UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter phase II study assessed safety and efficacy of asunaprevir and daclatasvir in patients with chronic hepatitis C virus genotype 1 infection and end-stage renal disease requiring hemodialysis
Title of the study (Brief title)	A phase II study of asunaprevir and daclatasvir in patients requiring hemodialysis with chronic hepatitis C
Region	Japan

Condition
Condition	Chronic hepatitis C with end-stage renal disease requiring hemodialysis
Classification by specialty	Hepato-biliary-pancreatic medicine Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and safety of of asunaprevir and daclatasvir in patients with chronic hepatitis and end-stage renal disease requiring hemodialysis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sustained virological response at 12 weeks post-treatment.
Key secondary outcomes

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	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) Patients undergoing chronic hemodialysis. 2) Patients with chronic hepatitis or compensated cirrhosis infected with hepatitis C virus genotype 1.
Key exclusion criteria	1) Patients who have malignant neoplasm, including hepatocellular carcinoma. 2) Patients with decompensated cirrhosis.
Target sample size	25

Research contact person
Name of lead principal investigator	Iwata Ozaki
Organization	Saga University Hospital
Division name	Hepatology Division
Address	5-1-1 Nabeshima, Saga-Shi, Saga
TEL	0952-34-2362
Email	ozaki@cc.saga-u.ac.jp

Public contact
Name of contact person	Taiga Otsuka
Organization	Saga University Hospital
Division name	Hepatology Division
Address	5-1-1 Nabeshima, Saga-Shi, Saga
TEL	0952-34-2362
Homepage URL
Email	otsuka-t@umin.ac.jp

Sponsor
Institute	Saga Study Group of Liver Diseases
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	2014 Year 12 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 01 Day
Anticipated trial start date	2014 Year 12 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 09 Day
Last modified on	2017 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018485