Clinical trial NCT00037128: Study of GL701 in Men With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
SLE
DHEA
GL701
Lead sponsor: Genelabs Technologies
Sponsor class: INDUSTRY
First posted: 2002-05-17
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Lupus flares and other symptoms associated with systemic lupus erythematosus (SLE) may be caused by a deficiency of dehydroepiandrosterone (DHEA). GL701 is an investigational new drug meant to enhance DHEA levels. This study is designed to evaluate both the safety and efficacy of GL701 in male lupus patients.


Eligibility criteria: Inclusion Criteria

* Patient must have a diagnosis of SLE \> 6 months according to the 1989 revised ACR criteria. Patient must meet at least four of the eleven ACR criteria for systemic lupus
* Patient must have a modified SLEDAI score \> 3 at both screening and qualifying visits (Appendix A-2)
* Patient must be treated for SLE with doses of prednisone \< 30 mg/day (including those on NO glucocorticoid therapy) unchanged for \> 6 weeks prior to study entry (including both screening and qualifying visits). Prednisone dose in patient's receiving alternate day therapy will be the mean daily prednisone dose
* Patient treated with azathioprine, methotrexate, or hydrochloroquine must be on a stable dose with no change in dose for at least 6 weeks preceding the study
* Patient must be able to read and speak English and willing to sign an informed consent in English

Exclusion Criteria

* Patient with a history of prostate cancer
* Patient with elevated Prostate Specific Antigen (PSA)
* Patient diagnosed with liver disease, defined as AST or ALT \> 3x the upper limit of normal
* Patient ingesting body building/anabolic steroids within the last 6 months preceding the study
* Patient with end stage renal disease or receiving hemodialysis treatment
* Patient with serum creatinine \> 2 mg/dl or creatinine clearance \< 60 ml/min
* Patient receiving treatment with ACTH within the 3 months preceding study entry
* Patient receiving androgens, immunoglobulins, cyclophosphamide, cyclosporin A, or other immunosuppressive agents, except azathioprine, methotrexate, and hydrochloroquine within the last 3 months
* Patient with known hypersensitivity to DHEA or the inactive ingredients used in the GL70l formulation (cornstarch, lactose, and magnesium stearate)
* Patient who participated in any prior DHEA study or administration of DHEA within the past 3 months
* Patient using any investigational agents within the longer of 30 days or 10 half-lives of the agent
* Patient with any condition which in the Investigator's or sponsor's opinion is sufficient to prevent adequate compliance with the study or likely to confuse follow-up evaluation (e.g.. alcoholism, drug addiction, acute withdrawal from chemical dependency, psychiatric disease)
* Patient requires treatment/medication prohibited by protocol
* Patient with any serious EKG abnormality as determined by the Investigator

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Genelabs Technologies, Inc.
state: California
Study officials:
References: