UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between sofosbuvir + velpatasvir + ribavirin combination therapy and drug resistance mutation for DAA treatment failure cases
Acronym	Relationship between sofosbuvir + velpatasvir + ribavirin combination therapy and drug resistance mutation for DAA treatment failure cases
Scientific Title	Relationship between sofosbuvir + velpatasvir + ribavirin combination therapy and drug resistance mutation for DAA treatment failure cases
Scientific Title:Acronym	Relationship between sofosbuvir + velpatasvir + ribavirin combination therapy and drug resistance mutation for DAA treatment failure cases
Region	Japan

Condition
Condition	Chronic hepatitis C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	We plan to collect clinical data of patients who are treated with sofosbuvir + velpatasvir + ribavirin at our hospital and clarify the actual condition of the treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The significance of this study is to collect clinical data on treatment and to clarify the association with drug resistance mutations.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients over 20 years old
Key exclusion criteria	Patients who cannot regularly visit the outpatient department of hepatobiliary-pancreatic medicine. Patients with hepatocellular carcinoma. Patients with impaired renal function (eGFR 30 ml / min / less than 1.73 m2). Patients who are allergic to this drug. Patients who are taking contraindications for this study drugs. Patients who are judged by the attending physician to possibly impair patient safety.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Akihiro Middle name Last name Tamori
Organization	School of Medicine and Graduate school of Medicine Osaka City University
Division name	Department of Hepatology
Zip code	545-8585
Address	1-4-3, Asahimachi, Abeno, Osaka 545-8585, JAPAN
TEL	06-6645-3905
Email	atamori@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Akihiro Middle name Last name Tamori
Organization	School of Medicine and Graduate school of Medicine Osaka City University
Division name	Department of Hepatology
Zip code	545-8585
Address	1-4-3, Asahimachi, Abeno, Osaka 545-8585, JAPAN
TEL	06-6645-3905
Homepage URL
Email	atamori@med.osaka-cu.ac.jp

Sponsor
Institute	School of Medicine and Graduate school of Medicine Osaka City University
Institute
Department

Funding Source
Organization	School of Medicine and Graduate school of Medicine Osaka City University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	School of Medicine and Graduate school of Medicine Osaka City University
Address	1-4-3, Asahimachi, Abeno, Osaka 545-8585, JAPAN
Tel	06-6645-3456
Email	ethics@med.osaka-cu.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	2020 Year 06 Month 01 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	Open public recruiting
Date of protocol fixation	2019 Year 01 Month 28 Day
Date of IRB	2019 Year 04 Month 25 Day
Anticipated trial start date	2019 Year 02 Month 01 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To confirm the efficacy and safety of patients who have received this treatment.

Management information
Registered date	2020 Year 06 Month 01 Day
Last modified on	2020 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046278

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.