UMIN-CTR Clinical Trial

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
Email	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
Email	y_uchida@saitama-med.ac.jp

Sponsor
Institute	Department of Gastroenterology & Hepatology, Saitama Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020937