UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002415 |
|---|---|
| Receipt number | R000002958 |
| Scientific Title | A clinical research on the amount of liver fat when treated with the combination therapy of interferon and DFPP (Double filtration plasmapheresis) measured by MRS(Magenetic Resonance Spectroscopy) |
| Date of disclosure of the study information | 2010/01/01 |
| Last modified on | 2013/09/02 08:58:37 |
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Basic information
Public title
A clinical research on the amount of liver fat when treated with the combination therapy of interferon and DFPP (Double filtration plasmapheresis) measured by MRS(Magenetic Resonance Spectroscopy)
Acronym
Clinical research on the amount of liver fat when treated with the combination therapy of interferon and DFPP.
Scientific Title
A clinical research on the amount of liver fat when treated with the combination therapy of interferon and DFPP (Double filtration plasmapheresis) measured by MRS(Magenetic Resonance Spectroscopy)
Scientific Title:Acronym
Clinical research on the amount of liver fat when treated with the combination therapy of interferon and DFPP.
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the mechanism of viral eradication therapy with the combination of DFPP and interferon by measuring liver fat content before and after DFPP with MRS.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of liver fat before and at the ninth day of DFPP.
Key secondary outcomes
1) Comparison of HCV-RNA before, 4weeks and 12weeks after the initiation of DFPP.
2) Comparison of the amount of liver fat 4weeks and 12weeks after the initiation of DFPP.
3) Comparison of blood triglyceride and serum ferritin before, 4weeks and 12weeks after the initiation of DFPP.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
combined with DFPP
Interventions/Control_2
combined without DFPP
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
Diagnosed chronic hepatitis C patients.
Patients whose written informed consents are obtained.
Key exclusion criteria
1) Patients ever experienced shock during extracorporeal therapy.
2) Patients who has previous history of hypersensitivity for biological pruducts such as interferon and vaccines.
3) Patients who are now being administered shoo-saikoto.
4) Patients with autoimmune hepatitis.
5) Patients ever experienced a hyper-sensitivity against nucleoside analogues( aciclovir, ganciclovir, vidarabine etc).
6) Patients with uncontrollable cardiac disorder( myocardial infarction, heart failure, arrhythmia) .
7) Patients with hemoglobinopathy (thalassemia, drepanocytic anemia).
8) Patients with chronic renal failure, or whose creatine clearances are under 50mL/min.
9) Patients with serious depression, serious mental state such as suicidal ideation, suicide attempt, or with those histories.
10) Patients with severe hepatic dysfunction.
11) Patients whose platelet numbers are less than 50,000/L upon registration or before the first DFPP.
12) Patients whose fibrinogen levels are less than 100mg/dL upon registration or before the first DFPP.
13) Patients installed or planted with metals( including metal powder) , cardiac pacemaker, implantable nerve stimulator, implantable defibrillator, or cerebrospinal drain tube.
14) Patients who had participated in other clinical researches or clinical trials.
15) Pregnant women, nursing women, or possible pregnant.
16) Additionally, patients who had been judged as unsuitable for this clinical research by the doctors.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Kaneko |
Organization
Kanazawa University Hospital
Division name
Department of Gastrenterology
Zip code
Address
13-1 Takara-Machi, Kanazawa, Ishikawa
TEL
076-265-2233
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Yamashita |
Organization
Kanazawa University Hospital
Division name
Department of Gastrenterology
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2861
Homepage URL
Sponsor or person
Institute
Kanazawa University Hospital
Department of Gastroenterology
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
金沢大学病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 31 | Day |
Last modified on
| 2013 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002958
