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NCT03189888 Clinical Trial

Granulocyte-monocyte Apheresis in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03189888
Other study ID # 5/2012
Secondary ID
Status Completed
Phase N/A
First received June 13, 2017
Last updated June 14, 2017
Start date January 2013
Est. completion date December 2013

Study information
Verified date June 2017
Source Valduce Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• apheresis

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Valduce Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary steroid-free clinical remission 3 months
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