Last updated: 11/04/2018 00:12:57
Compassionate use for subcutaneous (SC) Belimumab
GSK study ID
207616
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer available
No longer available
Trial overview
Official title: Compassionate use for subcutaneous (SC) Belimumab
Trial description: GlaxoSmithKline (GSK) have submitted a Biologic License Application (BLA) for the subcutaneous formulation of belimumab which is currently under review by the Food and Drug Administration (FDA). The goal of this individual patient compassionate use supply is to provide a patient with subcutaneous belimumab for the period of 1 year or until the subcutaneous formulation of belimumab becomes approved for use by the FDA and is commercially available to this patient, whichever is sooner. You can access GSK’s Policy on Compassionate via http://www.gsk.com/media/3368/compassionate-use.pdf.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: SC belimumab 200 mg
Enrollment:
Not applicable
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
N/A to Invalid Date
Type
Expanded Access
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Not applicable
- 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).
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
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:
Trial location(s)
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53215
Status
Recruiting
Study documents
Not applicable
Results overview
Not applicable
Recruitment status
No longer available
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable
Additional information about the trial
Not applicable
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