Ascending Doses of Autologous FDP vs FFP

NCT02930226 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: S-14-12IND 17154
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Assess the safety of single infusions with RePlas FDP product at increasing fixed doses

Conditions

Freeze Dried Plasma in Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  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

  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.

Study Arms (6)

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Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD

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Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD

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Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD

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Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD

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

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

Biological: Autologous Freeze Dried Plasma (FDP); Biological: Fresh Frozen Plasma (FFP)

Interventions

Autologous Freeze Dried Plasma (FDP) BIOLOGICAL

Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers

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) BIOLOGICAL

Controlled FFP in cohort 3 only

Reinfusion 3 units FDP, 3 units FFP (1st); Reinfusion 3 units FDP, 3 units FFP (2nd)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead

Study Sites (1)

Hoxworth Blood Center

Cincinnati, Ohio, 45267, United States

Location

Results Point of Contact

• Title: Jose A. Cancelas, M.D., Ph.D.
• Organization: University of Cincinnati

Jose.Cancelas@cchmc.org

513-558-1324

Study Officials

• Jose A Cancelas, MD, PhD

  Hoxworth Blood Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 12, 2016
• Study Start: February 13, 2017
• Primary Completion: August 2, 2018
• Study Completion: August 2, 2018
• Last Updated: February 12, 2021
• Results First Posted: April 24, 2020

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)