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Study of Ampligen in Chronic Fatigue Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Hemispherx Biopharma
Sponsor:
Information provided by (Responsible Party):
Hemispherx Biopharma
ClinicalTrials.gov Identifier:
NCT00215813
First received: September 16, 2005
Last updated: November 19, 2014
Last verified: November 2014

September 16, 2005
November 19, 2014
March 1997
February 2018   (final data collection date for primary outcome measure)
Safety [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
Evaluate safety
Not Provided
Complete list of historical versions of study NCT00215813 on ClinicalTrials.gov Archive Site
Quality of Life Assessments [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
Karnofsky Performance Score (KPS), Activities of Daily Living (ADL), SF-36 and SCL-90
Not Provided
Not Provided
Not Provided
 
Study of Ampligen in Chronic Fatigue Syndrome
An Open-Label Study Of Poly I:Poly C12U (AMPLIGEN®) in Patients With Severely Debilitating Chronic Fatigue Syndrome (CFS)

This is an open label study of Ampligen in patients with chronic fatigue syndrome.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Fatigue Syndrome
Drug: Poly I: Poly C12U
200-400 mg IV infusions given twice weekly over a period of 30-60 minutes
Other Names:
  • Ampligen
  • Rintatolimod
  • Experimental: Group 1
    CFS patients will receive 200-400 mg IV infusions of Poly I: Poly C12U given twice weekly over a period of 30-60 minutes
    Intervention: Drug: Poly I: Poly C12U
  • No Intervention: Group 2
    Healthy non-CFS patients will not receive study medication
  • No Intervention: Group 3
    CFS patients will not receive study medication
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
February 2018
February 2018   (final data collection date for primary outcome measure)

Group 1 Inclusion Criteria:

  1. Diagnosis of Chronic Fatigue Syndrome (>= 12 months) as defined by the 1988 Centers for Disease Control and Prevention CDC case definition for CFS or as defined only by the 1994 CDC case definition of CFS (Fukuda et al., Ann Intern Med. 1994; 121:953-959) (other clinical conditions which could present with similar symptoms must be excluded.).
  2. Age Range: >= 18 years old, <= 70 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). Alternatively, female patients with a male partner having a successful vasectomy (considered successful if a volunteer reports that a male partner has either documentation of azoospermia by microscopy or a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post-vasectomy).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 at baseline within the four (4) weeks prior to the first study medication infusion. Every four weeks, and at study termination a pregnancy test should be performed, either serum or urine stick test. However, if the urine result is positive, a serum pregnancy test will be performed. 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. All male patients agree not to be a sperm donor and to use an effective means of contraception while on study medication and until 90 days after the last study medication infusion.
  4. 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).
  5. Ability to provide written informed consent indicating awareness of the investigational nature of this study.
  6. Documentation (during baseline or historically following the onset of CFS) 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.

Group 1 Exclusion Criteria:

  1. Inability to return for scheduled treatment and assessments.
  2. Chronic or intercurrent acute medical disorder or disease making implementation or interpretation of the protocol or results difficult or unsafe.
  3. Pregnant or lactating females.
  4. Therapy with interferons, interleukins, or other cytokines or investigational drugs within 6 weeks of beginning study medication. Subjects must give written informed consent prior to discontinuation of investigational drugs.

Group 2 Inclusion Criteria:

1. Same as Group 1 Inclusion Criteria numbers 2, 3 and 5 listed above.

Group 2 Exclusion Criteria:

1. Same as all Group 1 Exclusion Criteria listed above.

Group 3 Inclusion Criteria:

1. Same as Group 1 Inclusion Criteria numbers 1, 2, 3, 4 and 5 listed above.

Group 3 Exclusion Criteria:

1. Same as all Group 1 Exclusion Criteria listed above.

Both
18 Years to 70 Years
Yes
Contact: Diane Young 732-249-3250 ext 609 diane.young@hemispherx.net
Contact: Ann Marie Coverly 215-988-0080 ext 115 annmarie.coverly@hemispherx.net
United States
 
NCT00215813
AMP 511
No
Hemispherx Biopharma
Hemispherx Biopharma
Not Provided
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.
Principal Investigator: Nancy Klimas, M.D. Nova Southeastern University Chronic Fatigue Center
Principal Investigator: Derek Enlander, MD Private Practice CFIDS Fibromyalgia & CFS
Hemispherx Biopharma
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP