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NCT01266317 · ClinicalTrials.gov registry record · Phase 1
Combined PEX, Rituximab and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations
A Phase 1 study of IPF, sponsored by Michael Donahoe.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT01266317 is a Phase 1 study of IPF that has completed, run by Michael Donahoe. The registered enrollment target is 9 participants, below the 292-participant average among 3 other IPF trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01266317, a Phase 1 study of IPF, has completed, sponsored by Michael Donahoe.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label Phase I/II trial to assess the feasibility and safety of combined plasma exchange (PEX), rituximab, and conventional corticosteroid administration on the outcome of hospitalized patients with acute IPF exacerbations. The specific aims of this study are: 1. To assess the feasibility and safety of combined PEX, rituximab, and conventional corticosteroid administrations for the treatment of hospitalized patients with acute IPF exacerbations by monitoring indices of respiratory (PaO2) and cardiovascular function during the treatment interval. 2. To assess the efficacy of combined PEX, rituximab, and conventional corticosteroid administrations for the treatment of hospitalized patients with acute IPF exacerbations on patient survival in comparison to historical controls. Patient survival for this investigation will be defined using the composite outcome of 60 day survival and/or survival to lung transplantation. Subjects between 18 and 80 years of age who have a confirmed diagnosis of IPF, and meet all the study requirements will be enrolled in this study. A total of 10 subjects of both genders and all ethnic backgrounds with acute IPF exacerbations hospitalized at University of Pittsburgh Medical Center will be enrolled in this study.
Conditions Studied
Interventions
- DRUG Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids
Study Locations (1)
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-03 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01266317
The ClinicalTrials.gov registry entry for NCT01266317 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 292-participant average among 3 other IPF trials with a reported enrollment target (97% lower). The listed sponsor is Michael Donahoe, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with IPF appearing as the primary indexed condition, and to 1 intervention - of which Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids is the first listed.
NCT01266317 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01266317 about?
NCT01266317 is a clinical study titled "Combined PEX, Rituximab and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations". This is an open-label Phase I/II trial to assess the feasibility and safety of combined plasma exchange (PEX), rituximab, and conventional corticosteroid administration on the outcome of hospitalized patients with acute IPF exacerbations. The specific aims of this study are: 1. To assess the feasib...
What is the current status of trial NCT01266317?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2011-03. Estimated completion is 2015-07.
What conditions does trial NCT01266317 study?
This clinical trial studies the following conditions: IPF.
What interventions are being tested in trial NCT01266317?
The interventions under investigation include: Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids (DRUG).
Who is sponsoring clinical trial NCT01266317?
This trial is sponsored by Michael Donahoe, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01266317 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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