Ampligen in Chronic Fatigue Syndrome
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00215813 |
|
Expanded Access Status :
Available
First Posted : September 22, 2005
Last Update Posted : April 12, 2024
|
Sponsor:
AIM ImmunoTech Inc.
Information provided by (Responsible Party):
AIM ImmunoTech Inc.
- Study Details
- Tabular View
- Disclaimer
- How to Read a Study Record
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | September 16, 2005 | ||||||||
| First Posted Date | September 22, 2005 | ||||||||
| Last Update Posted Date | April 12, 2024 | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Ampligen in Chronic Fatigue Syndrome | ||||||||
| Brief Summary | This is an open label study of Ampligen in patients with chronic fatigue syndrome. | ||||||||
| 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. | ||||||||
| Study Type | Expanded Access | ||||||||
| Expanded Access Type | Intermediate-size Population, Treatment IND/Protocol | ||||||||
| Intervention | Drug: Poly I: Poly C12U (Rintatolimod)
200-400 mg IV infusions given twice weekly over a period of 30-60 minutes
Other Names:
|
||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Expanded Access Status | Available | ||||||||
| Contacts |
|
||||||||
| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT00215813 | ||||||||
| Current Responsible Party | AIM ImmunoTech Inc. | ||||||||
| Original Responsible Party | Not Provided | ||||||||
| Current Study Sponsor | AIM ImmunoTech Inc. | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
|
||||||||
| PRS Account | AIM ImmunoTech Inc. | ||||||||
| Verification Date | April 2024 | ||||||||