Ulcerative ColitisPhase 4NCT00947674
A Study of Leukocytapheresis (LCAP) in Patients With Ulcerative Colitis (UC)
A Phase 4 study testing Cellsorba EX in people with Ulcerative Colitis, run by Asahi Kasei Medical Co., Ltd. at 10 sites in 6 countries.
Trial summary
This is a prospective, randomized, double-blind, sham treatment controlled multicenter study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Cellsorba EX
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 10 sitesin 6 countries
- Study dates
- May 2009to Oct 2012
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed to have UC in the active stage based on clinical symptoms and findings from endoscopy
- Patients with pancolitis type or left-sided colitis type lesion of 15 cm or longer observed endoscopically
- Patients with Mayo score between 5 and 10
- Patients with Mayo sub-score (findings from flexible sigmoidoscopy) of 2 or 3
- Patients not having received any corticosteroids (referred to as steroids) (p.o., i.v., enema, suppository) within the past 6 weeks
Who cannot join
- Patients with a difficulty in peripheral vascular access
- Patients having received ACE inhibitor (at least 10 times of its half-life time for interval needed before initiating the treatment)
- Patients with toxic megacolon
- Patients with a malignant disease or its experience
- Patients with a severe cardiovascular disease (grade III or IV by the Classification of heart functions of the New York Heart Association (NYHA))
- Patients with a liver or kidney disease (AST(GOT) or ALT(GPT) or total bilirubin or creatinine level which is 2 or more times higher than the upper limit of normal (abbreviated as ULN, hereinafter)
Show all 15Show fewer
- Patients suspected to have or having HBV or HCV or HIV or pathogenic bacteria
- Patients on anticoagulant therapy or with abnormality in the blood coagulation system (PT or PTT levels which are 1.5 or more times higher than ULN
- Pregnant women or patients with possible pregnancy
- Breast feeding women
- Patients weighing 40 kg or less
- Patients with hemoglobin level of less than 6.5 mmol/L (10.5 g/dL)
- Patients with platelet count of less than 150 x 103/mm3, 150 x 109/L (15 x 104/mm3)
- Patients with white blood cell count of less than 3.5 x 109/L (3,500/mm3)
- Patients with hypotension (with systolic blood pressure of 80 mmHg or less)
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
About this study
Official title: Prospective, Randomized, Double-Blind, Sham Treatment Controlled Multicenter Study to Evaluate Efficacy and Safety of Cellsorba™EX Used for Leukocytapheresis (LCAP) in Patients With Steroid-Free, Active Ulcerative Colitis
This is a prospective, randomized, double-blind, sham treatment controlled multicenter study.
- Conditions
- Ulcerative Colitis
- Being tested
- Cellsorba EX
- Keywords
- Cellsorba EX
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellsorba EXDevice
conduct treatment twice a week for 3 weeks and once a week for 4 weeks, total 10 times
| Study group | Role | What they receive |
|---|---|---|
| Cellsorba EX | Experimental | Not described Receives: Device: Cellsorba EX |
| Sham treatment | Sham comparator | Not described Receives: Device: Cellsorba EX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
Measured: at 8th week
Secondary outcomes (1)
Remission, Mayo scores, Mucosal healing, CRP
Measured: at 8th and 16th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2012
- Study completionOct 2012
Why it stopped: short of enrollment
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asahi Kasei Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asahi Kasei Medical Europe GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947674
- Sponsor's protocol ID
- NEWS80
- Status last verified
- Dec 2012
- First submitted
- 27 Jul 2009
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-Blind, Sham Treatment Controlled Multicenter Study to Evaluate Efficacy and Safety of Cellsorba™EX Used for Leukocytapheresis (LCAP) in Patients With Steroid-Free, Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00947674
- Acronym / sponsor ID
- NEWS80
- Conditions
- Ulcerative Colitis
- Keywords
- Cellsorba EX
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: short of enrollment
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Asahi Kasei Medical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Asahi Kasei Medical Europe GmbH
- Study start
- May 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Jul 2009 (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.
This is a prospective, randomized, double-blind, sham treatment controlled multicenter study.
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 |
|---|---|---|
| Cellsorba EX | Experimental | Device: Cellsorba EX |
| Sham treatment | Sham comparator | Device: Cellsorba EX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed to have UC in the active stage based on clinical symptoms and findings from endoscopy
- Patients with pancolitis type or left-sided colitis type lesion of 15 cm or longer observed endoscopically
- Patients with Mayo score between 5 and 10
- Patients with Mayo sub-score (findings from flexible sigmoidoscopy) of 2 or 3
- Patients not having received any corticosteroids (referred to as steroids) (p.o., i.v., enema, suppository) within the past 6 weeks
Key exclusion criteria (15 listed)
- Patients with a difficulty in peripheral vascular access
- Patients having received ACE inhibitor (at least 10 times of its half-life time for interval needed before initiating the treatment)
- Patients with toxic megacolon
- Patients with a malignant disease or its experience
- Patients with a severe cardiovascular disease (grade III or IV by the Classification of heart functions of the New York Heart Association (NYHA))
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 |
|---|---|---|
| Cellsorba EXconduct treatment twice a week for 3 weeks and once a week for 4 weeks, total 10 times | Device | Cellsorba EX, Sham treatment |
Primary outcome
Clinical response
Time frame: at 8th week
1 secondary outcome
Remission, Mayo scores, Mucosal healing, CRP
Time frame: at 8th and 16th week
Results and safety
The study was stopped early (reason given: short of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cellsorba EX in people with Ulcerative Colitis, run by Asahi Kasei Medical Co., Ltd. at 10 sites in 6 countries.
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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Japan, Sweden, United Kingdom, Czechia and 1 more country. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: short of enrollment). Results are not available in the source record.
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?
Clinical response (time frame: at 8th week). 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 6 Dec 2012.