UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010207 |
|---|---|
| Receipt number | R000011956 |
| Scientific Title | Efficacy of Intensive Granulocyte and Monocyte Apheresis in Patients with Pouchitis |
| Date of disclosure of the study information | 2013/03/11 |
| Last modified on | 2014/04/11 18:41:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of Intensive Granulocyte and Monocyte Apheresis in Patients with Pouchitis
Acronym
Efficacy of Intensive Granulocyte and Monocyte Apheresis in Patients with Pouchitis
Scientific Title
Efficacy of Intensive Granulocyte and Monocyte Apheresis in Patients with Pouchitis
Scientific Title:Acronym
Efficacy of Intensive Granulocyte and Monocyte Apheresis in Patients with Pouchitis
Region
| Japan |
Condition
Condition
Pouchitis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of intensive GMA in patients with Pouchitis after total proctocolectomy and IPAA
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Remission rate (PDAI<7)
Key secondary outcomes
1. Reduction of fecal markers (calprotectin, lactoferrin), C-reactive protein (CRP), and white blood cell count (WBC).
2. Improvement of endoscopic index reflecting healing of pouchitis lesions.
3. Reduction of the PDAI score
4. Correlation of fecal markers with the PDAI score
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients to receive 10 GMA sessions at a frequency of 2 sessions per consecutive week
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with a current episode of active pouchitis defined as having a pouchitis disease activity index of > 7 after IPAA for UC as confirmed by endoscopy and histology.
2.Patients who have endoscopically detectable lesion.
3.Patients with pouchitis refractory to antibiotics including metronidazole, and ciprofloxacin.
Key exclusion criteria
1.Patients whose granulocyte number is under 2,000/mm3
2.Patients who have or is suspected severe infections.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Watanabe, M.D., Ph.D. |
Organization
Faculty of Medicine, University of Tokyo
Division name
Surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-8653
toshwatanabe@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Watanabe, M.D., Ph.D. |
Organization
Faculty of Medicine, University of Tokyo
Division name
Surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-8653
Homepage URL
toshwatanabe@yahoo.co.jp
Sponsor or person
Institute
Faculty of Medicine, University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 11 | Day |
Last modified on
| 2014 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011956
