labeled platelets.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amicus platelet components | Experimental | Biological: INTERCEPT treated plateletsThe two stages of this pilot study consist of the following: single or double dose platelet apheresis collection, pathogen inactivation with INTERCEPT treatment, storage for 7 days, collection of fresh platelets, radiolabeling, infusion of fresh and stored INTERCEPT treated radiolabeled autologous platelets, and collection of blood samples for assessment of platelet recovery and survival (lifespan). In Stage 1, apheresis platelets will be collected using the Amicus separator and stored for 7 days in 35% Plasma and 65% InterSol |
| Trima platelet components | Experimental | Biological: INTERCEPT treated plateletsThe two stages of this pilot study consist of the following: single or double dose platelet apheresis collection, pathogen inactivation with INTERCEPT treatment, storage for 7 days, collection of fresh platelets, radiolabeling, infusion of fresh and stored INTERCEPT treated radiolabeled autologous platelets, and collection of blood samples for assessment of platelet recovery and survival (lifespan). In Stage 2, apheresis platelets will be collected using the Trima separator and stored for 7 days in 100% plasma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age-minimum of 18 years, of either gender
- Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
- Meet FDA and AABB guidelines for autologous apheresis platelet donation
- Complete blood count (CBC) and serum chemistry values within normal limits
- Pre-donation platelet count of more than 150×109 platelets/L
Key exclusion criteria (10 listed)
- Clinically significant acute or chronic disease (as determined by the Investigator)
- Pregnant or nursing females
- Male or female subjects of childbearing potential not using effective contraception
- Disease states or conditions that preclude blood donation or apheresis platelet donation per AABB reference standards
- Treatment with aspirin or aspirin containing medications within 7 days of apheresis or treatment with non-steroidal anti-inflammatory drugs (NSAID), anti-platelet agents or other drugs affecting platelet viability within 3 days of apheresis (e.g. ibuprofen or other NSAIDs)
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 |
|---|---|---|
| INTERCEPT treated platelets | Biological | Amicus platelet components, Trima platelet components |
Primary outcome
Post infusion recovery ratio of Test platelets at Day 7 compared to fresh platelets
Time frame: Day 7
Post infusion lifespan ratio of Test platelets at Day 7 compared to fresh platelets
Time frame: Day 7
In vitro pH at Day 7
Time frame: Day 7
Adverse events, vital signs, hematological profile and serum chemistry profile
Time frame: Days 0 to 17
4 secondary outcomes
Product parameters
Time frame: Day 7
Biochemical assessments
Time frame: Day 7
Functional assessments
Time frame: Day 7
Bacterial contamination
Time frame: Day 7
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 8 Nov 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INTERCEPT treated platelets in people with Healthy, run by Cerus Corporation.
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 8 inclusion and 10 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 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Post infusion recovery ratio of Test platelets at Day 7 compared to fresh platelets (time frame: Day 7). The study lists 4 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 8 Nov 2017.