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Oral Administration of AlequelTM for Patients With Inflammatory Bowel Disease (IBD)

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Alequel
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Crohn's disease

Exclusion Criteria:

  • Immune suppression

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    AlequelTM

    Arm Description

    AlequelTM

    Outcomes

    Primary Outcome Measures

    Number of Participants With Improved in Disease Activity

    Secondary Outcome Measures

    Full Information

    First Posted
    April 28, 2014
    Last Updated
    September 21, 2014
    Sponsor
    Hadassah Medical Organization
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02185183
    Brief Title
    Oral Administration of AlequelTM for Patients With Inflammatory Bowel Disease (IBD)
    Official Title
    Phase 2 Clinical Trial for Oral Administration of Alequel for Patients With IBD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    January 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hadassah Medical Organization

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Oral administration of Alequel, a mixture of proteins derived from the patient's bowel will be tested in patients with inflammatory bowel disease.
    Detailed Description
    Oral administration of Alequel prepared from patients biopsies will be tested in patients with inflammatory bowel disease to determine its anti inflammatory effect.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crohn's Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    N/A
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AlequelTM
    Arm Type
    Experimental
    Arm Description
    AlequelTM
    Intervention Type
    Drug
    Intervention Name(s)
    Alequel
    Intervention Description
    Alequel
    Primary Outcome Measure Information:
    Title
    Number of Participants With Improved in Disease Activity
    Time Frame
    15 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Crohn's disease Exclusion Criteria: Immune suppression
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yaron Ilan, M.D.
    Organizational Affiliation
    Hadassah Medical Organization
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Oral Administration of AlequelTM for Patients With Inflammatory Bowel Disease (IBD)

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