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NCT01950507 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Budesonide and How It Interacts With Antifungal Drugs in People With Gastrointestinal Graft-Versus-Host Disease
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01950507: Clinical Trial Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT01950507 is a Phase 1 study that was terminated before completion, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01950507, a Phase 1 study, was terminated before completion, sponsored by National Institutes of Health Clinical Center (CC).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
Background: The gastrointestinal (GI) tract is commonly affected by acute graft-versus-host disease (aGVHD) and chronic GVHD (cGVHD) in patients who have undergone blood or marrow stem cell transplantation (BMT). Initially, patients are treated with systemic corticosteroids, which produce complete response rates in 35 percent. Although short courses of steroids are preferred to minimize adverse effects, many patients require systemic treatment chronically since GI GVHD can negatively impact quality of life and nutrition status. One option to minimize systemic steroid exposure is by nonabsorbable corticosteroids that act locally on the GI tract. Budesonide (Entocort EC, AstraZeneca, Wilmington, DE) is an FDA-approved oral topical corticosteroid for the treatment of mild to moderate active Crohn s disease involving the ileum and/or the ascending colon, and for maintenance of clinical remission of mild to moderate Crohn s disease involving the ileum and/or the ascending colon for up to 3 months. It has a high ratio of topical-to-systemic activity with minimally active metabolites, and undergoes extensive first-pass metabolism. Since both intestinal GVHD and Crohn s disease seem to share a similar pathogenic background, budesonide has been used in the BMT setting for GI GVHD, usually in combination with systemic corticosteroids (e.g. methylprednisolone) to improve clinical response and allow for more rapid tapering of systemic corticosteroid doses. First-pass metabolism is mediated mostly by the cytochrome P450 (CYP450) enzyme system. The liver is the major site of CYP450-mediated metabolism but the enterocytes of the intestinal epithelium are also an important site for drug metabolism. Budesonide undergoes significant metabolism by CYP enzymes with substantial first-pass metabolism. The potential for greater systemic availability of orally administered budesonide exists when it is given concurrently with triazole antifungals, which are commonly prescribed for prophy
Primary Outcome
To detect a 2-fold difference in the budesonide Cmax before and after azole administration between study day 7 and day 14 for each cohort.
Interventions
- DRUG Fluconazole
- DRUG Budesonide
- DRUG Micafungin
- DRUG Voriconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-02-20 |
| Est. Completion | 2020-02-26 |
| Phase | Phase 1 |
Why NCT01950507 stopped before completion
NCT01950507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 4 interventions - of which Fluconazole is the first listed.
NCT01950507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01950507 about?
NCT01950507 is a clinical study titled "Evaluation of Budesonide and How It Interacts With Antifungal Drugs in People With Gastrointestinal Graft-Versus-Host Disease". Background: The gastrointestinal (GI) tract is commonly affected by acute graft-versus-host disease (aGVHD) and chronic GVHD (cGVHD) in patients who have undergone blood or marrow stem cell transplantation (BMT). Initially, patients are treated with systemic corticosteroids, which produce complete ...
What is the current status of trial NCT01950507?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2014-02-20. Estimated completion is 2020-02-26.
What interventions are being tested in trial NCT01950507?
The interventions under investigation include: Fluconazole (DRUG), Budesonide (DRUG), Micafungin (DRUG), Voriconazole (DRUG).
Who is sponsoring clinical trial NCT01950507?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01950507's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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