UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between viral clearance and prevention of carcinogenesis in patients with chronic hepatitis genotype2 treated with sofosuvubir plus ribavirin combination therapy
Title of the study (Brief title)	Efficacy of sofosuvubir plus ribavirin combination therapy for patients with chronic hepatitis genotype 2
Region	Japan

Condition
Condition	Chronic hepatitis C
Classification by specialty	Hepato-biliary-pancreatic medicine Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To analyze the predictive factors associated with virologic response in sofosuvubir and ribavirin combination therapy for genotype 2 infected chronic hepatitis C patients. To analyze the incidence of hepatocellular carcinoma after sofosuvubir and ribavirin combination therapy prospectively.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Sustained virologic response rate at 12 weeks after the completion of treatment
Key secondary outcomes	1. Changes in serum HCV RNA during treatment and follow-up duration 2. Changes in hematological and biochemical test during treatment and follow-up duration 3. Changes in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration 4. Changes in fibrosis during treatment and follow-up duration by fibroscan 5. Analysis of the relationship between ITPA(Inosine triphosphate pyrophosphatase)gene polymorphism and the treatment response 6. The resistance profile of sofosubuvir and the concentration of ribavirin before the treatment, during the treatment, and after the treatment. 7. The carciogenic rate of hepatocellular carcinoma after the treatment

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	The patients were treated with sofosubuvir plus ribavirin combination therapy for 12 weeks.
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	18 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with chronic hepatitis C who were treated with sofosubuvir plus ribavirin combination therapy or other new agents.
Key exclusion criteria	1. History of allergy to sofosubuvir, Ribavirin, and other nucleotide analog. 2. severe renal disorder or chronic renal failure on hemodialysis 3. medication with carbamazepine, phenytoin, rifampicin, St. John's wort 4. pregnant woman or lactating mother 5. poorly controlled heart disease 6. hemoglobinopathy 7. severe depression 8. autoimmune hepatitis 9. Hepatocellular carcinoma, or other malignant tumor 10. severe liver disorder (T-Bil>3.0mg/dL, and/or PT%<70%, and/or Alb<3.4g/dL) 11. Judged by investigator not to be appropriate for inclusion in this study
Target sample size	300

Research contact person
Name of lead principal investigator	Masanori Atsukawa
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Gastroenterology
Address	1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL	0476-99-1111
Email	atsukawa-nms@umin.ac.jp

Public contact
Name of contact person	Masanori Atsukawa
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Gastroenterology
Address	1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL	0476-99-1111
Homepage URL
Email	atsukawa-nms@umin.ac.jp

Sponsor
Institute	Nippon Medical School Chiba Hokusoh Hospital
Institute
Department

Funding Source
Organization	Nippon Medical School Chiba Hokusoh Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

Other related organizations
Co-sponsor	Nippon Medical School Nippon Medical School Musashikosugi Hospital Shinmatsudo Central General Hospital Ootakanomori Hospital Jikei University Kashiwa Hospital Hakujikai Memorial Hospital
Name of secondary funｄer(s)

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

日本医科大学千葉北総病院（千葉県）Nippon Medical School Chiba Hokusoh Hospital 日本医科大学付属病院(東京都）Nippon Medical School (Tokyo) 日本医科大学武蔵小杉病院（神奈川県）Nippon Medical School Musashikosugi Hospital (Kanagawa)　　　　　　　　　 新松戸中央総合病院（千葉県）Shinmatsudo Central General Hospital (Chiba) おおたかの森病院（千葉県）Ootakanomori Hospital (Chiba)　　　　　　　 　　 東京慈恵会医科大学付属柏病院（千葉県）Jikei University Kashiwa Hospital (Chiba) 東京慈恵会医科大学葛飾医療センター（東京都）Jikei University Katsushika Medical center(Tokyo ) 博慈会記念総合病院（東京都）Hakujikai Memorial Hospital (Tokyo)

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 22 Day
Anticipated trial start date	2015 Year 07 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 28 Day
Last modified on	2017 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021372