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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 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.

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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.

Interventions

  • DRUG Infliximab

Study Locations (1)

California

  • University of California at San Francisco - San Francisco

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2013-11
Est. Completion 2015-01
Phase Phase 1

What the Registry Record Tells You About NCT01971814

The ClinicalTrials.gov registry entry for NCT01971814 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 403-participant average among 28 other Inflammatory Bowel Disease trials with a reported enrollment target (97% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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