UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of ledipasvir and sofosbuvir in patients with chronic hepatitis C
Acronym	Efficacy and safety of ledipasvir and sofosbuvir
Scientific Title	Efficacy and safety of ledipasvir and sofosbuvir in patients with chronic hepatitis C
Scientific Title:Acronym	Efficacy and safety of ledipasvir and sofosbuvir
Region	Japan

Condition
Condition	Patients with chronic hepatitis C virus infection
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assessment of efficacy and safety of ledipasvir and sofosbuvir in patients with chronic hepatits C. To investigate the relative factor with antiviral effect, emergence of drug-resistant virus and the suppressive effect for incidence of hepatocellular carcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sustained virologic response rate Safety Cumulative incidence of hepatocellular carcinoma
Key secondary outcomes	The factor associated with sustained virologic response Emergence of drug-resistant virus The factor associated with incidence of hepatocellular carcinoma

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	1) Patients with 20 years of age and older 2) Chronic hepatitis or compensated cirrhosis patients with HCV serogroup 1 3) Eligible patients for ledipasvir and sofosbuvir
Key exclusion criteria	1) Severe multisystem disease, Severe immnodeficiency 2) Patients with chronic renal failure or patients with hemodialysis 3) Contraindication to ledipasvir or sofosbuvir 4) Contraindication to ledipasvir and sofosbuvir
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Tetsuo Middle name Last name Takehara
Organization	Osaka University Graduate School of Medicine
Division name	Gastroenterology and Hepatology
Zip code	565-0871
Address	2-2, Yamadaoka, Suita, Osaka, Japan
TEL	81-6-6879-3621
Email	takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Ryotaro Middle name Last name Sakamori
Organization	Osaka University Graduate School of Medicine
Division name	Gastroenterology and Hepatology
Zip code	565-0871
Address	2-2, Yamadaoka, Suita, Osaka, Japan
TEL	81-6-6879-3621
Homepage URL
Email	sakamori@gh.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	Grant-in-aid from Japan Agency fir Medical Research and Development
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	Osaka University Clinical Research Review Committee
Address	2-2, Yamadaoka, Suita, Osaka
Tel	06-6210-8289
Email	rinri@hp-crc.med.osaka-u.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 08 Month 06 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	Preinitiation
Date of protocol fixation	2015 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To assessment of efficacy and safety of ledipasvir and sofosbuvir in patients with chronic hepatits C. To investigate the relative factor with antiviral effect, emergence of drug-resistant virus and the suppressive effect for incidence of hepatocellular carcinoma.

Management information
Registered date	2015 Year 08 Month 06 Day
Last modified on	2019 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021480