UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of Grazoprevir and Elbasvir combination therapy for hemodialyzed patients with genotype 1 chronic hepatitis C infection
Acronym	Grazoprevir/Elbasvir therapy for hemodialyzed patients
Scientific Title	Safety and efficacy of Grazoprevir and Elbasvir combination therapy for hemodialyzed patients with genotype 1 chronic hepatitis C infection
Scientific Title:Acronym	Grazoprevir/Elbasvir therapy for hemodialyzed patients
Region	Japan

Condition
Condition	hemodialyzed patients with chronic hepatitis C infection
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analyze Safety and efficacy of Grazoprevir/Elbasvir combination therapy for hemodialyzed patients with chronic hepatitis C infection
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sustained virological response adverse events
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	hemodialyzed patients with genotype 1 chronic hepatitis C, who initiated on Grazoprevir/Elbasvir and asunaprevir between January 2017 and march 2019
Key exclusion criteria	1 Patients with a past history of hypersensitivity to HCV protease inhibitors and NS5A inhibitors 2 Patients with serious liver dysfunction (Child-Pugh Class B or C) 3 Patients with difficult-to-control heart disease (e.g., myocardial infarction, heart failure, and arrhythmia) 4 Patients who have malignant tumors, including hepatoma, at the start of treatment 5 Patients on treatment with drugs listed in the contraindications for coadministration in the package insert (e.g., some antifungals, some antiepileptics, and human immunodeficiency virus (HIV) protease inhibitors) 6 Patients with albumin <3.0 g/dL 7 Other patients judged to be inappropriate to participate in the study by the primary physician
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Goki Suda
Organization	Graduate School of Medicine, Hokkaido University
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL	011-716-2111
Email	gsudgast@pop.med.hokudai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Goki Suda
Organization	Graduate School of Medicine, Hokkaido University
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL	011-716-2111
Homepage URL
Email	gsudgast@pop.med.hokudai.ac.jp

Sponsor
Institute	Graduate School of Medicine, Hokkaido University
Institute
Department

Funding Source
Organization	MSD K.K
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2017 Year 01 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	2016 Year 09 Month 01 Day
Date of IRB	2017 Year 01 Month 21 Day
Anticipated trial start date	2017 Year 01 Month 21 Day
Last follow-up date	2020 Year 01 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

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, GTP, 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 collagen, 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 IL28B 9 Measurement of liver stiffness by liver biopsy/FibroScan

Management information
Registered date	2017 Year 01 Month 21 Day
Last modified on	2020 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029655