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NCT03286556 · ClinicalTrials.gov registry record · Phase 2
Autoantibody Reduction for Acute Exacerbations of Idiopathic Pulmonary Fibrosis
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
NCT03286556 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 82 participants.
The verdict
NCT03286556, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
Study Summary
Acute exacerbations (AE) are a dreaded manifestation of idiopathic pulmonary fibrosis (IPF) that presents with rapidly worsening respiratory function over days to weeks. AE account for about 1/2 the deaths in IPF patients, and are refractory to all medical therapies attempted to date. Considerable preliminary data shows pathological B-cell abnormalities and autoantibodies are present in AE-IPF and associated with disease severity. The experimental therapy here (therapeutic plasma exchange plus rituximab plus intravenous immunoglobulin) is mechanistically targeted to ameliorate autoantibody-mediated pulmonary injury. Anecdotal pilot studies indicate these treatments have significant benefit for a disease syndrome that has, until now, been almost invariably inexorable. This clinical trial has the potential to profoundly affect current paradigms and treatment approaches to patients with AE-IPF.
Interventions
- DRUG Treatment as Usual (TAU)
- DRUG Autoantibody Reductive Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2018-09-04 |
| Est. Completion | 2024-08-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03286556
The ClinicalTrials.gov registry entry for NCT03286556 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Treatment as Usual (TAU) is the first listed.
NCT03286556 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03286556 about?
NCT03286556 is a clinical study titled "Autoantibody Reduction for Acute Exacerbations of Idiopathic Pulmonary Fibrosis". Acute exacerbations (AE) are a dreaded manifestation of idiopathic pulmonary fibrosis (IPF) that presents with rapidly worsening respiratory function over days to weeks. AE account for about 1/2 the deaths in IPF patients, and are refractory to all medical therapies attempted to date. Considerable ...
What is the current status of trial NCT03286556?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2018-09-04. Estimated completion is 2024-08-01.
What interventions are being tested in trial NCT03286556?
The interventions under investigation include: Treatment as Usual (TAU) (DRUG), Autoantibody Reductive Therapy (DRUG).
Who is sponsoring clinical trial NCT03286556?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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