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NCT04387110 · ClinicalTrials.gov registry record
Ocrelizumab in Breastmilk
A clinical trial, sponsored by University of California, San Francisco.
- Completed
- Registry status
- 30
- Enrollment target
NCT04387110: Completed study, sponsored by University of California, San Francisco.
NCT04387110 is a clinical trial that has completed, run by University of California, San Francisco. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04387110 has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study Summary
The goal of the current project is to measure the levels of ocrelizumab in the breastmilk of women with multiple sclerosis (MS) and clinically isolated syndrome (CIS) who are postpartum, and to collect information on 12-month infant development outcomes (length, weight, head circumference, infections) in their offspring. This study will fill a significant unmet need as many women with MS at high risk for postpartum relapses are not effectively treated for their MS in the postpartum period due to lack of information about the presence, concentration and effects of medications in breastmilk.
Primary Outcome
Levels of ocrelizumab (μg/mL) in the breastmilk of women at the selected timepoints before and after infusion (hour 8, hour 24, day 7, day 20, day 30, day 60, and day 90). If receiving two infusions the samples will be as follows: pre-infusion, hour 8, hour 24, day 7, and day 14 after infusion 1(prior to infusion 2); then post infusion 2, at hour 8, hour 24, day 7, day 20, day 30, day 60, and day 90. This outcome will be measured by breastmilk concentration (μg/mL), average breastmilk concentrat
Interventions
- DRUG Ocrelizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-08-07 |
| Est. Completion | 2022-03-01 |
What the finished NCT04387110 record still lists
NCT04387110 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Ocrelizumab is the first listed.
NCT04387110 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04387110 about?
NCT04387110 is a clinical study titled "Ocrelizumab in Breastmilk". The goal of the current project is to measure the levels of ocrelizumab in the breastmilk of women with multiple sclerosis (MS) and clinically isolated syndrome (CIS) who are postpartum, and to collect information on 12-month infant development outcomes (length, weight, head circumference, infection...
What is the current status of trial NCT04387110?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2020-08-07. Estimated completion is 2022-03-01.
What interventions are being tested in trial NCT04387110?
The interventions under investigation include: Ocrelizumab (DRUG).
Who is sponsoring clinical trial NCT04387110?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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