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Plasma

FrontlineODP™ Spray Dried Plasma for Blood Clotting Disorders

Phase 1
Recruiting
Research Sponsored by Velico Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females must weigh between 140-220 pounds; males must weigh between 140-250 pounds
Subject is 18 to 65 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of first plasma infusion through 28-day follow up of second infusion (day 43).
Awards & highlights

Study Summary

This trial tests if a new medical treatment is safe. It looks at how well the body reacts to increasing doses of a special medical product.

Who is the study for?
Healthy volunteers aged 18-65 who can consent, understand English, have completed COVID-19 vaccination, and meet specific weight requirements. Women must not be pregnant/breastfeeding and should use effective contraception or be sterile. Participants must feel well and score ≥35 on the Duke Activity Status Index.Check my eligibility
What is being tested?
The trial is testing FrontlineODP™ Spray Dried Plasma in healthy individuals to see if different doses are safe when infused into the body. It's for people with bleeding or blood clotting disorders.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, allergic responses, changes in blood pressure or heart rate, dizziness, headache, nausea or other symptoms related to plasma transfusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a female weighing between 140-220 pounds or a male weighing between 140-250 pounds.
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I am between 18 and 65 years old.
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I am not pregnant.
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I am using effective birth control or am surgically sterile.
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I have a score of 35 or higher on the Duke Activity Status Index.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of first plasma infusion through 28-day follow up of second infusion (day 43).
This trial's timeline: 3 weeks for screening, Varies for treatment, and start of first plasma infusion through 28-day follow up of second infusion (day 43). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Secondary outcome measures
Changes in D-dimer
Changes in Factor I
Changes in Factor II
+13 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 2Experimental Treatment1 Intervention
Subjects are to have sufficient plasma withdrawn during a single plasmapheresis collection, in the range of 625 - 800 mL, depending on subject's weight and hematocrit, to allow re-infusion with 2 units (400 mL) of autologous FrontlineODP.
Group II: Cohort 1Experimental Treatment1 Intervention
Subjects are to have sufficient plasma withdrawn during a single plasmapheresis collection in the range of 625 - 800 mL, depending on subject's weight and hematocrit, to allow re-infusion with 1 unit (200 mL) of autologous FrontlineODP.
Group III: Cohort 3 Arm 3Active Control1 Intervention
Subject plasma is withdrawn during 4 plasmapheresis collections, in the range of 625 - 800 mL per collection, a total of approximately 2500 - 3200 mL, depending on subject's weight and hematocrit, to allow re-infusion with 4 units of autologous FrontlineODP and 4 units of autologous control PF24. Subjects will receive in total 8 units of plasma over the course of 2 infusion visits. Subjects randomized to Arm 3 will receive 4 units of FrontlineODP during the first infusion visit, and following a 14 day washout period, they would receive 4 units of PF24 during a second visit.
Group IV: Cohort 3 Arm 4Active Control1 Intervention
Subject plasma is withdrawn during 4 plasmapheresis collections, in the range of 625 - 800 mL per collection, a total of approximately 2500 - 3200 mL, depending on subject's weight and hematocrit, to allow re-infusion with 4 units of autologous control PF24 and 4 units of autologous FrontlineODP. Subjects will receive in total 8 units of plasma over the course of 2 infusion visits. Subjects randomized to Arm 4 will receive 4 units of PF24 during the first infusion visit, and following a 14 day washout period, they would receive 4 units of FrontlineODP during the second visit.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Velico MedicalLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
Mark Popovsky, MDStudy DirectorVelico Medical

Media Library

FrontlineODP™ Spray Dried Plasma (Plasma) Clinical Trial Eligibility Overview. Trial Name: NCT05629338 — Phase 1
Bleeding Research Study Groups: Cohort 1, Cohort 2, Cohort 3 Arm 3, Cohort 3 Arm 4
Bleeding Clinical Trial 2023: FrontlineODP™ Spray Dried Plasma Highlights & Side Effects. Trial Name: NCT05629338 — Phase 1
FrontlineODP™ Spray Dried Plasma (Plasma) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05629338 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is geriatric participation being taken into account for this clinical research?

"The requirements for entry into this clinical trial dictate that participants must be aged 18 or older but no more than 65 years old."

Answered by AI

Are volunteers being accepted at this time for the clinical trial?

"According to the information published on clinicaltrials.gov, this medical trial is not presently recruiting patients. The original posting date was December 1st 2022 and it has since been amended with changes made as recently as November 29th 2022. Nevertheless, there are currently 375 other trials actively searching for participants."

Answered by AI

Are there any criteria that must be met for people to qualify for this experiment?

"The requirements for enrolment into this trial are a diagnosis of coagulation disorder and an age between 18-65. The study is seeking 24 participants in total."

Answered by AI

Does Cohort 2 present any foreseeable risks to participants?

"As this is a Phase 1 trial, the level of safety for Cohort 2 has been tentatively rated as 1 due to limited data available regarding its efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ascending Dose Study of FrontlineODP™ Spray Dried Plasma
2022. "Ascending Dose Study of FrontlineODP™ Spray Dried Plasma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05629338.
~0 spots leftby May 2024
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