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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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10 April 2023 |
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Main ID: |
NCT04034485 |
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Date of registration:
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22/07/2019 |
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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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Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH
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Scientific title:
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Randomized, Open-Label, Cross-Over, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy |
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Date of first enrolment:
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December 7, 2019 |
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Target sample size:
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65 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT04034485 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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India
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Israel
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Norway
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South Africa
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Turkey
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United States
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Contacts
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Name:
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Evan A Stein, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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LIB Therapeutics |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- HoFH diagnosed clinically and confirmed by genotyping
- Weight of >30 kg and body mass index (BMI) >17 and <40 kg/m2
- stable diet and lipid-lowering oral therapies for at least 4 weeks
Exclusion Criteria:
- mipomersen within 6 months of screening;
- LDL or plasma apheresis <2 months prior to randomization
- history of non-response to PCSK9 mAb or presence of receptor negative/null LDLR
activity expected to result in non-response to PCSK9 inhibition
- prior or active clinical condition or acute and/or unstable systemic disease
compromising subject inclusion
Age minimum:
10 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Homozygous Familial Hypercholesterolemia
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Intervention(s)
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Drug: evolocumab
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Drug: lerodalcibep
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Primary Outcome(s)
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Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 24
[Time Frame: baseline to 24 weeks on each treatment]
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Secondary Outcome(s)
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The incidence and severity of treatment emergent adverse events (TEAEs)
[Time Frame: baseline to 24 weeks on each treatment]
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Secondary ID(s)
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LIB003-003
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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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