Ascending Doses of Autologous FDP vs FFP (FDP)

February 10, 2021 updated by: U.S. Army Medical Research and Development Command

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Hoxworth Blood Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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;
  • 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.

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1 unit FDP-CPD
Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD
Biological: Autologous Freeze Dried Plasma (FDP)
Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers
Experimental: Reinfusion 1 unit FDP-ACD
Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD
Biological: Autologous Freeze Dried Plasma (FDP)
Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers
Experimental: Reinfusion 2 units FDP-CPD
Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD
Biological: Autologous Freeze Dried Plasma (FDP)
Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers
Experimental: Reinfusion 2 units FDP-ACD
Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD
Biological: Autologous Freeze Dried Plasma (FDP)
Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers
Active Comparator: Reinfusion 3 units FDP, 3 units FFP (1st)
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
Biological: Autologous Freeze Dried Plasma (FDP)
Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers
Biological: Fresh Frozen Plasma (FFP)
Controlled FFP in cohort 3 only
Active Comparator: Reinfusion 3 units FDP, 3 units FFP (2nd)
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
Biological: Autologous Freeze Dried Plasma (FDP)
Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers
Biological: Fresh Frozen Plasma (FFP)
Controlled FFP in cohort 3 only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Follow-up assessments on days 2, 8, 29, and telephone assessments on days 3 and 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
U.S. Army Medical Research and Development Command

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jose A Cancelas, MD, PhD, Hoxworth Blood Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 2, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S-14-12
  • IND 17154 (Other Identifier: FDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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