Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis

Angiomyolipoma Clinical Trial

Official title:

CLINICAL TRIAL TO DETERMINE THE EFFICACY AND SAFETY OF RAPAMYCIN IN ANGIOMYOLIPOMAS IN PATIENTS WITH TUBEROUS SCLEROSIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217125
• Other study ID #: EudraCT 2007-005978-30
• Status: Completed
• Phase: Phase 4
• First received: October 6, 2010
• Last updated: March 7, 2012
• Start date: October 2008
• Est. completion date: May 2011

Study information

• Verified date: March 2012
• Source: Fundacio Puigvert
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish agency of medicine and health care products
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether rapamycin is safe and effective in the treatment of renal angiomyolipomas in patients with tuberousclerosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angiomyolipoma
• Tuberous Sclerosis

Intervention

Drug:
• Sirolimus
plasma levels between 4 and 8

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fundacio Puigvert	Ministry of Health, Spain

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiomyolipoma volume	Measured by MRI	2 years	No
Secondary	skin lesions, AML complications,	Evaluate skin lesions Collect event realted to AML	2 years	No