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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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28 October 2024 |
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Main ID: |
NCT05252585 |
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Date of registration:
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16/02/2022 |
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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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A Phase IV Study of Safety and Efficacy of Everolimus in Taiwanese Patients With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma (TSC-AML)
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Scientific title:
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Phase IV, Prospective Single Arm Study of Safety and Efficacy of Votubia (Everolimus) in Taiwanese Adults With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma |
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Date of first enrolment:
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May 1, 2023 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT05252585 |
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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 4
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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+41613241111 |
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Email:
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novartis.email@novartis.com |
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Affiliation:
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Adult male or female patients from = 18 years of age.
2. Signed informed consent must be obtained prior to participation in the study.
3. Participants with TSC associated with renal AML which is eligible for treatment with
everolimus per local reimbursement criteria.
Exclusion Criteria:
1. Patients with severe hepatic impairment (Child-Pugh class C)
2. Any severe and/or uncontrolled medical conditions.
3. Pregnant or breast-feeding females.
4. Patients with hypersensitivity to the active substance, to other rapamycin
derivatives, or to any of the excipients.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Renal Angiomyolipoma
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Intervention(s)
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Drug: Everolimus
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Primary Outcome(s)
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Percentage of participants with adverse events (AEs), Serious AEs (SAEs) and AEs of special interest (AESI)
[Time Frame: From first dose of study treatment up to 56 weeks]
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Secondary Outcome(s)
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Angiomyolipoma (AML) response rate
[Time Frame: Up to 52 weeks]
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AML progression rate
[Time Frame: Up to 52 weeks]
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Percentage of participants with laboratory abnormalities
[Time Frame: From screening up to 56 weeks]
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Secondary ID(s)
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CRAD001M2402
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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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