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

NCT ID: NCT01097590

Last Updated: 2013-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Ulcerative Colitis

Keywords

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ulcerative colitis leukapheresis treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active TLA Gut™ column

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

Group Type EXPERIMENTAL

Active TLA Gut™ column

Intervention Type DEVICE

Five consecutive treatment sessions. The therapy will be administrated every second day.

Placebo TLA Gut™column

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

Five consecutive treatment sessions. The placebo therapy will be administrated every second day.

Interventions

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Active TLA Gut™ column

Five consecutive treatment sessions. The therapy will be administrated every second day.

Intervention Type DEVICE

Placebo

Five consecutive treatment sessions. The placebo therapy will be administrated every second day.

Intervention Type DEVICE

Other Intervention Names

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TLA Gut™

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IBD Column Therapies International AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Eberhardson, Dr

Role: PRINCIPAL_INVESTIGATOR

Karolinska Universitetssjukhuset 171 76 Stockholm

Locations

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Södersjukhuset

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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461:2009/501

Identifier Type: OTHER

Identifier Source: secondary_id

TLA001

Identifier Type: -

Identifier Source: org_study_id