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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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12 December 2020 |
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Main ID: |
NCT03125486 |
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Date of registration:
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18/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Compassionate Use for Subcutaneous (SC) Belimumab
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Scientific title:
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Compassionate Use for Subcutaneous (SC) Belimumab |
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Date of first enrolment:
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April 7, 2017 |
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Target sample size:
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Recruitment status: |
No longer available |
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URL:
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https://clinicaltrials.gov/show/NCT03125486 |
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Study type:
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Expanded Access |
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Study design:
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Phase:
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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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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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This is a protocol to support an emergency IND for compassionate use in one patient
requiring use of belimumab subcutaneous for SLE treatment (lacks venous access and cannot
receive IV belimumab).
Eligibility criteria is based on the following, as provided within GSK's policy on
compassionate use:
- The illness being treated is life threatening or seriously debilitating.
- There are no satisfactory alternative treatments (confirmed by the HCP).
- There is sufficient evidence to believe the benefit to the patient justifies the risk
You can access GSK's Policy on Compassionate via
http://www.gsk.com/media/3368/compassionate-use.pdf.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: SC belimumab 200 mg
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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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