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NCT01088243 · ClinicalTrials.gov registry record · Phase 1
Targeting Oxidative Stress in Chronic Beryllium Disease
A Phase 1 study, sponsored by National Jewish Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01088243: Completed Phase 1 study, sponsored by National Jewish Health.
NCT01088243 is a Phase 1 study that has completed, run by National Jewish Health. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01088243, a Phase 1 study, has completed, sponsored by National Jewish Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this study is to understand if a drug called mesalamine helps to control inflammation associated with chronic beryllium disease (CBD). We hypothesize that in CBD subjects treated with prednisone, mesalamine treatment will enhance the immunosuppressive effects of prednisone, and thus reduce the immune response to beryllium.
Primary Outcome
Primary endpoints are beryllium proliferation responses (BeLPT) in PBMCs (peripheral blood mononuclear cells) and BAL (bronchoalveolar lavage) cells. The BeLPT is a blood test that measures the immune response to beryllium exposure. If immune cells multiply in response to beryllium, this is considered an abnormal test results. If immune cells do not multiple, this is considered a normal test results. Results are reported as "stimulation index", which is a ratio of the number of cells grown with
Interventions
- DRUG Placebo
- DRUG Mesalamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2010-03 |
| Est. Completion | 2015-03 |
| Phase | Phase 1 |
What the finished NCT01088243 record still lists
NCT01088243 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01088243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01088243 about?
NCT01088243 is a clinical study titled "Targeting Oxidative Stress in Chronic Beryllium Disease". The purpose of this study is to understand if a drug called mesalamine helps to control inflammation associated with chronic beryllium disease (CBD). We hypothesize that in CBD subjects treated with prednisone, mesalamine treatment will enhance the immunosuppressive effects of prednisone, and thus r...
What is the current status of trial NCT01088243?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2010-03. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01088243?
The interventions under investigation include: Placebo (DRUG), Mesalamine (DRUG).
Who is sponsoring clinical trial NCT01088243?
This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01088243's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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