Trial Information
CLINICAL TRIAL TO DETERMINE THE EFFICACY AND SAFETY OF RAPAMYCIN IN ANGIOMYOLIPOMAS IN PATIENTS WITH TUBEROUS SCLEROSIS
Inclusion Criteria:
Diagnosis of tuberousclerosis Angiomyolipoma >2cm age>10 years
Exclusion Criteria:
Creatinine >4 No recent AML bleeding No hepatic abnormalities (liver tests 2fold)
Hematocrit<27% Thrombocytopenia (<100.000/mm3) Leukopenia (<3000/mm3) Ischemic cardiopathy
Recent surgery (2 months prior to enrollment) Pregnancy Serum cholesterol over 7.8 mmol/l
or hypertriglyceridemia fasten(>4.6 mmol/l) non controlled with drugs malignancy in the
previous 2 years allergy to macrolides
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Angiomyolipoma volume
Outcome Description:
Measured by MRI
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Roser Torra, MD,PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fundacio Puigvert, Barcelona
Authority:
Spain: Spanish agency of medicine and health care products
Study ID:
EudraCT 2007-005978-30
NCT ID:
NCT01217125
Start Date:
October 2008
Completion Date:
May 2011
Related Keywords:
- Angiomyolipoma
- tuberousclerosis, angiomyolipoma, rapamycin
- Sclerosis
- Tuberous Sclerosis
- Angiomyolipoma