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autologous stored platelets

Phase 2

Bleeding | Monoclonal antibody | Hematology |Novo Nordisk A/S|Last Updated: Apr 28, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

autologous stored platelets · 1 trial · 1 indication

Phase 2 1
NCT01248351Reversibility of Dual Antiplatelet Therapy by PlateletsBleeding
COMPLETED6 Analytics
PHASE2COMPLETED
Reversibility of Dual Antiplatelet Therapy by Platelets
BleedingUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacodynamic assessment of platelet function as assessed by 5 and 20 micromolar ADP
7 days

pharmacodynamic measurements of platelet function will be assessed at baseline, after 3 days administration of aspirin and clopidogrel (300 mg loading with aspirin and clopidogrel, maintenance with 100 mg aspirin and 75 mg clopidogrel, respectively) after retransfusion of stored platelets and 24 hours thereafter

Secondary Endpoints

Pharmacodynamic assessment of platelet function as assessed by 20 mM arachidonic acid
7 days
Pharmacodynamic assessment of platelet function as assessed by Vasodilator stimulated phosphoprotein (VASP) phosphorylation (platelet reactivity index; PRI)
7 days
Pharmacodynamic assessment of platelet function as assessed by expression of GP IIb/IIIa receptors and P-selectin (Mean fluorescence intensity %)
7 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
autologous stored plateletsEXPERIMENTAL -

Interventions

NameTypeDescription
autologous stored plateletsOTHERAdministration of autologous stored platelets
administration of autologous stored plateletsOTHERadministration of autologous stored platelets
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Eligibility Criteria

Age Range18 Years to 30 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Informed consent 2. Healthy volunteers, male or female (after exclusion of pregnancy if they are on birth control pill or have a contraceptive coil implanted) 3. Age of consent 4. Weight: 70 kg - 100 kg 5. Platelet count 240 000 to 440 000/µL 6. Hematocrit \> 40% 7. readiness...

Countries:Austria
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Frequently asked questions about autologous stored platelets

What is autologous stored platelets used for?

Autologous stored platelets is an investigational therapy being studied for bleeding. It is in Phase 2 clinical development. The approach involves using a patient's own platelets, which are stored and then potentially used to manage bleeding. It is being developed by Novo Nordisk A/S.

Who makes autologous stored platelets?

Novo Nordisk A/S (ticker: NVO) is developing autologous stored platelets. The therapy is currently in Phase 2 clinical development for bleeding. It is an investigational product and has not been approved by regulatory authorities.

What phase is autologous stored platelets in?

Autologous stored platelets is in Phase 2 clinical development. It is being studied for bleeding. The therapy is investigational and has not been approved. One Phase 2 trial has been completed, involving 6 participants.

What clinical trials is autologous stored platelets in?

Autologous stored platelets has one completed Phase 2 trial, NCT01248351, titled "Reversibility of Dual Antiplatelet Therapy by Platelets." The trial enrolled 6 participants with bleeding in Austria. It was an uncontrolled study that included healthy volunteers.

Is autologous stored platelets the same as other platelet therapies?

Autologous stored platelets refers to a patient's own platelets that are collected and stored for potential use. This approach is distinct from donor-derived platelet transfusions. The therapy is being investigated for bleeding and is in Phase 2 development by Novo Nordisk.