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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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31 October 2022 |
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Main ID: |
NCT03253913 |
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Date of registration:
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10/08/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial
RESULT |
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Scientific title:
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Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial (RESULT) |
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Date of first enrolment:
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March 31, 2018 |
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Target sample size:
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25 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03253913 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Nishant Gupta, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Cincinnati |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Subjects enrolled in the trial must meet all of the following criteria.
1. Definitive diagnosis LAM based on the presence of characteristic cystic change on
high-resolution computed tomography (HRCT) of the chest. The diagnosis must be
confirmed by one of the following:
A) Histopathological confirmation by biopsy (lung, abdominal mass, lymph node or
kidney or cytology from thoracic or abdominal sources revealing human melanoma
black-45 (HMB45)+ staining of spindled/epithelioid cells) B) Compatible chest CT scan
findings in the setting of tuberous sclerosis, angiomyolipomas (diagnosed by CT,
magnetic resonance imaging (MRI) by the site radiologist or biopsy) or chylous pleural
effusion (verified by tap) C) Chest CT scan findings compatible with LAM and a VEGF-D
level = 800pg/ml.
2. Age 18 years or greater.
3. Signed and dated informed consent
4. Currently on sirolimus for treatment of LAM for at least 20 weeks
5. Evidence of disease stabilization on sirolimus as demonstrated by two stable values of
serum VEGF-D post initiation of sirolimus drawn at least 12 weeks apart from each
other. For the purpose of this study, a variation in serum VEGF-D of less than or
equal to 15% is considered stable.
Exclusion Criteria:
- Subjects who meet any of the following criteria are not eligible for enrollment as
study participants:
1. Known allergy or hypersensitivity to Resveratrol
2. Inability to provide informed consent
3. Active enrollment in other clinical drug trials for LAM
4. Pregnant or plan to become pregnant in the next 6 months
5. Breast feeding
6. Inability to comply with pulmonary function tests or follow up visits
7. Inadequate contraception
8. Use of estrogen containing medications within the 30 days prior to randomization
9. History of organ transplant
10. Actively listed for lung transplantation
11. Inability to comply with study procedures or attend scheduled study visits
12. Any clinically significant medical disease (other than LAM) that is associated
with an expected survival of less than 2 years, or likely to impact the ability
of the patient to participate in the study in the opinion of the investigator, or
impact the study efficacy or safety assessments.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Lymphangioleiomyomatosis
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Intervention(s)
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Drug: Resveratrol
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Drug: Sirolimus
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Primary Outcome(s)
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Change in serum VEGF-D level after treatment with a combination of resveratrol and sirolimus
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Difference in the San Diego Shortness of Breath Score (SD-SOB) quality of life assessment scores before and after treatment
[Time Frame: 24 weeks]
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Difference in the A Tool to Assess Quality of Life in LAM (ATAQ-LAM) quality of life assessment scores before and after treatment
[Time Frame: 24 weeks]
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Incidence of Treatment-Emergent Adverse Events
[Time Frame: 24 weeks]
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Rate of change in Pulmonary function tests (PFTs) before and after treatment
[Time Frame: 24 weeks]
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Difference in the EuroQOL visual analogue scale (EQ-5D) before and after treatment.
[Time Frame: 24 weeks]
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Difference in the St. George's Respiratory Questionnaire (SGRQ) quality of life assessment scores before and after treatment
[Time Frame: 24 weeks]
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Secondary ID(s)
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2016-4904
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1R34HL138235-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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