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Clinical Trials/NCT01217125
NCT01217125
Completed
Phase 4

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

Fundacio Puigvert0 sites18 target enrollmentOctober 2008
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ConditionsAngiomyolipoma
DrugsSirolimus

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Angiomyolipoma
Sponsor
Fundacio Puigvert
Enrollment
18
Primary Endpoint
Angiomyolipoma volume
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
May 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Fundacio Puigvert
Responsible Party
Principal Investigator
Principal Investigator

Roser Torra

MD, PhD

Fundacio Puigvert

Eligibility 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

Outcomes

Primary Outcomes

Angiomyolipoma volume

Time Frame: 2 years

Measured by MRI

Secondary Outcomes

  • skin lesions, AML complications,(2 years)

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