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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005746
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Center for genomic medicine, Kyoto University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006763

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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