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

NCT01097590 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2013-08-21

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Active TLA Gut™ column

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

DEVICE

Placebo

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

Sponsors & Collaborators

  • IBD Column Therapies International AB

    lead INDUSTRY

Principal Investigators

  • Michael Eberhardson, Dr · Karolinska Universitetssjukhuset 171 76 Stockholm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-10-31
Completion
2011-11-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01097590 on ClinicalTrials.gov