UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005746 |
|---|---|
| Receipt number | R000006763 |
| Scientific Title | Analysis of the inhibition of liver fibrosis by interferon beta administration |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2011/06/08 18:53:45 |
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Basic information
Public title
Analysis of the inhibition of liver fibrosis by interferon beta administration
Acronym
The strategy for the control of liver fibrosis
Scientific Title
Analysis of the inhibition of liver fibrosis by interferon beta administration
Scientific Title:Acronym
The strategy for the control of liver fibrosis
Region
| Japan |
Condition
Condition
chronic hepatitis and liver cirrhosis type C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We attempt to evaluate the effectiveness and safety for the control of liver fibrosis in chronic hepatitis C and cirrhosis by using interferon beta administration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of the grade of liver fibrosis and biological marker for liver fibrosis (albmine, prothrombin time)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
interferon beta administration
Interventions/Control_2
glycyrrhizin administration
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
| 25 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
chronic hepatitis C (F2, F3), liver cirrhosis C
Key exclusion criteria
1. HIV infection
2. the patients who were performed liver transplantation
3. decompensated liver cirrhosis
4. autoimmuno hepatitis, alcoholic liver injury
5. pancytepenia (neutrophil<1500mm3, platelet<50000mm3, Hb<8g/dl)
6. autoimmuno disease and collagen disease
7. severe complication; renal disorder, severe diabates, pulmonary fibrosis, retinal hemorrhage
8. allergy for vaccination
9. allergy for drug and food
10. psychological disorder for example, depression
11. the patients who are not suitable for entry in this study by physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Murakami |
Organization
Kyoto University
Division name
Center for genomic medicine
Zip code
Address
Shogoinkawaharacho, 53, Sakyo-ku, Kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University
Division name
Center for genomic medicine
Zip code
Address
Shogoinkawaharacho, 53, Sakyo-ku, Kyoto
TEL
Homepage URL
Sponsor or person
Institute
Center for genomic medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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
| 2011 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | 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
| 2011 | Year | 06 | Month | 08 | Day |
Last modified on
| 2011 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006763
