A Study to Evaluate a Leukapheresis Treatment in Patients With Ulcerative Colitis
A Randomized Placebo Controlled, Single Centre Study to Evaluate a Novel Leukapheresis Treatment in Patients With Ulcerative Colitis.
2 other identifiers
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 25, 2010
CompletedFirst Posted
Study publicly available on registry
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedAugust 21, 2013
March 1, 2010
1.6 years
March 25, 2010
August 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Expression level of MHC class II on antigen presenting cells.
The primary outcome will be assessed by flow cytometry.
change from baseline at day 5, 12, 28, 42 and 98.
Secondary Outcomes (1)
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.
change from baseline at day 5, 12,28, 42, 98.
Study Arms (2)
Active TLA Gut™ column
EXPERIMENTALThe active column contain an engineered protein with the ability to specifically bind the inflammatory cells.
Placebo TLA Gut™column
PLACEBO COMPARATORThe placebo column is identical to the active column except it does not contain the engineered protein that specifically bind the inflammatory cells.
Interventions
Five consecutive treatment sessions. The therapy will be administrated every second day.
Five consecutive treatment sessions. The placebo therapy will be administrated every second day.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of active, moderate-to-severe, Ulcerative Colitis.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Södersjukhuset
Stockholm, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Eberhardson, Dr
Karolinska Universitetssjukhuset 171 76 Stockholm
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2010
First Posted
April 1, 2010
Study Start
March 1, 2010
Primary Completion
October 1, 2011
Study Completion
November 1, 2011
Last Updated
August 21, 2013
Record last verified: 2010-03