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Ampligen on Immune, Cardiovascular Functioning

Discussion in 'Active Clinical Studies' started by Cort, Jun 15, 2009.

  1. Cort

    Cort Phoenix Rising Founder

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    Raleigh, NC
    Study of Ampligen in Chronic Fatigue Syndrome

    This study is currently recruiting participants.
    Verified by Hemispherx Biopharma, September 2005
    First Received: September 16, 2005 Last Updated: October 24, 2006 History of Changes
    Sponsored by: Hemispherx Biopharma
    Information provided by: Hemispherx Biopharma
    ClinicalTrials.gov Identifier: NCT00215813
    Purpose
    This is an open label study of Ampligen in patients with chronic fatigue syndrome.


    Condition Intervention Phase
    Chronic Fatigue Syndrome
    Drug: Ampligen (poly I: poly C12U)
    Phase III

    Study Type: Interventional
    Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Expanded Access Assignment, Safety/Efficacy Study
    Official Title: An Open Label Study of Ampligen in Chronic Fatigue Syndrome

    Resource links provided by NLM:

    MedlinePlus related topics: Chronic Fatigue Syndrome
    Drug Information available for: Ampligen
    U.S. FDA Resources

    Further study details as provided by Hemispherx Biopharma:

    Detailed Description:
    An Open-Label Study of Poly I: Poly C12U (Ampligen) in Patients with Severely Debilitating Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME). The FDA approved the study for cost recovery. Patients enrolled in the study are responsible for costs related to the therapy, e.g., drug cost, infusion cost, cost of supplies, diagnostic and other laboratory testing.

    Eligibility

    Ages Eligible for Study: 18 Years to 65 Years
    Genders Eligible for Study: Both
    Accepts Healthy Volunteers: No
    Criteria
    Inclusion Criteria:

    Diagnosis of myalgic encephalomyelitis (ME) as defined by the 1988 Centers for Disease Control and Prevention (CDC) case definition for chronic fatigue syndrome (CFS) ongoing for >= 12 months (other clinical conditions which could present with similar symptoms must be excluded).
    Age Range: >= 18 years old, <= 65 years old.
    Males or non-pregnant, non-lactating females: Females must be of non-child bearing potential (either post-menopausal for two years or surgically sterile including tubal ligation) or using an effective means of contraception (birth control pills, intrauterine device, diaphragm). Females who are less than two (2) years post-menopausal, those with tubal ligations and those using contraception must have a negative serum pregnancy test within the four (4) weeks prior to the first study medication infusion. Females of child bearing potential agree to use an effective means of contraception from four (4) weeks prior to the baseline pregnancy test until four (4) weeks after the last study medication infusion.
    A reduced quality of life as determined by a Karnofsky performance score (KPS) of >= 20 and <= 60. The KPS must be rounded in increments of ten (10).
    Ability to provide written informed consent indicating awareness of the investigational nature of this study.
    Documentation (during baseline or historically following onset of CFS/ME) of a negative antinuclear antibody test (ANA) or a negative anti-ds (double-stranded) DNA, a negative rheumatoid factor, and an erythrocyte sedimentation rate (ESR). Documentation during baseline of a normal T4 (or other laboratory evidence that subject is euthyroid) is also required.
    Contacts and Locations
    Please refer to this study by its ClinicalTrials.gov identifier: NCT00215813

    Contacts
    Contact: Sharon Conway 215-988-0080 sharon@hemispherx.net

    Show 51 Study Locations
    Sponsors and Collaborators
    Hemispherx Biopharma
    Investigators
    Principal Investigator: Daniel Peterson, M.D. Sierra Internal Medicine
    Principal Investigator: Lucinda Bateman, M.D. Fatigue Consultation Clinic
    Principal Investigator: Charles W. Lapp, M.D. Hunter-Hopkins Center, P.A.
    More Information
     

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