Freeze Dried Plasma in Healthy VolunteersPhase 1FDPNCT02930226
Ascending Doses of Autologous FDP vs FFP
A Phase 1 study testing Autologous Freeze Dried Plasma (FDP) and Fresh Frozen Plasma (FFP) in people with Freeze Dried Plasma in Healthy Volunteers, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
Assess the safety of single infusions with RePlas FDP product at increasing fixed doses Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Freeze Dried Plasma in Healthy Volunteers
- What is being tested?
- Autologous Freeze Dried Plasma (FDP) and Fresh Frozen Plasma (FFP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2017to 2 Aug 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and non-pregnant/non-breastfeeding females;
- Minimum weight is 140 pounds, maximum weight is 220 pounds;
- Ages 18-55 years;
- Self-reports that he or she feels well and healthy;
- Scores ≥ 35 on the Duke Activity Status Index;
- Able to donate 1 unit of WB based on the AABB donor history questionnaire with modifications indicated. Subjects with history of travel which puts them at risk for Creutzfeldt-Jakob Disease (CJD) or malaria will be eligible to participate;
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- Has read the educational materials on donating blood and has had his or her questions answered;
- Able and willing to provide written informed consent;
- Available for the duration of the trial, which is approximately 12 weeks for subjects in Cohort 1 and Cohort 2, Arm 4; approximately 16 weeks for Cohort 2, Arm 3 and Cohort 3 (includes time for collections, product manufacture, and infusions), and able to come to the treatment clinic for scheduled study visits;
- Females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective, medically accepted contraceptive regimen. Highly effective methods of birth control are defined as those which result in a lower failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, or vasectomized partner;
- All females must have a negative urine pregnancy test prior to enrollment; and
- Understands the English language.
Who cannot join
- Known liver, kidney, cardiovascular, neurologic, gastrointestinal, blood, endocrine/metabolic, autoimmune or pulmonary disease, or treated or untreated hypertension;
- Cancer of any kind, under treatment or resolved;
- Known or past coagulopathy conditions;
- Any conditions, medications, etc. on the AABB medical deferral list;
- Past history of asthma (defined as use of a prescribed daily asthma controller medication or required asthma medication in the past 2 weeks);
- Past diagnosis of stroke, deep vein thrombosis, or transient ischemic attack
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- Family history of venous or arterial thrombosis before the age of 50 in first-degree relatives (i.e., biological parents, full siblings, or children);
- History of abnormal electrocardiogram (EKG);
- Current smoker (defined as having smoked within the last 6 months);
- Known Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)-related illness or received a positive test result for HIV infection;
- Positive test for Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) or Human T-cell Lymphotropic Virus (HTLV);
- History or significant treated or untreated mental health issues;
- Female subject who is pregnant, lactating, or with a positive pregnancy test;
- Currently taking an antibiotic or another medication for an infection;
- Treatment or use of aspirin (or other platelet inhibiting agents) within 14 days of study donation and infusion visits;
- Currently using any medications for anticoagulant therapy;
- Previous use of clotting factor concentrate(s);
- Receipt of blood or blood products within the past 12 months;
- In the past week, has had a headache and fever at the same time;
- Known intolerance to any excipients (citrate) in the study drug formulation;
- Systolic blood pressure greater than 140 mmHg;
- Diastolic blood pressure greater than 90 mmHg;
- Temperature greater than 100°F;
- Known hematocrit less than 38% for both male and female donors;
- Positive direct antiglobulin test (DAT);
- Treatment with any investigational agent within 1 month before treatment infusion for this trial;
- Participation in any phase of any other investigational trials while participating in this trial;
- Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule;
- Other unspecified reasons that, in the opinion of the PI, make the subject unsuitable for enrollment; or
- Institutionalized because of legal or regulatory order.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Center, Partial Double-Blind, Randomized, Controlled (Versus Fresh Frozen Plasma [FFP] in Cohort 3 Only) Clinical Study of the Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers
Assess the safety of single infusions with RePlas FDP product at increasing fixed doses
Read the detailed description
This is a single-site, partial double-blind study in healthy volunteers designed to assess the safety of infusing ascending doses of reconstituted autologous freeze dried plasma (FDP) in 3 fixed-dose cohorts. Beginning with Cohort 1, subjects will receive a single infusion of 1 unit (approximately 270 mL) of either FDP manufactured from fresh frozen plasma (FFP) derived from autologous whole blood (WB) collection(s) that use citrate phosphate dextrose (CPD) as the anticoagulant (FDP-CPD) or FDP manufactured from FFP units from autologous plasmapheresis where acid citrate dextrose (ACD) is used as the anticoagulant (FDP-ACD). Recruitment of subjects for Cohort 2 follows the completion of infusions in Cohort 1. Subjects in Cohort 2 will receive a single infusion of 2 units (approximately 540 mL) of either FDP-CPD or FDP-ACD before recruitment for Cohort 3 is initiated. Subjects enrolled in Cohort 3 will receive the highest study dose, a plasma infusion dose of 3 units (approximately 810 mL) of FDP-ACD at one infusion visit and the same dose of autologous FFP at another infusion visit. Cohort 3 subjects will only be infused with FDP and FFP products sourced from autologous plasmapheresis. Randomization of Cohort 3 subjects to a treatment sequence determines whether they will be infused with 3 units of FDP or 3 units of FFP at their first infusion visit followed by infusion with the alternate product at the second infusion visit. A 2-week interval will be maintained between infusion visits in Cohort 3. Crossover of FDP and FFP enables comparison of infusion safety and select coagulation factor recoveries within the same subjects between FDP and FFP at this higher dose.
