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Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis

Primary Purpose

Angiomyolipoma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sirolimus
Sponsored by
Fundacio Puigvert
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angiomyolipoma focused on measuring tuberousclerosis, angiomyolipoma, rapamycin

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Angiomyolipoma volume
    Measured by MRI

    Secondary Outcome Measures

    skin lesions, AML complications,
    Evaluate skin lesions Collect event realted to AML

    Full Information

    First Posted
    October 6, 2010
    Last Updated
    March 7, 2012
    Sponsor
    Fundacio Puigvert
    Collaborators
    Ministry of Health, Spain
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01217125
    Brief Title
    Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis
    Official Title
    CLINICAL TRIAL TO DETERMINE THE EFFICACY AND SAFETY OF RAPAMYCIN IN ANGIOMYOLIPOMAS IN PATIENTS WITH TUBEROUS SCLEROSIS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2008 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    May 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fundacio Puigvert
    Collaborators
    Ministry of Health, Spain

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Angiomyolipoma
    Keywords
    tuberousclerosis, angiomyolipoma, rapamycin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Sirolimus
    Other Intervention Name(s)
    Rapamune
    Intervention Description
    plasma levels between 4 and 8
    Primary Outcome Measure Information:
    Title
    Angiomyolipoma volume
    Description
    Measured by MRI
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    skin lesions, AML complications,
    Description
    Evaluate skin lesions Collect event realted to AML
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Roser Torra, MD,PhD
    Organizational Affiliation
    Fundacio Puigvert, Barcelona
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23140536
    Citation
    Cabrera-Lopez C, Marti T, Catala V, Torres F, Mateu S, Ballarin J, Torra R. Assessing the effectiveness of rapamycin on angiomyolipoma in tuberous sclerosis: a two years trial. Orphanet J Rare Dis. 2012 Nov 11;7:87. doi: 10.1186/1750-1172-7-87.
    Results Reference
    derived

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    Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis

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