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Calling for Patients: An Open Label Study of Ampligen in Chronic Fatigue Syndrome

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www.ProHealth.com • March 15, 2006


This study is currently recruiting patients. Verified by Hemispherx Biopharma September 2005
Sponsored by: Hemispherx Biopharma
Information provided by: Hemispherx Biopharma
ClinicalTrials.gov Identifier: NCT00215813 Purpose:
An Open Label Study of Ampligen in Chronic Fatigue Syndrome Condition:Chronic Fatigue Syndrome/ME
Intervention Drug: Ampligen (poly I: poly C12U)
Phase III MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Expanded Access Assignment, Safety/Efficacy Study Further study details as provided by Hemispherx Biopharma: 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 - 65 Years; Genders Eligible for Study: Both Inclusion Criteria: 1. Diagnosis of Myalgic Encephalomyelitis (ME) as defined by the 1988 CDC case definition for Chronic Fatigue Syndrome (CFS) ongoing for ³ 12 months (other clinical conditions which could present with similar symptoms must be excluded). 2. Age Range: ³ 18 years old, £ 65 years old. 3. 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. 4. A reduced quality of life as determined by a Karnofsky Performance Score (KPS) of ³ 20 and £ 60. The KPS must be rounded in increments of ten (10). 5. Ability to provide written informed consent indicating awareness of the investigational nature of this study. 6. Documentation (during baseline or historically following onset of CFS/ME) of a negative 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. Exclusion Criteria: Location and Contact Information Please refer to this study by ClinicalTrials.gov identifier NCT00215813 Sharon Conway 215-988-0080 sharon@hemispherx.net Study chairs or principal investigators Daniel Peterson, M.D., Principal Investigator, Sierra Internal Medicine Lucinda Bateman, M.D., Principal Investigator, Fatigue Consultation Clinic Charles W. Lapp, M.D., Principal Investigator, Hunter-Hopkins Center, P.A. More Information Study ID Numbers: AMP 511 Last Updated: December 8, 2005
Record first received: September 16, 2005
ClinicalTrials.gov Identifier: NCT00215813
Health Authority: United States: Food and Drug Administration



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