UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of daclatasvir and asunaprevir in chronic hepatitis C patients with hemodialysis
Title of the study (Brief title)	Efficacy of daclatasvir and asunaprevir in chronic hepatitis C patients with hemodialysis
Region	Japan

Condition
Condition	Chronic hepatitis C with hemodialysis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assessment of efficacy and safety of daclatasvir and asunaprevir in chronic hepatits C patients with hemodialysis .
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	Sustained virologic response rate at 24 weeks post-treatment
Key secondary outcomes	Safety The factor associated with sustained virologic response Emergence of drug-resistant virus Cumulative incidence of hepatocellular carcinoma

Base
Study type

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	Asunaprevir 200mg twice daily and daclatasvir 60mg once daily for 24 weeks.
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) Chronic hepatitis or cirrhosis patients with HCV genotype 1 (2) Patients with hemodialysis (3) Patients with 20 years of age and older
Key exclusion criteria	(1) Decompensated cirrhosis, Liver failure (2)patients with hepatic cell carcinoma (3) Co-infection with hepatitis B virus Co-infection with anti- humanimmunodeficiency virus
Target sample size	30

Research contact person
Name of lead principal investigator	uojima haruki
Organization	shonan kamakura general hospital
Division name	department of gastroenterology
Address	1370-1 okamoto,kamakura, kanagawa, japan
TEL	0467-46-1717
Email	kiruha555@yahoo.co.jp

Public contact
Name of contact person	uojima haruki
Organization	shonan kamakura general hospital
Division name	department of gastroenterology
Address	1370-1 o,kamakura, kanagawa, japan
TEL	0467-46-1717
Homepage URL
Email	kiruha555@yahoo.co.jp

Sponsor
Institute	shonan kamakura general hospital
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)

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 01 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 22 Day
Anticipated trial start date	2015 Year 01 Month 14 Day
Last follow-up date	2016 Year 08 Month 28 Day
Date of closure to data entry	2016 Year 08 Month 28 Day
Date trial data considered complete	2016 Year 08 Month 31 Day
Date analysis concluded	2016 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	none

Management information
Registered date	2015 Year 01 Month 12 Day
Last modified on	2016 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018783