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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: Completed Phase 1 study of Ulcerative Colitis, sponsored by Avaxia Biologics, Incorporated.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessments weekly during treatment and 1 week post treatment
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
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2013-02 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT01759056 record still lists
NCT01759056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower).
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 lists 16 locations in 12 states (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.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01759056's enrollment target sits among peer trials
33 100th of 122 higher than 23 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis 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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