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NCT00262132 · ClinicalTrials.gov registry record · Phase 3
Mycophenolate for Pulmonary Sarcoidosis
A Phase 3 study, sponsored by Medical University of South Carolina.
- Terminated
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
NCT00262132: Clinical Trial Phase 3 study, sponsored by Medical University of South Carolina.
NCT00262132 is a Phase 3 study that was terminated before completion, run by Medical University of South Carolina. The registered enrollment target is 20 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00262132, a Phase 3 study, was terminated before completion, sponsored by Medical University of South Carolina.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
Study Summary
Corticosteroids are presently the drug of choice for the treatment of pulmonary sarcoidosis. However, corticosteroids are associated with many significant side effects. For this reason, it would be beneficial to find an alternative agent to corticosteroids for the treatment of pulmonary sarcoidosis. This study is an open label trial of mycophenolate for new onset pulmonary sarcoidosis. Patients are candidates for this study if they have biopsy proven pulmonary sarcoidosis and a vital capacity or FEV1 less than 80% of predicted. Patients must undergo bronchoscopy where not only is the diagnosis of pulmonary sarcoidosis required, but in addition, cells are obtained from bronchoalveolar lavage. If the patients are diagnosed with pulmonary sarcoidosis, they are placed on an initial dose of 500mg BID of mycophenolate for 1 week. If their blood counts are not affected on this dose and they have no significant symptoms that are thought to be drug related, then their dose is escalated to 1g BID for the remaining 9 weeks of the study (the total study drug therapy time is 10 weeks). The patients are followed with multiple study visits. At these visits blood tests are drawn to make sure that there are no significant side effects from mycophenolate. In addition, the patients have a history and physical performed to evaluate the clinical state of their sarcoidosis and to detect mycophenolate side effects. On completion of 10 weeks of mycophenolate therapy, the patients undergo a second bronchoscopy with bronchoalveolar lavage to obtain cells for analysis. The patients are evaluated with spirometry, measurements of shortness of breath (dyspnea), and a quality of life scale (SF36) at serial visits during their study. The primary endpoint of the study is improved, unchanged or worse FVC. It is hoped that this pilot study will suggest that mycophenolate is a reasonable treatment option for new onset pulmonary sarcoidosis.
Interventions
- DRUG Mycophenolate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2003-09 |
| Est. Completion | 2006-08 |
| Phase | Phase 3 |
Why NCT00262132 stopped before completion
NCT00262132 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Mycophenolate is the first listed.
NCT00262132 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00262132 about?
NCT00262132 is a clinical study titled "Mycophenolate for Pulmonary Sarcoidosis". Corticosteroids are presently the drug of choice for the treatment of pulmonary sarcoidosis. However, corticosteroids are associated with many significant side effects. For this reason, it would be beneficial to find an alternative agent to corticosteroids for the treatment of pulmonary sarcoidosis....
What is the current status of trial NCT00262132?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2003-09. Estimated completion is 2006-08.
What interventions are being tested in trial NCT00262132?
The interventions under investigation include: Mycophenolate (DRUG).
Who is sponsoring clinical trial NCT00262132?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00262132's enrollment target sits among peer trials
20 1956th of 2000 higher than 32 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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