UMIN-CTR Clinical Trial

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

Condition
Condition	hemodialyzed patients with genotype 1 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 Daclatasvir and Asunaprevir 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	Others,meta-analysis etc

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 dacalatasvir and asunaprevir between November 2014 and march 2016
Key exclusion criteria	1patients with heart failure 2patients with decompensated cirrhosis 3patients with allergic to NS5A inhibitor or HCV PI inhibitor 4 patients with HCC or other malignant disease
Target sample size	130

Research contact person
Name of lead principal investigator	1st name Goki Middle name Last name Suda
Organization	Graduate School of Medicine,Hokkaido University
Division name	Department of Gastroenterology and Hepatology, Graduate School of Medicine
Zip code	065-0010
Address	Kita 14-jo Nishi 5-jo, Kita-ku, Sapporo city, Hokkaid
TEL	011-716-1161
Email	gsudgast@pop.med.hokudai.ac.jp

Public contact
Name of contact person	1st name Goki Middle name Last name Suda
Organization	Hokkaido University
Division name	Department of Gastroenterology and Hepatology, Graduate School of Medicine,
Zip code	065-0010
Address	Kita 14-jo Nishi 5-jo, Kita-ku, Sapporo city, Hokkaid
TEL	011-716-1161
Homepage URL
Email	gsudgast@pop.med.hokudai.ac.jp

Sponsor
Institute	others
Institute
Department

Funding Source
Organization	self funding
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	IRB committee of Hokkaido University Hospital
Address	Sapporo city kita ku kita14zyou nishi 5
Tel	0117067061
Email	crjimu@huhp.hokudai.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	2016 Year 09 Month 29 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 29 Day
Date of IRB	2016 Year 09 Month 29 Day
Anticipated trial start date	2016 Year 09 Month 29 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Safety and efficacy of Daclatasvir and Asunaprevir combination therapy Observation and Test Parameters and Methods The following items will be checked. Patient characteristics: gender, age, height, liver histology, prior treatments, allergic history, medical history, and any complications Hematological parameters 1Viral factors: HCV NS5A/NS3 inhibitor resistant mutations 2Peripheral blood tests: WBC, differential WBC, Hb, and Plt 3Liver function tests: AST, ALT, GTP, and ALP 4Biochemistry: LDH, BUN, total bilirubin, direct bilirubin, ALP, total protein, albumin, creatinine, Na, K, Cl, amylase, and lipase 5Fibrosis markers: hyaluronic acid, type IV collagen, and AFP 6Glucose tolerance tests:fasting glucose, insulin, and HbA1c; Lipid metabolism: TC, LDL-C, and TG; Blood coagulation: PT-INR 7Viral kinetics: serial measurement of viral load (Taqman-PCR assay) 8IL28B, 9Measurement of liver stiffness by liver biopsy/FibroScan

Management information
Registered date	2016 Year 09 Month 29 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=R000027897