UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of peg-IFN+RBV combined therapy in failure of direct antiviral agents therapy for chronic hepatitis C and liver cirrhosis C
Acronym	Efficacy and safety of peg-IFN+RBV combined therapy in failure of direct antiviral agents therapy for chronic hepatitis C and liver cirrhosis C
Scientific Title	Efficacy and safety of peg-IFN+RBV combined therapy in failure of direct antiviral agents therapy for chronic hepatitis C and liver cirrhosis C
Scientific Title:Acronym	Efficacy and safety of peg-IFN+RBV combined therapy in failure of direct antiviral agents therapy for chronic hepatitis C and liver cirrhosis C
Region	Japan

Condition
Condition	Chronic hepatitis and compensated liver cirrhosis, type C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of efficacy and safety for pegIFN plus RBV combined therapy against chronic hepatitis and compensated liver cirrhosis type C
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sustained virological response
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	Medicine
Interventions/Control_1	PegIFN plus RBV
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	good informed patients
Key exclusion criteria	un-tolerable for combined therapy de compensated liver cirrhosis
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shinji Shimoda Middle name Last name Shinji Shimoda
Organization	Faculty of Medicine, Kyushu University
Division name	Dept. of Medicine and Biosystemic Science
Zip code	8128582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5231
Email	sshimoda@intmed1.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Shinji Shimoda Middle name Last name Shinji Shimoda
Organization	Faculty of Medicine, Kyushu University
Division name	Dept. of Medicine and Biosystemic Science
Zip code	8128582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5231
Homepage URL
Email	sshimoda@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute	Faculty of Medicine, Kyushu University Dept. of Medicine and Biosyste
Institute
Department

Funding Source
Organization	Faculty of Medicine, Kyushu University Dept. of Medicine and Biosyste
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	Kyushu University Hospital
Address	Fukuoka City, Higashi-Ku
Tel	092-642-5228
Email	sshimoda@intmed1.med.kyushu-u.ac.jp

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 06 Month 20 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	0
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	2015 Year 06 Month 18 Day
Date of IRB	2015 Year 06 Month 01 Day
Anticipated trial start date	2015 Year 06 Month 18 Day
Last follow-up date	2019 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 06 Month 20 Day
Last modified on	2019 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020839