HealthyPhase 1NCT00968487
The Safety of Autologous Lyophilized Plasma Versus Fresh Frozen Plasma in Healthy Volunteers
A Phase 1 study testing Lyophilized Plasma and Fresh Frozen Plasma in people with Healthy, run by HemCon Medical Technologies, Inc at 1 site in United States.
Trial summary
A single-site, single-blind study of ascending doses of Lyophilized Plasma in normal healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lyophilized Plasma and Fresh Frozen Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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)
Who cannot join
- 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
Show all 32Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study of the Safety of Ascending Doses of Autologous Lyophilized Plasma Versus Fresh Frozen Plasma in Normal Healthy Volunteers
A single-site, single-blind study of ascending doses of Lyophilized Plasma in normal healthy volunteers.
Read the 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 incorporates plasmapheresis-derived autologous plasma (FFP) for infusion(s) to eliminate variables and events known to be related to allogenic transfusion. Subjects will be enrolled at a blood center and provide autologous FFP that will be shipped to the sponsor site and used as the starting material to manufacture LyP. Once manufacturing is complete, the LyP (autologous) will be returned to the blood center for reconstitution and infusion into subjects. Maximum dosage within this study will approach "massive transfusion" (1 liter in Cohort 3) to obtain a preliminary assessment of safety. One half of the FFP obtained from subjects in Cohort 3 (only) will be shipped to the sponsor and returned to the site (but not manufactured into LyP) to serve as the control (autologous FFP).
- Conditions
- Healthy
- Being tested
- Lyophilized Plasma, Fresh Frozen Plasma
- Keywords
- Lyophilized Plasma, Fresh Frozen Plasma, Hemorrhage, Coagulopathy, Autologous, HemCon, Plasmapheresis, Freeze Drying, Transfusion, Resuscitation, Safety of Lyophilized Plasma in Normal, Healthy Volunteers
- Medical subject headings
- Hemorrhage, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyophilized PlasmaBiological
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.
Fresh Frozen PlasmaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lyophilized Plasma | Experimental | Not described Receives: Biological: Lyophilized Plasma |
| Fresh Frozen Plasma | Active comparator | Not described Receives: Other: Fresh Frozen Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day, 7 day, 14 day, and 28 day follow up after second infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startJun 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- HemCon Medical Technologies, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Cancelas, M.D., Ph.D., Principal investigator, Hoxworth Blood Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968487
- Sponsor's protocol ID
- 2009-I-LyP-1
- Status last verified
- Feb 2012
- First submitted
- 26 Aug 2009
- Last updated
- 24 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the Safety of Ascending Doses of Autologous Lyophilized Plasma Versus Fresh Frozen Plasma in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00968487
- Acronym / sponsor ID
- 2009-I-LyP-1
- Conditions
- Healthy
- Keywords
- Lyophilized Plasma, Fresh Frozen Plasma, Hemorrhage, Coagulopathy, Autologous, HemCon, Plasmapheresis, Freeze Drying
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- HemCon Medical Technologies, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 31 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 incorporates plasmapheresis-derived autologous plasma (FFP) for infusion(s) to eliminate variables and events known to be related to allogenic transfusion. Subjects will be enrolled at a blood center and provide autologous FFP that will be shipped to the sponsor site and used as the starting material to manufacture LyP. Once manufacturing is complete, the LyP (autologous) will be returned to the blood center for reconstitution and infusion into subjects. Maximum dosage within this study will approach "massive transfusion" (1 liter in Cohort 3) to obtain a preliminary assessment of safety. One half of the FFP obtained from subjects in Cohort 3 (only) will be shipped to the sponsor and returned to the site (but not manufactured into LyP) to serve as the control (autologous FFP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lyophilized Plasma | Experimental | Biological: Lyophilized Plasma |
| Fresh Frozen Plasma | Active comparator | Other: Fresh Frozen Plasma |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lyophilized PlasmaLyophilized 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. | Biological | Lyophilized Plasma |
| Fresh Frozen PlasmaThe 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. | Other | Fresh Frozen Plasma |
Primary outcome
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.
Time frame: 1 day, 7 day, 14 day, and 28 day follow-ups after infusion.
1 secondary outcome
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.
Time frame: 1 day, 7 day, 14 day, and 28 day follow up after second infusion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2012.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Cancelas, M.D., Ph.D. principal investigator
Hoxworth Blood Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lyophilized Plasma and Fresh Frozen Plasma in people with Healthy, run by HemCon Medical Technologies, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 day, 7 day, 14 day, and 28 day follow-ups after infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2012.