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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have a diagnosis of SLE > 6 months according to the 1989 revised ACR criteria and meet at least four of the eleven ACR criteria for systemic lupus
Patient must be treated for SLE with doses of prednisone < 30 mg/day unchanged for > 6 weeks prior to study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing whether a new drug, GL701, is safe and effective in treating lupus symptoms in men. The drug is designed to increase levels of a hormone, DHEA, which may be deficient in people with lupus.
Who is the study for?
This trial is for men with systemic lupus erythematosus (SLE) diagnosed over 6 months ago, who have moderate disease activity and are on stable SLE medication doses. They must not be taking certain steroids or immunosuppressives recently, have no severe kidney or liver issues, no history of prostate cancer, and cannot be using any investigational drugs within the past month.Check my eligibility
What is being tested?
The study tests GL701's safety and effectiveness in raising DHEA levels to manage lupus symptoms. Participants will receive GL701 to see if it reduces lupus flares and improves overall health compared to their current treatment regimen without this drug.See study design
What are the potential side effects?
Potential side effects of GL701 may include reactions similar to those seen with hormone therapies since DHEA is a hormone precursor. These could range from oily skin and acne to changes in mood or energy levels; however, specific side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with lupus for over 6 months and meet at least four lupus criteria.
Select...
I have been on a stable dose of prednisone under 30 mg/day for my SLE for more than 6 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
Genelabs TechnologiesLead Sponsor
3 Previous Clinical Trials
269 Total Patients Enrolled
1 Trials studying Lupus
155 Patients Enrolled for Lupus
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with lupus for over 6 months and meet at least four lupus criteria.My liver tests are more than three times the normal limit.I have end-stage kidney disease or am on dialysis.My kidney function is reduced with creatinine levels above 2 mg/dl or clearance below 60 ml/min.I have been treated with ACTH in the last 3 months.I haven't taken certain immune-suppressing drugs, except for azathioprine, methotrexate, or hydrochloroquine, in the last 3 months.I have not been in a DHEA study or taken DHEA in the last 3 months.I need to take medication that is not allowed in this study.I have been on a stable dose of prednisone under 30 mg/day for my SLE for more than 6 weeks.I have been on a stable dose of azathioprine, methotrexate, or hydrochloroquine for at least 6 weeks.I have a history of prostate cancer.I have not taken bodybuilding steroids in the last 6 months.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the preferred qualities of participants in this research study?
"To be eligible for this trial, patients must have a diagnosis of libman-sacks disease and be between 18 and 0 years old. Around 40 people will be enrolled in the study."
Answered by AI
If a patient is over the age of 55, can they still enroll in this trial?
"This trial is only for patients that are aged 18 to 0. There are 17 other clinical trials that patients under 18 can enroll in and 107 trials for patients over the age of 65."
Answered by AI
Is this particular medication allowed by the FDA?
"We believe that this Phase 3 trial treatment is safe (scoring a 3 on our 1-to-3 scale) because there is both efficacy and safety data supporting it."
Answered by AI
If a patient were to want to enroll in this clinical trial, would they be able to do so at this time?
"No, this particular clinical trial is not currently recruiting patients. That being said, there are 124 other trials that are accepting participants. This trial was initially posted on 3/1/1998 and was last edited on 6/23/2005."
Answered by AI
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