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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018759
Receipt No. R000021702
Scientific Title Analysis of efficacy and safety of interferon-free therapy for recurrent hepatitis C after liver transplantation
Date of disclosure of the study information 2015/09/01
Last modified on 2017/02/08

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Basic information
Public title Analysis of efficacy and safety of interferon-free therapy for recurrent hepatitis C after liver transplantation
Acronym Interferon-free therapy for posttransplant hepatitis C
Scientific Title Analysis of efficacy and safety of interferon-free therapy for recurrent hepatitis C after liver transplantation
Scientific Title:Acronym Interferon-free therapy for posttransplant hepatitis C
Region
Japan

Condition
Condition hepatitis C after liver transplantation
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. To clarify the efficacy and safety of interferon-free therapy for recurrent hepatitis C after liver transplantation.
2. To evaluate the impact on quality of life in intervention with interferon-free treatment.
3. To evaluate drug-drug interactions.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy and safety of interferon-free therapy for recurrent hepatitis C after liver transplantation
Key secondary outcomes 1. Impact on quality of life in intervention with interferon-free treatment
2. Drug-drug interactions

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Recurrent hepatitis C after liver transplantation
2. Chronic hepatitis or compensated liver cirrhosis
3. 20 years old and over
4. Written informed concent for participation in this study is obtained
Key exclusion criteria Patients without ability to understand the informed concent
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihide Ueda
Organization Kyoto University Hospital
Division name Gastroenterology and Hepatology
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL 81-75-751-4319
Email yueda@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihide Ueda
Organization Kyoto University Hospital
Division name Gastroenterology and Hepatology
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL 81-75-751-4319
Homepage URL
Email yueda@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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
2015 Year 09 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 Enrolling by invitation
Date of protocol fixation
2015 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will clarify the efficacy and safety of interferon-free therapy for recurrent hepatitis C after liver transplantation in Kyoto University, and analyze the predictive factors of the efficacy and safety. We will also evaluate the impact on quarily of life in intervention with interferon-free treatment.

Management information
Registered date
2015 Year 08 Month 21 Day
Last modified on
2017 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021702

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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