Granulocyte-monocyte Apheresis in Ulcerative Colitis

June 14, 2017 updated by: Arnaldo Amato, Valduce Hospital

Granulocyte-monocyte Apheresis in Steroid-dependent, Azathioprine-intolerant/Resistant Moderate Ulcerative Colitis: a Prospective Multicentre Study

BACKGROUND: Granulocyte-monocyte apheresis has been proposed for the treatment of ulcerative colitis, although is limited by costs and variability of results.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • moderate UC with steroid-dependence and azathioprine intolerance or resistance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: apheresis
leukapheresis in ulcerative colitis
Device: apheresis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
steroid-free clinical remission
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valduce Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2013

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

June 13, 2017

First Submitted That Met QC Criteria

June 14, 2017

First Posted (ACTUAL)

June 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 14, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5/2012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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