- Being tested
- Autologous Freeze Dried Plasma (FDP), Fresh Frozen Plasma (FFP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Freeze Dried Plasma (FDP)Biological
Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers
Fresh Frozen Plasma (FFP)Biological
Controlled FFP in cohort 3 only
| Study group | Role | What they receive |
|---|---|---|
| 1 unit FDP-CPD | Experimental | Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD Receives: Biological: Autologous Freeze Dried Plasma (FDP) |
| Reinfusion 1 unit FDP-ACD | Experimental | Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD Receives: Biological: Autologous Freeze Dried Plasma (FDP) |
| Reinfusion 2 units FDP-CPD | Experimental | Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD Receives: Biological: Autologous Freeze Dried Plasma (FDP) |
| Reinfusion 2 units FDP-ACD | Experimental | Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD Receives: Biological: Autologous Freeze Dried Plasma (FDP) |
| Reinfusion 3 units FDP, 3 units FFP (1st) | Active comparator | Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits Receives: Biological: Autologous Freeze Dried Plasma (FDP); Biological: Fresh Frozen Plasma (FFP) |
| Reinfusion 3 units FDP, 3 units FFP (2nd) | Active comparator | Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits Receives: Biological: Autologous Freeze Dried Plasma (FDP); Biological: Fresh Frozen Plasma (FFP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Single Infusions of FDP at Increasing Fixed Doses in Normal Healthy Subjects by Evaluating Vital Signs and Laboratory Tests
Assess the safety of single infusions of FDP at increasing fixed doses of either 1 unit, 2 units, or 3 units in normal healthy subjects by evaluating vital signs during and after infusion
Measured: Follow-up assessments on days 2, 8, 29, and telephone assessments on days 3 and 4
Secondary outcomes (4)
Number of Participants With Treatment-emergent Adverse Events
Assess the safety and tolerability of a fixed-dose infusion of 3 FDP units in comparison to infusion with the same dose of autologous Fresh Frozen Plasma (FFP) in normal healthy subjects by evaluating vital signs and laboratory tests
Measured: Follow-up assessments on days 2, 8, 16, 22, 43, and telephone assessments on days 3, 4, 17, and 18
Number of Participants With Significant Changes in Specific Coagulation Values
Determine if the changes in specific coagulation values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. Blood thrombin, Coombs direct test, Fibrin D dimer, and Thrombin-antithrombin III levels are determined through a blood test to check if your blood is clotting normally. Positive tests or any values below or above the normal reference range is considered abnormal.
Measured: For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.
Number of Participants With Significant Changes in Specific Hematology Values
Determine if the changes in specific hematology values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. The specific hematology values are determined through a blood test. Any values below or above the normal reference range is considered abnormal.
Measured: For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.
Number of Participants With Significant Changes in Specific Chemistry Values
Determine if the changes in specific chemistry values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. Glucose levels and liver function levels, ALT and AST, are determined through a blood test. Any values below or above the normal reference range is considered abnormal.
