ThrombocytopeniaEarly Phase 1NCT00263809
Safety and Performance of MIRASOL® PRT Treated Platelet Transfusion Products
A Early Phase 1 study testing Pathogen Reduction Technology in people with Thrombocytopenia, run by Terumo BCTbio at 10 sites in France.
Trial summary
The primary objective of the study is to measure platelet corrected count increments and the incidence of serious adverse events (SAE). The primary endpoint is the platelet corrected count increment measured 1-hour post transfusion in response to the infusion of platelet concentrates treated with the Mirasol PRT… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Pathogen Reduction Technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 10 sitesFrance
- Study dates
- Dec 2005to Oct 2007
- Phase
- Early Phase 1
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female of age of 16 years or older
- Women of Child Bearing Potential not pregnant
- Subject must have signed and dated the Informed Consent form
- Hospitalized, thrombocytopenic subjects and expected to receive at least two platelets transfusion
Who cannot join
- History of any hypersensitivity reaction to riboflavin or metabolites
- History of refractoriness to platelet transfusions
- Positive lymphocytotoxic antibody test
- Active bleeding
- Splenomegaly
- Acute or chronic Disseminated Intravascular Coagulation
Show all 14Show fewer
- History or diagnosis of Immune/Idiopathic Thrombocytopenic Purpura, Thrombotic Thrombocytopenia Purpura, or Haemolytic Uremic Syndrome
- History or diagnosis of an autoimmune disease affecting haemostasis
- History of solid organ transplants
- Evidence of occlusive venous disease
- Clinical signs of infection at the time of inclusion
- Pregnant or lactating females
- Chronic alcohol misuse
- Use of prohibited medications
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Centre Hospitalier Universitaire Jean Minjoz
Besançon, 25020
EFS Bourgogne - Franche-Comté
Besançon, 25020
EFS Aquitaine
Bordeaux, 33035
Centre Hospitalier Univesrsitaire A Michallon
La Tronche, 38043
EFS Rhône-Alpes (Site de Grenoble)
La Tronche, 38701
EFS Pays de la Loire
Nantes, 44011
Centre Hospitalier Universitaire Hôtel Dieu
Nantes, 44035
Centre Hospitalier Universitaire de Bordeaux
Pessac, 33604
Centre Hospitalier Régional Universitaire Hautepierre
Strasbourg, 67000
EFS Alsace
Strasbourg, 67065
About this study
Official title: Evaluation of the Safety and Performance of Platelet Transfusion Products Treated With MIRASOL® Pathogen Reduction Technology. A Study in Human Thrombocytopenic Subjects.
The primary objective of the study is to measure platelet corrected count increments and the incidence of serious adverse events (SAE). The primary endpoint is the platelet corrected count increment measured 1-hour post transfusion in response to the infusion of platelet concentrates treated with the Mirasol PRT System device (test product) versus untreated (reference product).
Read the detailed description
The objective of the study is to determine if the MIRASOL Pathogen Reduction Technology (PRT) System for Platelets device performs safely and maintains adequate platelet performance in a clinical setting. This will be achieved by comparing the platelet corrected count increment measured 1 hour post transfusion and the incidence of serious adverse events in response to the infusion of platelet concentrates treated with the device (test product) versus untreated (reference product) in thrombocytopenic subjects requiring platelet transfusions. The performance, safety, and tolerability profile of the device will be further assessed by monitoring and comparing the incidence of discontinuations due to adverse events in relation to platelet transfusion up to 4 weeks after transfusion, including the incidence of transfusion associated infections, and the number and time between transfusions.
- Conditions
- Thrombocytopenia
- Being tested
- Pathogen Reduction Technology
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathogen Reduction TechnologyDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment, Mirasol-treated platelets Receives: Device: Pathogen Reduction Technology |
| 2 | No intervention | Reference, Untreated platelets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The platelet corrected count increment measured 1 hour post transfusion.
Secondary outcomes (11)
The platelet corrected count increment measured 24 hours post-transfusion.
The number of days between platelet transfusions during the period of the study.
The number of platelet transfusions per subject.
The number of platelets infused per subject.
The number of platelets used.
The frequency of refractoriness to platelet transfusion.
In case of refractoriness, the evidence for neoantigen immunization against test product.
The number of red blood cell transfusions during the study period.
The incidence of serious adverse events in relation to platelet transfusions.
The incidence of any adverse events in relation to platelet transfusions.
The occurrence of bleeding episodes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo BCTbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean-Pierre Cazenave, MD, Principal investigator, Director - EFS Alsace - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263809
- Sponsor's protocol ID
- CTS-0028
- Status last verified
- Oct 2009
- First submitted
- 7 Dec 2005
- Last updated
- 7 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Performance of Platelet Transfusion Products Treated With MIRASOL® Pathogen Reduction Technology. A Study in Human Thrombocytopenic Subjects.
- ClinicalTrials.gov ID
- NCT00263809
- Acronym / sponsor ID
- CTS-0028
- Conditions
- Thrombocytopenia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Terumo BCTbioIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 9 Dec 2005 (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 primary objective of the study is to measure platelet corrected count increments and the incidence of serious adverse events (SAE). The primary endpoint is the platelet corrected count increment measured 1-hour post transfusion in response to the infusion of platelet concentrates treated with the Mirasol PRT System device (test product) versus untreated (reference product).
Detailed description
The objective of the study is to determine if the MIRASOL Pathogen Reduction Technology (PRT) System for Platelets device performs safely and maintains adequate platelet performance in a clinical setting. This will be achieved by comparing the platelet corrected count increment measured 1 hour post transfusion and the incidence of serious adverse events in response to the infusion of platelet concentrates treated with the device (test product) versus untreated (reference product) in thrombocytopenic subjects requiring platelet transfusions. The performance, safety, and tolerability profile of the device will be further assessed by monitoring and comparing the incidence of discontinuations due to adverse events in relation to platelet transfusion up to 4 weeks after transfusion, including the incidence of transfusion associated infections, and the number and time between transfusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Pathogen Reduction TechnologyTreatment, Mirasol-treated platelets |
| 2 | No intervention | –Reference, Untreated platelets |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female of age of 16 years or older
- Women of Child Bearing Potential not pregnant
- Subject must have signed and dated the Informed Consent form
- Hospitalized, thrombocytopenic subjects and expected to receive at least two platelets transfusion
Key exclusion criteria (14 listed)
- History of any hypersensitivity reaction to riboflavin or metabolites
- History of refractoriness to platelet transfusions
- Positive lymphocytotoxic antibody test
- Active bleeding
- Splenomegaly
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 |
|---|---|---|
| Pathogen Reduction Technology | Device | 1 |
Primary outcome
The platelet corrected count increment measured 1 hour post transfusion.
11 secondary outcomes
The platelet corrected count increment measured 24 hours post-transfusion.
The number of days between platelet transfusions during the period of the study.
The number of platelet transfusions per subject.
The number of platelets infused per subject.
The number of platelets used.
The frequency of refractoriness to platelet transfusion.
In case of refractoriness, the evidence for neoantigen immunization against test product.
The number of red blood cell transfusions during the study period.
The incidence of serious adverse events in relation to platelet transfusions.
The incidence of any adverse events in relation to platelet transfusions.
The occurrence of bleeding episodes.
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 7 Oct 2009.
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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.
Jean-Pierre Cazenave, MD principal investigator
Director - EFS Alsace - France
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pathogen Reduction Technology in people with Thrombocytopenia, run by Terumo BCTbio at 10 sites in France.
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 4 inclusion and 14 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 7 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The platelet corrected count increment measured 1 hour post transfusion.. 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 7 Oct 2009.