UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of Ledipasvir/Sofosbuvir in chronic hepatitis C of Genotype1b with chronic kidney disease(eGFR30-60ml/min/1.73m2)
Acronym	Efficacy and safety of Ledipasvir/Sofosbuvir in patient with chronic kidney disease
Scientific Title	Efficacy and safety of Ledipasvir/Sofosbuvir in chronic hepatitis C of Genotype1b with chronic kidney disease(eGFR30-60ml/min/1.73m2)
Scientific Title:Acronym	Efficacy and safety of Ledipasvir/Sofosbuvir in patient with chronic kidney disease
Region	Japan

Condition
Condition	Chronic hepatitis C
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the efficacy and safety of Ledipasvir and Sofosbuvir combination therapy for genotype1b-infected chronic hepatitis C patients with chronic kidney disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Sustained virological response rate
Key secondary outcomes	1. Change in serum HCV RNA during treatment and follow-up duration 2. Change in hematological and biochemical test during treatment and follow-up duration 3.Change of renal function during a treatment period 4. Frequency of a side effect during a treatment period 5. Change in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients were treated with Ledipasvir and Sofosbuvir combination therapy
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	18 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with chronic hepatitis C who treat with Ledipasvir/Sofosbuvir combination therapy.
Key exclusion criteria	1.History of allergy to Ledipasvir and Sofosbuvir. 2.Decompensated liver cirrhosis 3.pregnant woman or lactating mother 4.Hepatocellular carcinoma, or other malignant tumor. 5.severe depression 6.Judged by investigator not to be appropriate for inclusion in this study 7.Patient with dialysis or patients with severe renal function disorder (eGFR<30ml/min/1.73m2) 8.Receiving contraindicated drugs for Ledipasvir and Sofosbuvir combined therapy
Target sample size	700

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masanori Atsukawa
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Gastroenterology
Zip code
Address	1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL	0476-99-1111
Email	atsukawa-nms@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masanori Atsukawwa
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Gastroenterology
Zip code
Address	1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL	0476-99-1111
Homepage URL
Email	atsukawa-nms@umin.ac.jp

Sponsor
Institute	Nippon Medical School Chiba Hokusoh Hospital
Institute
Department

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

Other related organizations
Co-sponsor	Nippon Medical School Hospital Nippon Medical School Musashi Kosugi Hospital The Jikei University Hospital Otakanomori Hospital Hakujikai Healthcare foundation Tokyo Metropolitan Bokutoh Hospital Tokyo Medical University Ibaraki Medical Center Shinmatsudo Central General Hospital Japanese Red Cross Narita Hospital
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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 21 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 09 Month 01 Day
Date of IRB	2015 Year 09 Month 15 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date	2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 21 Day
Last modified on	2020 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031904