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NCT01971814 · ClinicalTrials.gov registry record · Phase 1
Early Serum Infliximab Levels in Severe Ulcerative Colitis.
A Phase 1 study of Inflammatory Bowel Disease and Ulcerative Colitis (UC), sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT01971814: Completed Phase 1 study of Inflammatory Bowel Disease and Ulcerative Colitis (UC), sponsored by University of California, San Francisco.
NCT01971814 is a Phase 1 study of Inflammatory Bowel Disease and Ulcerative Colitis (UC) that has completed, run by University of California, San Francisco. The registered enrollment target is 11 participants, below the 403-participant average among 28 other Inflammatory Bowel Disease trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01971814, a Phase 1 study of Inflammatory Bowel Disease and Ulcerative Colitis (UC), has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of this study is to a.) evaluate whether early serum infliximab levels are predictive of avoidance of colectomy, b) evaluate whether serum albumin levels correlate with serum infliximab levels, and c) evaluate whether serum tumor necrosis factor levels are inversely correlated with serum infliximab levels. In patients hospitalized for severe ulcerative colitis and treated with high-dose infliximab, we predict that early serum infliximab levels (24, 48, and 72 hour) will be positively associated with clinical response and avoidance of colectomy.
Conditions Studied
Interventions
- DRUG Infliximab
Study Locations (1)
California
- University of California at San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
What the finished NCT01971814 record still lists
NCT01971814 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 403-participant average among 28 other Inflammatory Bowel Disease trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Inflammatory Bowel Disease appearing as the primary indexed condition, and to 1 intervention - of which Infliximab is the first listed.
NCT01971814 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01971814 about?
NCT01971814 is a clinical study titled "Early Serum Infliximab Levels in Severe Ulcerative Colitis.". The aim of this study is to a.) evaluate whether early serum infliximab levels are predictive of avoidance of colectomy, b) evaluate whether serum albumin levels correlate with serum infliximab levels, and c) evaluate whether serum tumor necrosis factor levels are inversely correlated with serum inf...
What is the current status of trial NCT01971814?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2013-11. Estimated completion is 2015-01.
What conditions does trial NCT01971814 study?
This clinical trial studies the following conditions: Inflammatory Bowel Disease, Ulcerative Colitis (UC).
What interventions are being tested in trial NCT01971814?
The interventions under investigation include: Infliximab (DRUG).
Who is sponsoring clinical trial NCT01971814?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01971814 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01971814's enrollment target sits among peer trials
11 28th of 28 higher than 1 of 28 other Inflammatory Bowel Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inflammatory Bowel Disease 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.
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