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Ascending Doses of Autologous FDP vs FFP

NCT02930226 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-02-12

Study results available
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Summary

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

Conditions

  • Freeze Dried Plasma in Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Jose A Cancelas, MD, PhD · Hoxworth Blood Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-13
Primary Completion
2018-08-02
Completion
2018-08-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02930226 on ClinicalTrials.gov