UMIN-CTR Clinical Trial

Basic information
Public title	A Study on Predictors of Treatment Response to Sofosbuvir and Ledipasvir Therapy in Patients with genotype 1 Chronic Hepatitis C Virus Infection
Acronym	Predictor of treatment response to SOF LDV therapy
Scientific Title	A Study on Predictors of Treatment Response to Sofosbuvir and Ledipasvir Therapy in Patients with genotype 1 Chronic Hepatitis C Virus Infection
Scientific Title:Acronym	Predictor of treatment response to SOF LDV therapy
Region	Japan

Condition
Condition	Patients with genotype 1 HCV infection
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of sofosbuvir plus ledipasvir therapy in patients with a chronic HCV genotype 1 infection, and investigate predictors of treatment response based on the analyses of viral and host factors
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To investigate the predictors obtained at baseline and affecting the sustained virologic response (SVR) rate/occurrence of adverse drug reactions at follow-up Week 12
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 (1) with the target disease who (2) satisfy all the inclusion criteria and (3) meet none of the exclusion criteria are eligible for the study. (1) Subjects Patients with a chronic HCV infection and compensated cirrhosis who are being treated as outpatients or inpatients at institutions participating in this study (2) Inclusion criteria [1] Patients who are 20 years of age or older at the time of informed consent [2] Patients who have been fully informed and have provided written informed consent to participate in this study prior to study initiation [3] Patients with a chronic HCV genotype 2 infection and compensated cirrhosis who do not meet any of the following exclusion criteria
Key exclusion criteria	1 Patients with poorly controlled cardiac disease (myocardial infarction, cardiac failure, arrhythmia) 2 Patients with severe hepatic impairment 3 Patients with a history of hypersensitivity to HCV NS5B inhibitors or Ribavirin 4 Patients with a concurrent malignancy, including hepatocellular carcinoma, at the start of treatment 5 Patients deemed unsuitable for study entry by their treating physician 6 Patients with renal dysfunction 7 Patients who are unsuitable, in the opinion of the principal investigator, for this study due to any other reason
Target sample size	260

Research contact person
Name of lead principal investigator	1st name Middle name Last name Goki Suda
Organization	Hokkaido University
Division name	Department of Gastroenterology and Hepatology, Graduate School of Medicine,
Zip code
Address	Kita 14-jo Nishi 5-jo, Kita-ku, Sapporo city, Hokkaid
TEL	+81-11-716-1161
Email	gsudgast@pop.med.hokudai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Goki Suda
Organization	Hokkaido University
Division name	Department of Gastroenterology and Hepatology, Graduate School of Medicine,
Zip code
Address	Kita 14-jo Nishi 5-jo, Kita-ku, Sapporo city, Hokkaido
TEL	+81-11-716-1161
Homepage URL
Email	gsudgast@pop.med.hokudai.ac.jp

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

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

JCHO Sapporo Hokushin Hospital Sapporo City General Hospital Abashiri-Kosei General Hospital Obihiro-Kosei General Hospital JCHO Hokkaido Hospital National Hospital Organization Hokkaido Medical 　Center　Hokkaido Gastroenterology Hospital Aiiku Hospital Sapporo Hokuyu Hospital Kushiro Rosai Hospital Hakodate Central General Hospital Hakodate Medical Association Hospital NTT EAST Sapporo Hospital Tomakomai City Hospital Japanese Red Cross Kitami Hospital Iwamizawa Municipal General Hospital Wakkanai City Hospital Tomakomai Nissho Hospital Sapporo Century Hospital Touei hospital Hakodate City General Hospital

Other administrative information
Date of disclosure of the study information	2015 Year 10 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	Completed
Date of protocol fixation	2015 Year 10 Month 01 Day
Date of IRB	2015 Year 10 Month 09 Day
Anticipated trial start date	2015 Year 10 Month 09 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This study is cohort study Way for subscription Patients who visit our hospital between October 2015 and march 2018, and meet inclusion criteria are enrolled. We will check below 1 Viral factors: HCV NS5A/NS3 inhibitor resistant mutations 2 Peripheral blood tests: WBC, differential WBC, Hb, and Plt 3 Liver function tests AST, ALT and ALP 4 Biochemistry LDH, BUN, total bilirubin, direct bilirubin, ALP, GTP, total protein, albumin, creatinine, Na, K, Cl, amylase, and lipase 5 Fibrosis markers: hyaluronic acid, type IV collagen etc, and AFP 6 Glucose tolerance tests fasting glucose, insulin, and HbA1c; Lipid metabolism: TC, LDL-C, and TG; Blood coagulation 7 Viral kinetics: serial measurement of viral load 8 Measurement of liver stiffness by liver biopsy FibroScan

Management information
Registered date	2015 Year 09 Month 14 Day
Last modified on	2022 Year 10 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021980