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A Study to Evaluate a Leukapheresis Treatment in Patients With Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Active TLA Gut™ column
Placebo
Sponsored by
IBD Column Therapies International AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring ulcerative colitis, leukapheresis treatment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of active, moderate-to-severe, Ulcerative Colitis.

Exclusion criteria;

  • Local intestinal treatments with suppositories, enemas or clysmas during the last 4 weeks
  • Current daily smoking habits
  • Other severe diseases as detailed in the protocol
  • History of hypersensitivity to heparin

Sites / Locations

  • Södersjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active TLA Gut™ column

Placebo TLA Gut™column

Arm Description

The active column contain an engineered protein with the ability to specifically bind the inflammatory cells.

The placebo column is identical to the active column except it does not contain the engineered protein that specifically bind the inflammatory cells.

Outcomes

Primary Outcome Measures

Expression level of MHC class II on antigen presenting cells.
The primary outcome will be assessed by flow cytometry.

Secondary Outcome Measures

The number of cells and/or expression level of gut homing and activation markers on lymphocytes and monocytes. Safety and tolerability. Clinical effect on signs and symptoms of the disease.
The immunological analysis will be peformed by flow cytometry. The safety will be measured by recording adverese events at each visit. The disease activity will be assessed by using the Mayo Score Questionnaire.

Full Information

First Posted
March 25, 2010
Last Updated
August 20, 2013
Sponsor
IBD Column Therapies International AB
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1. Study Identification

Unique Protocol Identification Number
NCT01097590
Brief Title
A Study to Evaluate a Leukapheresis Treatment in Patients With Ulcerative Colitis
Official Title
A Randomized Placebo Controlled, Single Centre Study to Evaluate a Novel Leukapheresis Treatment in Patients With Ulcerative Colitis.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IBD Column Therapies International AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether a treatment of a novel leukapheresis column is safe and effective in patients with moderate to severe ulcerative colitis.
Detailed Description
Ulcerative colitis (UC) is a chronic and relapsing disease and is characterized by superficial inflammation in the colonic epithelium. The inflammation is maintained by continuous supply of inflammatory cells from the circulating blood to the intestinal mucosa. Existing therapy e.g. corticosteroids and immunosuppressants are inadequate with an overall long-term remission rate of only 50-60%. Those treatments are also associated with severe side effects why there is a need of new therapies. The aim of this study is to investigate a novel leukapheresis treatment with the potential to reduce the number of inflammatory cells homing to the gut mucosa. By drawing blood from the patient and pass it through the investigational column the inflammatory cells are removed. The blood, depleted of the inflammatory cells, is returned to the patient. The treatment thus enable down-regulation of the inflammation and consequently the inflammation can heal. The treatment is called Tailored leukapheresis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
ulcerative colitis, leukapheresis treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active TLA Gut™ column
Arm Type
Experimental
Arm Description
The active column contain an engineered protein with the ability to specifically bind the inflammatory cells.
Arm Title
Placebo TLA Gut™column
Arm Type
Placebo Comparator
Arm Description
The placebo column is identical to the active column except it does not contain the engineered protein that specifically bind the inflammatory cells.
Intervention Type
Device
Intervention Name(s)
Active TLA Gut™ column
Other Intervention Name(s)
TLA Gut™
Intervention Description
Five consecutive treatment sessions. The therapy will be administrated every second day.
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Five consecutive treatment sessions. The placebo therapy will be administrated every second day.
Primary Outcome Measure Information:
Title
Expression level of MHC class II on antigen presenting cells.
Description
The primary outcome will be assessed by flow cytometry.
Time Frame
change from baseline at day 5, 12, 28, 42 and 98.
Secondary Outcome Measure Information:
Title
The number of cells and/or expression level of gut homing and activation markers on lymphocytes and monocytes. Safety and tolerability. Clinical effect on signs and symptoms of the disease.
Description
The immunological analysis will be peformed by flow cytometry. The safety will be measured by recording adverese events at each visit. The disease activity will be assessed by using the Mayo Score Questionnaire.
Time Frame
change from baseline at day 5, 12,28, 42, 98.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of active, moderate-to-severe, Ulcerative Colitis. Exclusion criteria; Local intestinal treatments with suppositories, enemas or clysmas during the last 4 weeks Current daily smoking habits Other severe diseases as detailed in the protocol History of hypersensitivity to heparin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Eberhardson, Dr
Organizational Affiliation
Karolinska Universitetssjukhuset 171 76 Stockholm
Official's Role
Principal Investigator
Facility Information:
Facility Name
Södersjukhuset
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

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A Study to Evaluate a Leukapheresis Treatment in Patients With Ulcerative Colitis

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