UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013712 |
|---|---|
| Receipt number | R000016008 |
| Scientific Title | Advantages of Fecal Lactoferrin Measurement during Granulocyte and Monocyte Adsorptive Apheresis Therapy in Ulcerative Colitis |
| Date of disclosure of the study information | 2014/04/14 |
| Last modified on | 2016/04/14 18:29:50 |
* 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
Advantages of Fecal Lactoferrin Measurement during Granulocyte and Monocyte Adsorptive Apheresis Therapy in Ulcerative Colitis
Acronym
Advantages of Fecal Lactoferrin Measurement during Granulocyte and Monocyte Adsorptive Apheresis Therapy in Ulcerative Colitis
Scientific Title
Advantages of Fecal Lactoferrin Measurement during Granulocyte and Monocyte Adsorptive Apheresis Therapy in Ulcerative Colitis
Scientific Title:Acronym
Advantages of Fecal Lactoferrin Measurement during Granulocyte and Monocyte Adsorptive Apheresis Therapy in Ulcerative Colitis
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to assess if fecal lactoferrin can be employed to predict or estimate the effect of GMA in patients with UC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of fecal lactoferrin concentrations between the GMA-responder and -nonresponder groups
Key secondary outcomes
Base
Study type
Interventional
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
GMA treatment
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
patients with steroid-refractory UC or steroid-dependent UC were recruited in this study and were scheduled to undergo GMA.
Key exclusion criteria
severe infectious disease
number of granulocyte <=2000/mm3
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fuminao Takeshima |
Organization
Nagasaki University Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
1-7-1 Sakamoto, Nagasaki, 852-8501, Japan
TEL
095-819-7481
ftake@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fuminao Takeshima |
Organization
Nagasaki University Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
1-7-1 Sakamoto, Nagasaki, 852-8501, Japan
TEL
095-819-7481
Homepage URL
ftake@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
| 2014 | Year | 04 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 03 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 14 | Day |
Last modified on
| 2016 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016008
