UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018453 |
|---|---|
| Receipt number | 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 21:16:36 |
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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
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
atsukawa-nms@umin.ac.jp
Sponsor or person
Institute
Nippon Medical School Chiba Hokusoh Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021372
