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NCT03878069 · ClinicalTrials.gov registry record
Registry Study of Revcovi Treatment in Patients With ADA-SCID
A clinical trial, sponsored by Chiesi Farmaceutici S.p.A..
- Completed
- Registry status
- 32
- Enrollment target
NCT03878069: Completed study, sponsored by Chiesi Farmaceutici S.p.A..
NCT03878069 is a clinical trial that has completed, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03878069 has completed, sponsored by Chiesi Farmaceutici S.p.A..
- COMPLETED
- Registry status
- 32 participants
- Enrollment target
Study Summary
This registry study is being conducted in patients with adenosine deaminase severe combined immune deficiency (ADA-SCID) who require enzyme replacement therapy (ERT) treatment with Revcovi. Data on safety and on measures of efficacy are collected.
Primary Outcome
A deficiency in the ADA enzyme results in a build-up of dAXP nucleotides, which are toxic to lymphocytes and lead to impairment of immune function. A detoxified level of dAXP concentration is defined as a trough value of 0.02 millimoles per liter (mmol/L) or lower. Data are presented as the number of subjects who met the targeted threshold at the final measurement, whether that took place at Month 24 or earlier.
Interventions
- BIOLOGICAL elapegademase-lvlr
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2023-01-18 |
What the finished NCT03878069 record still lists
NCT03878069 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 32 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which elapegademase-lvlr is the first listed.
NCT03878069 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03878069 about?
NCT03878069 is a clinical study titled "Registry Study of Revcovi Treatment in Patients With ADA-SCID". This registry study is being conducted in patients with adenosine deaminase severe combined immune deficiency (ADA-SCID) who require enzyme replacement therapy (ERT) treatment with Revcovi. Data on safety and on measures of efficacy are collected.
What is the current status of trial NCT03878069?
This trial is currently completed. The enrollment target is 32 participants. The study started on 2019-09-30. Estimated completion is 2023-01-18.
What interventions are being tested in trial NCT03878069?
The interventions under investigation include: elapegademase-lvlr (BIOLOGICAL).
Who is sponsoring clinical trial NCT03878069?
This trial is sponsored by Chiesi Farmaceutici S.p.A., which has 30 total clinical trials registered on ClinicalTrials.gov.
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