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NCT02315898 · ClinicalTrials.gov registry record · Phase 2
Inhaled Tissue Plasminogen Activator for Acute Plastic Bronchitis
A Phase 2 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT02315898: Completed Phase 2 study, sponsored by University of Michigan.
NCT02315898 is a Phase 2 study that has completed, run by University of Michigan. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02315898, a Phase 2 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
Plastic bronchitis (PB) is a rare, most often pediatric disease characterized by the formation of obstructive airway casts primarily composed of fibrin. There is presently no FDA-approved pharmacotherapy for PB, but acute exacerbations of the illness are often treated with inhaled tissue plasminogen activator (tPA). To date, this is done somewhat anecdotally because there has been no safety or efficacy testing of this treatment. In addition, there is presently no reliable surrogate marker of adverse drug events. Nevertheless, in the absence of inhaled tPA treatment, PB-induced respiratory distress can be severe, often warranting urgent or emergent bronchoscopy for cast removal, or can sometimes result in respiratory failure. As such there is a significant unmet need for safety and efficacy testing of inhaled tPA and for biomarkers of drug response. Objectives and Endpoints: The objectives of this protocol are to: 1) test the safety and efficacy of an inhaled tPA regimen in children with PB; and 2) identify potential candidate biomarkers of inhaled tPA drug response. Safety endpoints will consist of the development of new, active bleeding that is systemic and/or pulmonary and/or new hematuria (defined as gross hematuria). Secondary endpoints of efficacy will also be measured (e.g., frequency of cast production). Urine and blood will also be collected for the development of potential biomarkers of inhaled tPA drug response. Funding source- FDA OOPD
Primary Outcome
The number of subjects with new systemic and/or pulmonary and/or gross hematuria
Interventions
- DRUG Treatment-inhaled tPA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-03-19 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 2 |
What the finished NCT02315898 record still lists
NCT02315898 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Treatment-inhaled tPA is the first listed.
NCT02315898 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02315898 about?
NCT02315898 is a clinical study titled "Inhaled Tissue Plasminogen Activator for Acute Plastic Bronchitis". Plastic bronchitis (PB) is a rare, most often pediatric disease characterized by the formation of obstructive airway casts primarily composed of fibrin. There is presently no FDA-approved pharmacotherapy for PB, but acute exacerbations of the illness are often treated with inhaled tissue plasminogen...
What is the current status of trial NCT02315898?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2018-03-19. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT02315898?
The interventions under investigation include: Treatment-inhaled tPA (DRUG).
Who is sponsoring clinical trial NCT02315898?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02315898's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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