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NCT01969409 · ClinicalTrials.gov registry record · Phase 2
Autoantibody Reduction Therapy in Patients With Idiopathic Pulmonary Fibrosis
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
NCT01969409 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 58 participants.
The verdict
NCT01969409, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
Study Summary
Recent research studies have suggested that proteins called antibodies that are produced by the immune system might be involved in the lung damage of idiopathic pulmonary fibrosis (IPF). Antibodies produced by the immune system normal help to fight infections by attacking bacteria and viruses without harming our own tissues. In patients with IPF, there is evidence that certain antibodies (called autoantibodies) attack the lung and contributes to the injury and scarring that occurs in IPF. Our recent studies have found that many IPF patients appear to have excessive autoantibody levels in blood and lungs that might make their disease worse. Rituximab is a medication approved by the Food and Drug Administration (FDA) for the treatment of autoantibody diseases such as rheumatoid arthritis. Rituximab works by destroying B cells, a type of white blood cell, called a B-lymphocyte, which produce autoantibodies. In this research study, rituximab will be given into a vein to reduce the autoantibody levels that we believe might be contributing to the lung damage in IPF. This study is being conducted to determine if rituximab provides beneficial effects for IPF patients by decreasing further lung injury.
Interventions
- DRUG Placebo
- DRUG Rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2014-01 |
| Est. Completion | 2020-11-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01969409
The ClinicalTrials.gov registry entry for NCT01969409 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 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 Placebo is the first listed.
NCT01969409 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01969409 about?
NCT01969409 is a clinical study titled "Autoantibody Reduction Therapy in Patients With Idiopathic Pulmonary Fibrosis". Recent research studies have suggested that proteins called antibodies that are produced by the immune system might be involved in the lung damage of idiopathic pulmonary fibrosis (IPF). Antibodies produced by the immune system normal help to fight infections by attacking bacteria and viruses withou...
What is the current status of trial NCT01969409?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2014-01. Estimated completion is 2020-11-30.
What interventions are being tested in trial NCT01969409?
The interventions under investigation include: Placebo (DRUG), Rituximab (DRUG).
Who is sponsoring clinical trial NCT01969409?
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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