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Granulocyte-monocyte Apheresis in Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
apheresis
Sponsored by
Valduce Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    apheresis

    Arm Description

    leukapheresis in ulcerative colitis

    Outcomes

    Primary Outcome Measures

    steroid-free clinical remission

    Secondary Outcome Measures

    Full Information

    First Posted
    June 13, 2017
    Last Updated
    June 14, 2017
    Sponsor
    Valduce Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03189888
    Brief Title
    Granulocyte-monocyte Apheresis in Ulcerative Colitis
    Official Title
    Granulocyte-monocyte Apheresis in Steroid-dependent, Azathioprine-intolerant/Resistant Moderate Ulcerative Colitis: a Prospective Multicentre Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (Actual)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Valduce Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    apheresis
    Arm Type
    Other
    Arm Description
    leukapheresis in ulcerative colitis
    Intervention Type
    Device
    Intervention Name(s)
    apheresis
    Primary Outcome Measure Information:
    Title
    steroid-free clinical remission
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: moderate UC with steroid-dependence and azathioprine intolerance or resistance

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29403531
    Citation
    Imperiali G, Amato A, Terpin MM, Beverina I, Bortoli A, Devani M, Vigano C; Study Group on IBD (GSMII). Granulocyte-Monocyte Apheresis in Steroid-Dependent, Azathioprine-Intolerant/Resistant Moderate Ulcerative Colitis: A Prospective Multicenter Study. Gastroenterol Res Pract. 2017;2017:9728324. doi: 10.1155/2017/9728324. Epub 2017 Dec 21.
    Results Reference
    derived

    Learn more about this trial

    Granulocyte-monocyte Apheresis in Ulcerative Colitis

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