The Safety of Autologous Lyophilized Plasma Versus Fresh Frozen Plasma in Healthy Volunteers

NCT00968487 | Completed Phase 1

• 1 other identifier: 2009-I-LyP-1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

A single-site, single-blind study of ascending doses of Lyophilized Plasma in normal healthy volunteers.

Conditions

Healthy

Keywords

Lyophilized Plasma; Fresh Frozen Plasma; Hemorrhage; Coagulopathy; Autologous; HemCon; Plasmapheresis; Freeze Drying; Transfusion; Resuscitation; Safety of Lyophilized Plasma in Normal, Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of increasing doses of infused autologous units of LyP in normal healthy volunteers and to define possible LyP adverse reactions.

  1 day, 7 day, 14 day, and 28 day follow-ups after infusion.

Secondary Outcomes (1)

• To demonstrate that coagulation function assays and specific coagulation factors [Cohort 3 only] are similar within clinically meaningful levels, post-infusion of either autologous LyP or FFP.

  1 day, 7 day, 14 day, and 28 day follow up after second infusion.

Study Arms (2)

Lyophilized Plasma

EXPERIMENTAL

Biological: Lyophilized Plasma

Fresh Frozen Plasma

ACTIVE COMPARATOR

Other: Fresh Frozen Plasma

Interventions

Lyophilized Plasma BIOLOGICAL

Lyophilized Plasma is serves as a source of plasma proteins for subjects who are deficient in plasma proteins. The donor and recipient are the same person, therefore the process is autologous. HemCon's lyophilized plasma originates from FFP from screened individual donors to significantly reduce the risk of bloodborne disease transmission and undesired transfusion-associated reactions. Each single-donor unit is tested (per required of the blood supply) to reduce the risk of transmission of infectious agents and hence, maximize subject safety.

Lyophilized Plasma

Fresh Frozen Plasma OTHER

The fluid portion of one unit of human blood that has been centrifuged, separated, and frozen solid at -18 °C (-0.4 °F) (or colder) within 6 hours of collection.

Fresh Frozen Plasma

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-breast feeding females as they present interest
• Minimum weight, 140 pounds (64 kg) or 175 pounds for Cohort 3 only
• Ages 18-55 years
• Subject self-reports that he/she feels well and healthy
• Subject is able to donate one unit of whole blood based on the AABB donor history questionnaire with modifications indicated. Volunteers with history of travel which puts them at risk for vCJD will be eligible to participate.
• Has read the educational materials on donating blood and has had his/her questions answered
• Able and willing to provide informed consent
• Available for the duration of the trial (approximately 8 weeks for Cohorts 1 and 2 and 12 weeks for Cohort 3) 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. A highly effective method of birth control is 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 (IUDs), sexual abstinence or vasectomized partner.
• Female subjects must have a negative serum pregnancy test prior to enrollment.
• Understands the English language
• Scored greater or equal to 35 on the Duke Activity Status Index (DSAI)

You may not qualify if:

• Known liver, kidney, cardiovascular, neurologic, gastrointestinal, blood, endocrine/ metabolic, autoimmune or pulmonary disease; treated or untreated hypertension (see precise cut-off below)
• Cancer of any kind, under treatment or resolved
• Known or past coagulopathy conditions or blood disease
• Currently using medications for anticoagulant therapy
• Currently taking fish oil supplements
• Any conditions, medications, etc. on the AABB medical deferral list
• Previous use of clotting factor concentrate(s)
• Past diagnosis of stroke or transient ischemic attack
• Current or history of drug or alcohol abuse. Used needles to take drugs, steroids, or anything not prescribed by a doctor
• Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness or received a positive test result for HIV infection.
• Current or past infection with Hepatitis B or Hepatitis C virus
• Has received positive test for Syphilis
• Has received positive test for West Nile Virus
• Female subject who is pregnant, lactating or with a positive pregnancy test
• Currently taking an antibiotic or another medication for an infection.

Sponsors & Collaborators

• HemCon Medical Technologies, Inc: lead

Study Sites (1)

Hoxworth Blood Center

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Hemorrhage; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jose Cancelas, M.D., Ph.D.

  Hoxworth Blood Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 31, 2009
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 24, 2012

Record last verified: 2012-02

Locations

US (1)