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Ascending Doses of Autologous FDP vs FFP (FDP)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 by U.S. Army Medical Research and Materiel Command
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT02930226
First received: October 6, 2016
Last updated: October 7, 2016
Last verified: October 2016
  Purpose
Assess the safety of single infusions with RePlas FDP product at increasing fixed doses

Condition Intervention Phase
Freeze Dried Plasma in Healthy Volunteers
Biological: Autologous Freeze Dried Plasma (FDP)
Biological: Fresh Frozen Plasma (FFP)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Safety of fixed-dose infusions of 3 FDP units in comparison to 3 FFP units in normal healthy subjects by evaluating vital signs and laboratory tests [ 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 of a fixed-dose infusion of 3 FDP units in comparison to infusion with the same dose of autologous Fresh Frozen Plasma (FFP) collected

  • Document if changes in specific coagulation values are within clinically meaningful levels pre and post infusion by evaluating laboratory tests [ 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 factors are similar with clinically meaningful levels pre and post infusion of either 3 units of FDP or FFP.

  • Document if changes in specific hematology values are within clinically meaningful levels pre and post infusion by evaluating laboratory tests [ 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 of either 3 units of FDP or FFP.

  • Document if changes in specific chemistry values are within clinically meaningful levels pre and post infusion by evaluating laboratory tests [ 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 of either 3 units of FDP or FFP.


Estimated Enrollment: 24
Study Start Date: October 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
This is a single-site, single-blind study in healthy volunteers and is designed to assess the safety of infusing ascending doses of reconstituted autologous FDP in 3 fixed-dose cohorts. Subjects in Cohort 1 will receive 1 unit of FDP, which is approximately 270 mL. Subjects in Cohort 2 will receive 2 FDP units, which total approximately 540 mL. Cohorts 1 and 2 are the lower-dose cohorts. Subjects will be assigned to these beginning with the lowest dose, Cohort 1. In the absence of SAEs or the implementation of protocol stopping rules (SRs), subjects will be assigned to Cohort 2, where the dose is increased to 2 units. For both of these cohorts subjects will also be assigned to 1 of 2 single infusion treatment arms.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02930226

Contacts
Contact: Jose A Cancelas, MD, PhD 513-558-1324 jose.cancelas@cchmc.org

Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Jose A Cancelas, MD, PhD Hoxworth Blood Center
  More Information

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT02930226     History of Changes
Other Study ID Numbers: S-14-12
IND 17154 ( Other Identifier: FDA )
Study First Received: October 6, 2016
Last Updated: October 7, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

ClinicalTrials.gov processed this record on May 25, 2017