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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01217125
Date of registration: 06/10/2010
Prospective Registration: No
Primary sponsor: Fundacio Puigvert
Public title: Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis
Scientific title: CLINICAL TRIAL TO DETERMINE THE EFFICACY AND SAFETY OF RAPAMYCIN IN ANGIOMYOLIPOMAS IN PATIENTS WITH TUBEROUS SCLEROSIS
Date of first enrolment: October 2008
Target sample size: 18
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01217125
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Contacts
Name:     Roser Torra, MD,PhD
Address: 
Telephone:
Email:
Affiliation:  Fundacio Puigvert, Barcelona
Key inclusion & exclusion criteria

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



Age minimum: 10 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Angiomyolipoma
Intervention(s)
Drug: Sirolimus
Primary Outcome(s)
Angiomyolipoma volume [Time Frame: 2 years]
Secondary Outcome(s)
skin lesions, AML complications, [Time Frame: 2 years]
Secondary ID(s)
EudraCT 2007-005978-30
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ministry of Health, Spain
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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