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| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| Public title | 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 |
| Scientific title | |
| Acronym | MICELL-UC |
| Serial number at source | 1.6 - 07/2004 |
| Study hypothesis | 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). |
| Lay summary | |
| Ethics approval |
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) |
| Study design | Randomised controlled trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Refractory, chronic active ulcerative colitis |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/11/2004 |
| Anticipated end date | 31/12/2006 |
| Status of trial | Stopped |
| Patient information material | |
| Target number of participants | Planned number of recruitment added as of 8 June 2007: 95 (less than 50% achieved). |
| Interventions |
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) |
| Primary outcome measure(s) |
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 measure(s) |
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. |
| Sources of funding |
Source of funding added as of 8 June 2007:
Asahi Kasei Medical Europe GmbH, Lyoner Strasse 44-48, 60528 Frankfurt (Germany) |
| Trial website | |
| Publications | |
| Contact name | Dr Reinhard Klingel |
| Address |
Apheresis Research Institute
Stadtwaldgürtel 77 |
| City/town | Cologne |
| Zip/Postcode | 50935 |
| Country | Germany |
| Tel | +49-221-406 317 0 |
| Fax | +49-221-406 317 8 |
| afi@apheresis-research.de | |
| Sponsor | Asahi Kasei Medical Europe GmbH (Germany) |
| Address | Lyoner strasse 44-48 |
| City/town | Frankfurt |
| Zip/Postcode | 60528 |
| Country | Germany |
| Date applied | 28/10/2004 |
| Last edited | 13/12/2007 |
| Date ISRCTN assigned | 17/01/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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