UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017755 |
|---|---|
| Receipt number | R000020567 |
| Scientific Title | Study of drug resistance virus in Sofosbuvir/Ribavirin combination therapy to genotype 2 chronic hepatitis |
| Date of disclosure of the study information | 2015/06/10 |
| Last modified on | 2019/06/04 22:44:18 |
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Basic information
Public title
Study of drug resistance virus in Sofosbuvir/Ribavirin combination therapy to genotype 2 chronic hepatitis
Acronym
Study of drug resistance virus in Sofosbuvir/Ribavirin combination therapy
Scientific Title
Study of drug resistance virus in Sofosbuvir/Ribavirin combination therapy to genotype 2 chronic hepatitis
Scientific Title:Acronym
Study of drug resistance virus in Sofosbuvir/Ribavirin combination therapy
Region
| Japan |
Condition
Condition
Genotype 2 chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, direct-acting antiviral agents (DAAs) which specifically effect for HCV virus is developed. Drug resistance virus influence the drug efficacy of DAAs. It is deeply associated with viral breakthrough in Daclatasvir/Asunaprevir treatment of genotype type 1 hepatitis C. Drug resistance virus is expected to be associated with the outcome of Sofosbuvir/Ribavirin (SOF/RBV) combination therapy for genotype 2 hepatitis C. But these factors has not been reported on the real world clinical setting. It is important to clarify the association between SOF/RBV and drug resistance virus.
Basic objectives2
Others
Basic objectives -Others
We study the drug resistance virus in genotype 2 chronic hepatitis patients treated with Sofosbuvir/Ribavirin combination therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The dynamic state of drug resistance virus is studied before pre-treatment and viral breakthrough.
Key secondary outcomes
HCV RNA levels are assessed at pre treatment and 2, 4, 8, 12weeks or end of treatment and at 12 and 24 weeks after completion of treatment, and routine biochemical and hematological tests are also assessed.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible patients are 20 to 85 years old of genotype 2 chronic hepatitis C patients. Patients are prescribed p.o. sofosbuvir of 400 mg/day combined with ribavirin of 600-1000 mg/day for 12 weeks.
Key exclusion criteria
Patients with decompensated liver disease, coinfection with hepatitis B virus or human immunodeficiency virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's disease are excluded. Patients with uncontrollable hypertension or diabetes mellitus and those with a history of alcohol abuse are also excluded.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kanji |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465, Kajii-chou, Kawaramachi, Kamigyou-ku,Kyoto 602-0841, Japan
TEL
075-251-5519
sumida@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Fujii |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465, Kajii-chou, Kawaramachi, Kamigyou-ku,Kyoto 602-0841, Japan
TEL
075-251-5519
Homepage URL
http://www.f.kpu-m.ac.jp/k/syokanai/
fuhideki@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine, Department of Molecular Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
None
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
ethical committee
Address
465, Kajii-chou, Kawaramachi, Kamigyou-ku,Kyoto 602-0841, Japan
Tel
0752515337
rinri@koto.kpu-m.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 | 10 | 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 | 05 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
The dynamic state of drug resistance virus is studied before pre-treatment and viral breakthrough.
HCV RNA levels are assessed at pre treatment and 2, 4, 8, 12weeks or end of treatment and at 12 and 24 weeks after completion of treatment, and routine biochemical and hematological tests are also assessed.
Management information
Registered date
| 2015 | Year | 05 | Month | 31 | Day |
Last modified on
| 2019 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020567
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
