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OpenTrials
Completed

NCT Number: NCT01217125

Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis

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

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Key information

Conditions

Angiomyolipoma Neoplasms Neoplasms by Histologic Type Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue Perivascular Epithelioid Cell Neoplasms

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sirolimus

Drug

plasma levels between 4 and 8

Other names: Rapamune

Primary outcomes

  1. Angiomyolipoma volume

    Time frame: 2 years

    Measured by MRI

Secondary outcomes

  1. skin lesions, AML complications,

    Time frame: 2 years

    Evaluate skin lesions Collect event realted to AML

Sponsors and collaborators

Lead sponsor

Fundacio Puigvert

Other

Collaborators

  • Ministry of Health, Spain

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 8, 2010
Registry last updated
Mar 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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