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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018453
Receipt No. R000021372
Scientific Title Relationship between viral clearance and prevention of carcinogenesis in patients with chronic hepatitis genotype2 treated with sofosuvubir plus ribavirin combination therapy
Date of disclosure of the study information 2015/07/29
Last modified on 2017/07/29

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Basic information
Public title Relationship between viral clearance and prevention of carcinogenesis in patients with chronic hepatitis genotype2 treated with sofosuvubir plus ribavirin combination therapy
Acronym Efficacy of sofosuvubir plus ribavirin combination therapy for patients with chronic hepatitis genotype 2
Scientific Title Relationship between viral clearance and prevention of carcinogenesis in patients with chronic hepatitis genotype2 treated with sofosuvubir plus ribavirin combination therapy
Scientific Title:Acronym 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
1st name
Middle name
Last name Masanori Atsukawa
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Division of Gastroenterology
Zip code
Address 1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL 0476-99-1111
Email atsukawa-nms@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Atsukawa
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Division of Gastroenterology
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2015 Year 07 Month 22 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000021372

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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