Ulcerative ColitisPhase 1NCT01097590
A Study to Evaluate a Leukapheresis Treatment in Patients With Ulcerative Colitis
A Phase 1 study testing Active TLA Gut™ column in people with Ulcerative Colitis, run by IBD Column Therapies International AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Active TLA Gut™ column
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2010to Nov 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of active, moderate-to-severe, Ulcerative Colitis.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Placebo Controlled, Single Centre Study to Evaluate a Novel Leukapheresis Treatment in Patients With Ulcerative Colitis.
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.
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Active TLA Gut™ column, Placebo
- Keywords
- ulcerative colitis, leukapheresis treatment
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active TLA Gut™ columnDevice
Also called TLA Gut™
Five consecutive treatment sessions. The therapy will be administrated every second day.
PlaceboDevice
Five consecutive treatment sessions. The placebo therapy will be administrated every second day.
| Study group | Role | What they receive |
|---|---|---|
| Active TLA Gut™ column | Experimental | The active column contain an engineered protein with the ability to specifically bind the inflammatory cells. Receives: Device: Active TLA Gut™ column |
| Placebo TLA Gut™column | Placebo comparator | The placebo column is identical to the active column except it does not contain the engineered protein that specifically bind the inflammatory cells. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression level of MHC class II on antigen presenting cells.
The primary outcome will be assessed by flow cytometry.
Measured: 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.
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.
Measured: change from baseline at day 5, 12,28, 42, 98.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBD Column Therapies International AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Eberhardson, Dr, Principal investigator, Karolinska Universitetssjukhuset 171 76 Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097590
- Sponsor's protocol ID
- TLA001
- Other IDs
- 461:2009/501
- Status last verified
- Mar 2010
- First submitted
- 25 Mar 2010
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo Controlled, Single Centre Study to Evaluate a Novel Leukapheresis Treatment in Patients With Ulcerative Colitis.
- ClinicalTrials.gov ID
- NCT01097590
- Acronym / sponsor ID
- TLA001
- Conditions
- Ulcerative Colitis
- Keywords
- ulcerative colitis, leukapheresis treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- IBD Column Therapies International ABIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TLA Gut™ column | Experimental | Device: Active TLA Gut™ columnThe active column contain an engineered protein with the ability to specifically bind the inflammatory cells. |
| Placebo TLA Gut™column | Placebo comparator | Device: PlaceboThe placebo column is identical to the active column except it does not contain the engineered protein that specifically bind the inflammatory cells. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of active, moderate-to-severe, Ulcerative Colitis.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active TLA Gut™ columnAlso: TLA Gut™Five consecutive treatment sessions. The therapy will be administrated every second day. | Device | Active TLA Gut™ column |
| PlaceboFive consecutive treatment sessions. The placebo therapy will be administrated every second day. | Device | Placebo TLA Gut™column |
Primary outcome
Expression level of MHC class II on antigen presenting cells.
Time frame: change from baseline at day 5, 12, 28, 42 and 98.
The primary outcome will be assessed by flow cytometry.
1 secondary outcome
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.
Time frame: change from baseline at day 5, 12,28, 42, 98.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Eberhardson, Dr principal investigator
Karolinska Universitetssjukhuset 171 76 Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Active TLA Gut™ column in people with Ulcerative Colitis, run by IBD Column Therapies International AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression level of MHC class II on antigen presenting cells. (time frame: change from baseline at day 5, 12, 28, 42 and 98.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2013.