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
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

Apheresis Research Institute
Stadtwaldgürtel 77
Cologne
50935
Germany

Phone +49-221-406 317 0
Email afi@apheresis-research.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymMICELL-UC
Study objectivesStudy 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) studiedRefractory, chronic active ulcerative colitis
InterventionPlease 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 typeOther
Primary outcome measurePrimary 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 measuresSecondary 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 date01/11/2004
Completion date31/12/2006
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
Age groupNot Specified
SexBoth
Target number of participantsPlanned number of recruitment added as of 8 June 2007: 95 (less than 50% achieved).
Key inclusion criteria1. 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 criteriaExclusion 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 enrolment01/11/2004
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • Germany

Study participating centre

Apheresis Research Institute
Cologne
50935
Germany

Sponsor information

Asahi Kasei Medical Europe GmbH (Germany)
Industry

Lyoner strasse 44-48
Frankfurt
60528
Germany

ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan