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| Sponsor: | National Center for Research Resources (NCRR) |
|---|---|
| Collaborator: |
Northwestern University |
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004665 |
Purpose
OBJECTIVES:
I. Evaluate the long-term safety and tolerance of a synthetic formulation of dehydroepiandrosterone, GL701, in patients with systemic lupus erythematosus who have completed a prior GL701 protocol.
| Condition | Intervention | Phase |
|---|---|---|
|
Systemic Lupus Erythematosus |
Drug: dehydroepiandrosterone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Systemic lupus erythematosus by American College of Rheumatology criteria Mild to moderate disease characterized as follows: Prednisone dose (or equivalent) 10 to 30 mg/day No daily dose 1 mg/kg or greater No alternate-day regimen Failed prednisone taper in last 12 months and dose stable for at least 6 weeks prior to entry OR No attempt to taper in last 12 months and dose stable for at least 3 months prior to entry Prior completion of dehydroepiandrosterone (DHEA) study required No prior participation in double-blind DHEA study at Stanford University --Prior/Concurrent Therapy-- No concurrent immunosuppressants No concurrent participation in other clinical studies No investigational agents within the longer of 30 days or 10 half-lives of the agent At least 3 months since immunosuppressants, including: Adrenocorticotropin hormone Androgens Cyclophosphamide Azathioprine Intravenous immune globulin At least 1 month since change in dose of nonsteroidal anti-inflammatory drugs or hydroxychloroquine --Patient Characteristics-- Age: 18 and over Sex: Female only Performance status: Not specified Other: No hypersensitivity to DHEA or inactive ingredient in GL701 formulation, i.e., cornstarch, lactose, or magnesium stearate No condition that would prevent adequate compliance with study No history of breast cancer or reproductive tract malignancy Negative pregnancy test required within 2 weeks prior to entry Reliable contraception required of fertile women No estrogen-containing oral contraceptive
Contacts and Locations
More Information
| Study ID Numbers: | 199/11935, NU-552 |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004665 History of Changes |
| Health Authority: | United States: Federal Government |
|
arthritis & connective tissue diseases immunologic disorders and infectious disorders rare disease systemic lupus erythematosus |
|
Autoimmune Diseases Immunologic Factors Immune System Diseases Lupus Erythematosus, Systemic Physiological Effects of Drugs |
Adjuvants, Immunologic Connective Tissue Diseases Dehydroepiandrosterone Pharmacologic Actions |