Status:
COMPLETED
The Safety of Autologous Lyophilized Plasma Versus Fresh Frozen Plasma in Healthy Volunteers
Lead Sponsor:
HemCon Medical Technologies, Inc
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
A single-site, single-blind study of ascending doses of Lyophilized Plasma in normal healthy volunteers.
Detailed Description
This "first-in-human" Phase I, single-center, dose escalation study (using 3 dose levels) is proposed to assess the safety of infusing reconstituted lyophilized human plasma (LyP). The study design in...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
- Treatment or use of aspirin (or other platelet inhibiting agents) within 14 days of study donation and infusion visits
- In the past week, has had a headache and fever at the same time.
- Known intolerance to citric acid.
- Receipt of blood or blood products within the past 12 months
- Systolic blood pressure greater than 180 mmHg
- Diastolic blood pressure greater than 90 mmHg
- Temperature greater than 100° F
- Hematocrit will not be less than 38% for both male and female donors
- History of current mental or psychiatric condition
- Treatment with any investigational agent within one month before treatment application for 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 Investigator, make the subject unsuitable for enrollment
- Subject is institutionalized because of legal or regulatory order
- Other criteria based upon the AABB universal donor history questionnaire with the exception of travel to a vCJD area (i.e. travel to a vCJD area is not a study exclusion).
- Has had any vaccinations or injections in the past 8 weeks.
- Is a Medicare recipient
- Is uninsured (does not have health care insurance)
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00968487
Start Date
June 1 2010
End Date
December 1 2011
Last Update
February 24 2012
Active Locations (1)
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1
Hoxworth Blood Center
Cincinnati, Ohio, United States, 45267