Measured: For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study start13 Feb 2017
- Primary completion2 Aug 2018
- Study completion2 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Freeze Dried Plasma in Healthy VolunteersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jose A Cancelas, MD, PhD, Principal investigator, Hoxworth Blood Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930226
- Sponsor's protocol ID
- S-14-12
- Other IDs
- IND 17154
- Acronym
- FDP
- Status last verified
- Feb 2021
- First submitted
- 6 Oct 2016
- Last updated
- 12 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Partial Double-Blind, Randomized, Controlled (Versus Fresh Frozen Plasma [FFP] in Cohort 3 Only) Clinical Study of the Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02930226
- Acronym / sponsor ID
- FDP / S-14-12
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Posted 24 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the safety of single infusions with RePlas FDP product at increasing fixed doses
Detailed description
This is a single-site, partial double-blind study in healthy volunteers designed to assess the safety of infusing ascending doses of reconstituted autologous freeze dried plasma (FDP) in 3 fixed-dose cohorts. Beginning with Cohort 1, subjects will receive a single infusion of 1 unit (approximately 270 mL) of either FDP manufactured from fresh frozen plasma (FFP) derived from autologous whole blood (WB) collection(s) that use citrate phosphate dextrose (CPD) as the anticoagulant (FDP-CPD) or FDP manufactured from FFP units from autologous plasmapheresis where acid citrate dextrose (ACD) is used as the anticoagulant (FDP-ACD). Recruitment of subjects for Cohort 2 follows the completion of infusions in Cohort 1. Subjects in Cohort 2 will receive a single infusion of 2 units (approximately 540 mL) of either FDP-CPD or FDP-ACD before recruitment for Cohort 3 is initiated. Subjects enrolled in Cohort 3 will receive the highest study dose, a plasma infusion dose of 3 units (approximately 810 mL) of FDP-ACD at one infusion visit and the same dose of autologous FFP at another infusion visit. Cohort 3 subjects will only be infused with FDP and FFP products sourced from autologous plasmapheresis. Randomization of Cohort 3 subjects to a treatment sequence determines whether they will be infused with 3 units of FDP or 3 units of FFP at their first infusion visit followed by infusion with the alternate product at the second infusion visit. A 2-week interval will be maintained between infusion visits in Cohort 3. Crossover of FDP and FFP enables comparison of infusion safety and select coagulation factor recoveries within the same subjects between FDP and FFP at this higher dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 unit FDP-CPD | Experimental | Biological: Autologous Freeze Dried Plasma (FDP)Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD |
| Reinfusion 1 unit FDP-ACD | Experimental | Biological: Autologous Freeze Dried Plasma (FDP)Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD |
| Reinfusion 2 units FDP-CPD | Experimental | Biological: Autologous Freeze Dried Plasma (FDP)Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD |
| Reinfusion 2 units FDP-ACD | Experimental | Biological: Autologous Freeze Dried Plasma (FDP)Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD |
| Reinfusion 3 units FDP, 3 units FFP (1st) | Active comparator | Biological: Autologous Freeze Dried Plasma (FDP), Biological: Fresh Frozen Plasma (FFP)Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits |
| Reinfusion 3 units FDP, 3 units FFP (2nd) | Active comparator | Biological: Autologous Freeze Dried Plasma (FDP), Biological: Fresh Frozen Plasma (FFP)Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Males and non-pregnant/non-breastfeeding females;
- Minimum weight is 140 pounds, maximum weight is 220 pounds;
- Ages 18-55 years;
- Self-reports that he or she feels well and healthy;
- Scores ≥ 35 on the Duke Activity Status Index;
Key exclusion criteria (30 listed)
- Known liver, kidney, cardiovascular, neurologic, gastrointestinal, blood, endocrine/metabolic, autoimmune or pulmonary disease, or treated or untreated hypertension;
- Cancer of any kind, under treatment or resolved;
- Known or past coagulopathy conditions;
- Any conditions, medications, etc. on the AABB medical deferral list;
- Past history of asthma (defined as use of a prescribed daily asthma controller medication or required asthma medication in the past 2 weeks);
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 |
|---|---|---|
| Autologous Freeze Dried Plasma (FDP)Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers | Biological | 1 unit FDP-CPD, Reinfusion 1 unit FDP-ACD, Reinfusion 2 units FDP-ACD, Reinfusion 2 units FDP-CPD, Reinfusion 3 units FDP, 3 units FFP (1st), Reinfusion 3 units FDP, 3 units FFP (2nd) |
| Fresh Frozen Plasma (FFP)Controlled FFP in cohort 3 only | Biological | Reinfusion 3 units FDP, 3 units FFP (1st), Reinfusion 3 units FDP, 3 units FFP (2nd) |
Primary outcome
Safety of Single Infusions of FDP at Increasing Fixed Doses in Normal Healthy Subjects by Evaluating Vital Signs and Laboratory Tests
Time frame: Follow-up assessments on days 2, 8, 29, and telephone assessments on days 3 and 4
Assess the safety of single infusions of FDP at increasing fixed doses of either 1 unit, 2 units, or 3 units in normal healthy subjects by evaluating vital signs during and after infusion
4 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events
Time frame: Follow-up assessments on days 2, 8, 16, 22, 43, and telephone assessments on days 3, 4, 17, and 18
Number of Participants With Significant Changes in Specific Coagulation Values
Time frame: For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.
Number of Participants With Significant Changes in Specific Hematology Values
Time frame: For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.
Number of Participants With Significant Changes in Specific Chemistry Values
Time frame: For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Jose A Cancelas, MD, PhD principal investigator
Hoxworth Blood Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Freeze Dried Plasma (FDP) and Fresh Frozen Plasma (FFP) in people with Freeze Dried Plasma in Healthy Volunteers, run by U.S. Army Medical Research and Development Command at 1 site in United States.
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 12 inclusion and 30 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 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety of Single Infusions of FDP at Increasing Fixed Doses in Normal Healthy Subjects by Evaluating Vital Signs and Laboratory Tests (time frame: Follow-up assessments on days 2, 8, 29, and telephone assessments on days 3 and 4). 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 12 Feb 2021.