HealthyPhase 2NCT00435968
Safety and Immune Enhancing Effects of Acute Dosing of COLD-fX in Healthy Adults
A Phase 2 study testing CVT E002 (Cold-fX) in people with Healthy, run by CV Technologies at 1 site in United States.
Trial summary
Subjects will be asked to participate in a four day research study of the immune system effects and safety of short-term acute dosing of Cold-fX. The purpose of the study is to determine the effects of acute dosing of Cold-fX for 3 days on the immune system compared to a placebo (dummy pill). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CVT E002 (Cold-fX)
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Jul 2007
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General good health
- Willing to adhere to the requirements of the protocol, including availability for follow-up visits
- Willing and able to sign written informed consent
Who cannot join
- Individuals with known HIV infection
- Individuals with malignancy
- Individuals with a history or symptoms of unstable cardiovascular disease
- Individuals with renal abnormalities
- Individuals having a history or symptoms of pulmonary disease
- Individuals having acute or active chronic liver disease
Show all 19Show fewer
- Individuals having neurologic or psychiatric disease
- Individuals having active tuberculosis
- Individuals having multiple sclerosis
- Individuals having bleeding disorders
- Individuals with planned surgery over the course of the trial or having had major surgery in the past 6 mo.
- Individuals with a history of alcohol/drug abuse
- Pregnant and lactating women
- Individuals on prescribed medication with the exception of oral contraceptives
- Individuals with Crohn's disease, Lupus, Rheumatoid arthritis, Colitis or any other auto-immune disease
- Individuals using natural health products or dietary supplements for 2 weeks prior and during the trial
- Individuals having allergies to ginseng or to any known component of the drug product or placebo
- Smokers (smoking > 10 cigarettes/day)
- Alcoholics (drinking > 10 drinks/week)
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Subjects will be asked to participate in a four day research study of the immune system effects and safety of short-term acute dosing of Cold-fX.
The purpose of the study is to determine the effects of acute dosing of Cold-fX for 3 days on the immune system compared to a placebo (dummy pill). Safety of the acute dosing will be determined through various blood tests carried out during the study.
Read the detailed description
Eligible volunteers from Hackensack University Medical Centre will be randomly assigned to either the treatment or placebo group with equal numbers in each group.
The treatment will consist of taking three capsules of CVT-E002 (600mg) or placebo three times daily on Day 1, two capsules of CVT-E002 (400mg) or placebo three times daily on Day 2 and one capsule of CVT-E002 (200mg) or placebo three times daily on Day 3.
A fasting blood sample will be collected on all 4 days of study participation. Immunological assays and blood chemisty safety tests will be performed on the samples. Serum samples will also be collected and stored until futher analysis for various cytokines.
Any adverse events experienced during this study will be documented.
- Conditions
- Healthy
- Being tested
- CVT E002 (Cold-fX)
- Keywords
- NK Cells, Cytokines, Lymphocytes, Immunoglobulins, Th1 response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVT E002 (Cold-fX)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in innate and Th1 immune responses of the subjects
Secondary outcomes (3)
Proportions of different leukocytes and lymphocytes in blood
Intracellular and plasma concentrations of various cytokines and immunoglobulins
Incidence and severity of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2007 (estimated)
- Study startMar 2007
- Study completionJul 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CV Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven Sperber, MD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435968
- Sponsor's protocol ID
- CVT-E002-2006-1
- Status last verified
- Jul 2007
- First submitted
- 14 Feb 2007
- Last updated
- 17 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immune Enhancing Effects of Acute Dosing of COLD-fX in Healthy Adults
- ClinicalTrials.gov ID
- NCT00435968
- Acronym / sponsor ID
- CVT-E002-2006-1
- Conditions
- Healthy
- Keywords
- NK Cells, Cytokines, Lymphocytes, Immunoglobulins, Th1 response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CV TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Study completion
- Jul 2007 (actual)
- First posted
- 16 Feb 2007 (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.
Subjects will be asked to participate in a four day research study of the immune system effects and safety of short-term acute dosing of Cold-fX.
The purpose of the study is to determine the effects of acute dosing of Cold-fX for 3 days on the immune system compared to a placebo (dummy pill). Safety of the acute dosing will be determined through various blood tests carried out during the study.
Detailed description
Eligible volunteers from Hackensack University Medical Centre will be randomly assigned to either the treatment or placebo group with equal numbers in each group.
The treatment will consist of taking three capsules of CVT-E002 (600mg) or placebo three times daily on Day 1, two capsules of CVT-E002 (400mg) or placebo three times daily on Day 2 and one capsule of CVT-E002 (200mg) or placebo three times daily on Day 3.
A fasting blood sample will be collected on all 4 days of study participation. Immunological assays and blood chemisty safety tests will be performed on the samples. Serum samples will also be collected and stored until futher analysis for various cytokines.
Any adverse events experienced during this study will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- General good health
- Willing to adhere to the requirements of the protocol, including availability for follow-up visits
- Willing and able to sign written informed consent
Key exclusion criteria (19 listed)
- Individuals with known HIV infection
- Individuals with malignancy
- Individuals with a history or symptoms of unstable cardiovascular disease
- Individuals with renal abnormalities
- Individuals having a history or symptoms of pulmonary disease
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 |
|---|---|---|
| CVT E002 (Cold-fX) | Drug | – |
Primary outcome
The change in innate and Th1 immune responses of the subjects
3 secondary outcomes
Proportions of different leukocytes and lymphocytes in blood
Intracellular and plasma concentrations of various cytokines and immunoglobulins
Incidence and severity of adverse events
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 17 Jul 2007.
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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.
Steven Sperber, MD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CVT E002 (Cold-fX) in people with Healthy, run by CV Technologies 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 3 inclusion and 19 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 17 Jul 2007. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The change in innate and Th1 immune responses of the subjects. 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 17 Jul 2007.