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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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27 February 2024 |
Main ID: |
NCT04125472 |
Date of registration:
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10/10/2019 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1
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Scientific title:
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Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1 |
Date of first enrolment:
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January 28, 2020 |
Target sample size:
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Recruitment status: |
Approved for marketing |
URL:
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https://clinicaltrials.gov/ct2/show/NCT04125472 |
Study type:
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Expanded Access |
Study design:
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Phase:
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Countries of recruitment
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Belgium
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Canada
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France
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French Polynesia
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Germany
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Italy
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Netherlands
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Spain
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Medical Director |
Address:
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Telephone:
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Email:
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Affiliation:
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Alnylam Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Documented diagnosis of Primary Hyperoxaluria Type 1
Exclusion Criteria:
- Clinically significant health concerns (with the exception of PH1)
- Received an investigational agent within 30 days before the first dose of lumasiran or
are in follow-up of another clinical study
- Previously or currently participating in lumasiran clinical study
- History of liver transplant
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Primary Hyperoxaluria
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Intervention(s)
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Drug: Lumasiran
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Secondary ID(s)
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ALN-GO1-006
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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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