BleedingNCT04619108
Thrombosomes for Expanded Access Use
A study testing Thrombosomes® in people with Bleeding, run by Cellphire Therapeutics, Inc..
Trial summary
Expanded use of Thrombosomes where a clinical trial with Thrombosomes is not an option, Cellphire may elect to provide the Sponsor/Investigator (S/I) expanded access to its investigational product, Thrombosomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding
- What is being tested?
- Thrombosomes®
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Subject has presented with WHO Grade 2 or higher bleeding which requires treatment with platelet therapy and there is limited availability of platelets or no other approved clinical alternative.
- Evidence from the facility blood bank/Medical Director that there are no approved platelet products available for transfusion, or the patient is refractory to platelet transfusion.
Who cannot join
- Clinical circumstances of a history of thrombosis, thromboembolism, or vascular occlusion/ischemia in the prior six months such as defined by a past history of current diagnosis of one or more of the following:
- arterial or venous thromboembolic disease including acute coronary syndrome
- peripheral vascular disease
- arterial or venous thrombosis (except when a prior history of central line thrombosis has resolved)
- myocardial infarction (MI)
- stent placement
- valve replacement and/or repair
- sinusoidal obstruction syndrome (veno-occlusive disease)
About this study
Expanded use of Thrombosomes where a clinical trial with Thrombosomes is not an option, Cellphire may elect to provide the Sponsor/Investigator (S/I) expanded access to its investigational product, Thrombosomes.
- Conditions
- Bleeding
- Being tested
- Thrombosomes®
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombosomes®Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Cellphire Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619108
- Sponsor's protocol ID
- Thrombosomes Expanded Access
- Status last verified
- Mar 2024
- First submitted
- 2 Nov 2020
- Last updated
- 21 Mar 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombosomes for Expanded Access Use
- ClinicalTrials.gov ID
- NCT04619108
- Acronym / sponsor ID
- Thrombosomes Expanded Access
- Conditions
- Bleeding
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Cellphire Therapeutics, Inc.Industry (pharma, biotech, devices)
- First posted
- 6 Nov 2020 (actual)
- 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.
Expanded use of Thrombosomes where a clinical trial with Thrombosomes is not an option, Cellphire may elect to provide the Sponsor/Investigator (S/I) expanded access to its investigational product, Thrombosomes.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has presented with WHO Grade 2 or higher bleeding which requires treatment with platelet therapy and there is limited availability of platelets or no other approved clinical alternative.
- Evidence from the facility blood bank/Medical Director that there are no approved platelet products available for transfusion, or the patient is refractory to platelet transfusion.
Key exclusion criteria (8 listed)
- Clinical circumstances of a history of thrombosis, thromboembolism, or vascular occlusion/ischemia in the prior six months such as defined by a past history of current diagnosis of one or more of the following:
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 |
|---|---|---|
| Thrombosomes® | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
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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 study testing Thrombosomes® in people with Bleeding, run by Cellphire Therapeutics, Inc..
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 2 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. 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.
Are results available for this study?
Results are not available in the source record.
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.
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 21 Mar 2024.