|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
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 |
Inclusion Criteria:
Contacts and Locations| Contact: Sharon Conway | 215-988-0080 | sharon@hemispherx.net |
Show 51 Study Locations| 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
| Study ID Numbers: | AMP 511 |
| Study First Received: | September 16, 2005 |
| Last Updated: | October 24, 2006 |
| ClinicalTrials.gov Identifier: | NCT00215813 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Chronic Fatigue Syndrome CFS ME Ampligen poly I:poly C12U |
|
Fatigue Immunologic Factors Interferons Central Nervous System Diseases Encephalomyelitis Fatigue Syndrome, Chronic Antiviral Agents Ampligen |
Virus Diseases Signs and Symptoms Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Myalgic Encephalomyelitis Poly I-C |
|
Interferon Inducers Anti-Infective Agents Fatigue Disease Immunologic Factors Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Encephalomyelitis Fatigue Syndrome, Chronic Antiviral Agents |
Pharmacologic Actions Ampligen Virus Diseases Signs and Symptoms Muscular Diseases Pathologic Processes Musculoskeletal Diseases Neuromuscular Diseases Therapeutic Uses Syndrome Poly I-C |