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NCT01759056 · ClinicalTrials.gov registry record · Phase 1

Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative Colitis

A Phase 1 study of Ulcerative Colitis, sponsored by Avaxia Biologics, Incorporated.

Completed
Registry status
Phase 1
Development phase
33
Enrollment target
16
Study locations

NCT01759056 is a Phase 1 study of Ulcerative Colitis that has completed, run by Avaxia Biologics, Incorporated. The registered enrollment target is 33 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower). The trial reports 16 study locations across 12 states.

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The verdict

NCT01759056, a Phase 1 study of Ulcerative Colitis, has completed, sponsored by Avaxia Biologics, Incorporated.

COMPLETED
Registry status
Phase 1
Development phase
33 participants
Enrollment target
16
Study locations

Study Summary

The purpose of this study is to evaluate the safety and tolerability as well as the pharmacodynamic effects of multiple doses of AVX-470 administered orally in patients with active ulcerative colitis.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG AVX 470

Study Locations (16)

Other

  • Gastro-Enterologie - Ghent
  • Gastro-enterologie - Leuven
  • Semmelweis Egyetem - Budapest
  • Debreceni Egyetem Orvos- és Egészségtudományi Centrum - Debrecen
  • Kenézy Kórház Rendelöintézet Egészségügyi Szolgáltató Kft. - Debrecen

California

  • Anaheim Clinical Trials - Anaheim

Colorado

  • Rocky Mountain Gastroenterology Associates - Lakewood

Florida

  • Shafran Gastroenterology Center - Winter Park

Maryland

  • Chevy Chase Clinical Research - Chevy Chase

Michigan

  • Clinical Research Institute of Michigan - Chesterfield

Missouri

  • Center for Digestive and Liver Disease - Mexico

Ohio

  • Remington-Davis, Inc. - Columbus

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2013-02
Est. Completion 2013-12
Phase Phase 1

Sponsor

Avaxia Biologics, Incorporated

1 total trials

What the Registry Record Tells You About NCT01759056

The ClinicalTrials.gov registry entry for NCT01759056 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower). The listed sponsor is Avaxia Biologics, Incorporated, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01759056 reports 16 study locations spanning 12 distinct geographic areas - top geographies include Other, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT01759056 about?

NCT01759056 is a clinical study titled "Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative Colitis". The purpose of this study is to evaluate the safety and tolerability as well as the pharmacodynamic effects of multiple doses of AVX-470 administered orally in patients with active ulcerative colitis.

What is the current status of trial NCT01759056?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2013-02. Estimated completion is 2013-12.

What conditions does trial NCT01759056 study?

This clinical trial studies the following conditions: Ulcerative Colitis.

What interventions are being tested in trial NCT01759056?

The interventions under investigation include: Placebo (DRUG), AVX 470 (DRUG).

Who is sponsoring clinical trial NCT01759056?

This trial is sponsored by Avaxia Biologics, Incorporated, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01759056 being conducted?

This trial has 16 study locations across California, Colorado, Florida, Maryland, Michigan. 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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