UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018089 |
|---|---|
| Receipt number | R000020937 |
| Scientific Title | Efficacy of sofosbuvir and ribavirin therapy in patients with genotype 2 hepatitis C virus: Significance of variants associated with resistance in NS3, NS5A and NS5B region |
| Date of disclosure of the study information | 2015/06/26 |
| Last modified on | 2020/07/04 09:30:23 |
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Basic information
Public title
Efficacy of sofosbuvir and ribavirin therapy in patients with genotype 2 hepatitis C virus: Significance of variants associated with resistance in NS3, NS5A and NS5B region
Acronym
Assessment of NS3, NS5A and NS5B amino acid mutations in genoytpe 2 HCV
Scientific Title
Efficacy of sofosbuvir and ribavirin therapy in patients with genotype 2 hepatitis C virus: Significance of variants associated with resistance in NS3, NS5A and NS5B region
Scientific Title:Acronym
Assessment of NS3, NS5A and NS5B amino acid mutations in genoytpe 2 HCV
Region
| Japan |
Condition
Condition
the patients infected with genotype 2 HCV who received combination therapy with sofosbvir and rivabirin.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve the therapeutic effects of antiviral therapy in chronic hepatitis C genotype 2 by evaluated the kinetics of RAVs in NS3, NS5A and NS5B region of HCV.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the efficacy of antiviral therapy at end of treatment and 4 week after.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients infected with HCV genotype 2
Key exclusion criteria
the patients infected with HCV other than genotype 2
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Mochida |
Organization
Saitama Medical University
Division name
Department of Gastroenterology & Hepatology
Zip code
3580495
Address
38 Morohongo, Moroyama-Machi, Iruma-Gun, Saitama
TEL
049-276-1198
smochida@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihito |
| Middle name | |
| Last name | Uchida |
Organization
Saitama Medical University
Division name
Department of Gastroenterology & Hepatology
Zip code
3580495
Address
38 Morohongo, Moroyama-Machi, Iruma-Gun, Saitama
TEL
049-276-1198
Homepage URL
y_uchida@saitama-med.ac.jp
Sponsor or person
Institute
Department of Gastroenterology & Hepatology,
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan agency for medical research and development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Institutional Review Board of Saitama Medical University Hospital
Address
38 Morohongo, Moroyama-Machi, Iruma-Gun, Saitama
Tel
049-276-1125
hirb@saitama-med.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 | 26 | 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
40
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 | 06 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We collect patients' serum samples at start and 1, 2 and 4 weeks of treatment and evaluate the variants associated with resistance in NS3, NS5A and NS5B region. When viral RNA are not negative at 4 weeks of treatment, we continue the serum sampling and evaluation every 2 weeks. In the cases that viral RNA are negative at 4 weeks of treatment, sera are collected when viral RNA are positive during anti viral therapy.
Management information
Registered date
| 2015 | Year | 06 | Month | 25 | Day |
Last modified on
| 2020 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020937
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
