UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the efficacy of sofosbuvir/velpatasvir and ribavirin in Japanese hepatitis C patients who failed direct-acting antiviral agents: a prospective study in real life settings.
Title of the study (Brief title)	The efficacy of sofosbuvir/velpatasvir and ribavirin in Japanese hepatitis C patients who failed direct-acting antiviral agents.
Region	Japan

Condition
Condition	cirrhotic and non cirrhotic patients with hepatitis C virus
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Identifying the predictive factors of virological response in sofosbuvir/velpatasvir and ribavirin treatment for the patients who failed direct-acting antiviral agents.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	sustained virological response (SVR) at 12 weeks after the end of treatment (EOT)
Key secondary outcomes	SVR at 24 weeks after the EOT incidence rate of adverse events during treatment

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	Not applicable
Gender	Male and Female
Key inclusion criteria	chronic hepatitis C and compensated cirrhotic patients with HCV RNA
Key exclusion criteria	decompensated cirrhosis severe anemia
Target sample size	150

Research contact person
Name of lead principal investigator	Fumitaka Suzuki
Organization	Toranomon Hospital
Division name	hepatology
Address	2-2-2, Toranomon, Minato-ku, Tokyo
TEL	03-3588-1111
Email	fumitakas@toranomon.gr.jp

Public contact
Name of contact person	Hitomi Sezaki
Organization	Toranomon Hospital
Division name	hepatology
Address	2-2-2, Toranomon, Minato-ku, Tokyo
TEL	03-3588-1111
Homepage URL
Email	hitomis@mx1.harmonix.ne.jp

Sponsor
Institute	Toranomon Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	虎の門病院(東京都)

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2019 Year 01 Month 28 Day
Anticipated trial start date	2019 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	combination tablet of sofosbuvir/velpatasvir(400mg/100mg) one tablet once daily for 24 weeks. ribavirin 600-1000mg divided twice daily for 24 weeks. Evaluating the association with baseline characteristics (viral factors and host factors) and virological response.

Management information
Registered date	2019 Year 01 Month 29 Day
Last modified on	2019 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040681