A multicenter, randomized, double-blind, placebo-controlled investigation of long-term safety and efficacy of LCAP (leukocytapheresis using "Cellsorba FX") in patients with refractory, chronic active ulcerative colitis
ISRCTN | ISRCTN57616765 |
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DOI | https://doi.org/10.1186/ISRCTN57616765 |
Secondary identifying numbers | 1.6 - 07/2004 |
- Submission date
- 28/10/2004
- Registration date
- 17/01/2005
- Last edited
- 13/12/2007
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Reinhard Klingel
Scientific
Scientific
Apheresis Research Institute
Stadtwaldgürtel 77
Cologne
50935
Germany
Phone | +49-221-406 317 0 |
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afi@apheresis-research.de |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study acronym | MICELL-UC |
Study objectives | Study hypothesis added as of 8 June 2007: Assessment of long-term safety and efficacy of leukocytapheresis with Cellsorba FX in comparison to sham-leukocytapheresis for patients with refractory, chronic active ulcerative colitis (CAI 6-10). |
Ethics approval(s) | Ethics approval information added as of 8 June 2007: Approvals of the following ethics committees were obtained on 19 August 2004: 1. Hannover Medical School (MHH) 2. University (LMU) of Munich 3. University of Erlangen 4. Medical association of Mecklenburg-Western Pomerania (Rostock) 5. University of Munster 6. Charité, University of Berlin 7. Medical association of Rhineland-Palatinate (Mainz) |
Health condition(s) or problem(s) studied | Refractory, chronic active ulcerative colitis |
Intervention | Please note that this study was terminated on 25 April 2007 due to unsatisfactory patient enrolment. Interventions provided at registration: Extracorporeal leukocytapheresis (LCAP; verum group) versus sham-leukocytaphersis (placebo group) |
Intervention type | Other |
Primary outcome measure | Primary outcome measures added as of 8 June 2007: The primary efficacy parameter is the 7-item Clinical Activity Index (CAI). A sum score will be calculated summing up all items that are differently weighted. The range of the sum score is 0 to 29 points. A sum score of less than four (or less than or equal to 4) points at the end of the therapy will be assessed as remission or success. |
Secondary outcome measures | Secondary outcome measures added as of 8 June 2007: 1. Inflammatory Bowel Disease Questionnaire (IBDQ), German translation. This questionnaire consists of four domains and 32 items. Domains are simply the sum of specific items, i.e. bowel symptoms, systemic symptoms, emotional functions and social functions. 2. Endoscopic Index (EI), which includes 4 items with different weights. The range of the sum score is 0 to 12 points. 3. Cumulative steroid dose over intensive and maintenance phase. 4. CAI, item-wise analysis. |
Overall study start date | 01/11/2004 |
Completion date | 31/12/2006 |
Reason abandoned (if study stopped) | The trial will be terminated due to unsatisfactory patient enrolment: during the scheduled period of 24 months, less than 50% of patient enrolment has been completed. |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Both |
Target number of participants | Planned number of recruitment added as of 8 June 2007: 95 (less than 50% achieved). |
Key inclusion criteria | 1. Ulcerative colitis with chronic active disease state 2. Colitis endoscopically covering at least 15 cm 3. Clinical Activity Index: 6-10 4. No long term remission using combined standard therapy including 5-Aminosalicylate (ASA), prednisolone and/or azathioprine 5. Cumulative steroid dosage within the last 2 months in total at least 600 mg 6. Steroid dosage constant 10 mg per day during 2 weeks before start of treatment (pre-treatment phase) 7. Negative test of pregnancy for female patients 8. Patient is able to understand and sign informed consent |
Key exclusion criteria | Exclusion criteria added as of 8 June 2007: 1. Age < 18 or ≥ 80 years 2. Effective response to conventional Ulcerative Colitis (UC) therapy 3. Diagnosis of proctitis or mild UC (usually controlled by aminosalicylates and suppository steroid therapies) 4. Active symptoms which would exclude the patient from undergoing routine diagnostic colonoscopy i.e. evidence of active bowel obstruction, intestinal perforation, significant GI hemorrhage or known high-grade stricture 5. Body weight is less than 40 kg 6. Any malignant disease currently or in history 7. Renal failure and/ or hepatic failure (Glutamate Oxalate Transferase [GOT], Glutamic-Pyruvic Transaminase [GPT], total billirubin, creatinine > twice the normal value) 8. Chronic hypotension (80 mmHg or lower systolic) 9. Therapeutic anticoagulation (Cumarine) or coagulation disorder 10. Active bacterial or viral infection, especially acute or chronic Hepatitis B or C virus infection, or HIV infection 11. Severe cardiovascular disease (New York Heart Association [NYHA] III-IV or Canadian Cardiovascular Society [CCS] III-IV), which would not permit any extracorporeal treatment 12. Breast feeding, pregnancy, drug abuse or dementia 13. Participation in another clinical study in the last 3 months |
Date of first enrolment | 01/11/2004 |
Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Apheresis Research Institute
Cologne
50935
Germany
50935
Germany
Sponsor information
Asahi Kasei Medical Europe GmbH (Germany)
Industry
Industry
Lyoner strasse 44-48
Frankfurt
60528
Germany
https://ror.org/040cmp171 |
Funders
Funder type
Industry
Source of funding added as of 8 June 2007:
No information available
Asahi Kasei Medical Europe GmbH, Lyoner Strasse 44-48, 60528 Frankfurt (Germany)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |