Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124514
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2005-07-26
Brief Title:
Triptorelin for Ovary Protection in Childhood Onset Lupus
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Triptorelin for Ovary Protection in Childhood Onset Lupus
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the safety of triptorelin when used for the protection of the ovaries pair of female reproductive organs during cyclophosphamide therapy for systemic lupus erythematosus SLE lupus and to see what effects good or bad it has on patients The study will be done with female patients who have been diagnosed with systemic lupus erythematosus are younger than 21 years of age and require intravenous cyclophosphamide to control the disease Each patient will be in the study for approximately 23 months until 4 months after the intravenous cyclophosphamide treatment has been completed
This study is currently being conducted at 3 sites across the United States and Brazil Los Angeles Cincinnati and San Paulo Brazil A total of 50 patients will participate in this study
Each patient will be randomized assigned to one of 5 groups Randomization means that patients are put into a group completely by chance It is like flipping a coin Neither the patient nor the study staff knows what group the patient is in The patient has a 20 chance of being placed in any group
This is a dose escalation study each patient will receive the first dose of the study drug T1 - T4 placebo If a patient has complete ovarian suppression on day 27 after the initial injection of study drug then she will remain on this weight-adjusted dose of study drug throughout the study The dose will be increased up for a weight gain of 5kg or greater The dose will not be adjusted downward for a weight loss If COS was not maintained with the 1st dose of study drug then the subsequently injected 2nd dose will be increased by 25 or at least 20 microgramkgdose The maximal dose of 150 microgramkgdose will not be exceeded The absolute maximum dose is 20 mg
Funding Source FDA OOPD and Watson Pharmaceuticals
This study is currently being conducted at 3 sites across the United States and Brazil Los Angeles Cincinnati and San Paulo Brazil A total of 50 patients will participate in this study
Each patient will be randomized assigned to one of 5 groups Randomization means that patients are put into a group completely by chance It is like flipping a coin Neither the patient nor the study staff knows what group the patient is in The patient has a 20 chance of being placed in any group
This is a dose escalation study each patient will receive the first dose of the study drug T1 - T4 placebo If a patient has complete ovarian suppression on day 27 after the initial injection of study drug then she will remain on this weight-adjusted dose of study drug throughout the study The dose will be increased up for a weight gain of 5kg or greater The dose will not be adjusted downward for a weight loss If COS was not maintained with the 1st dose of study drug then the subsequently injected 2nd dose will be increased by 25 or at least 20 microgramkgdose The maximal dose of 150 microgramkgdose will not be exceeded The absolute maximum dose is 20 mg
Funding Source FDA OOPD and Watson Pharmaceuticals
Detailed Description:
Lupus is an autoimmune disease that may harm all organs in the body and especially affects the kidney brain skin and lungs Cyclophosphamide is a very effective medication to treat lupus but it can damage the ovaries pair of reproductive organs
Only female lupus patients may participate in this study
Only female lupus patients may participate in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FD-R-00239 | OTHER_GRANT | FDA OOPD | None |