UMIN-CTR Clinical Trial

Basic information
Public title	Effect and adverse effect of direct acting antivirals for the patients with HCV
Acronym	Effect and adverse effect of direct acting antivirals for the patients with HCV
Scientific Title	Effect and adverse effect of direct acting antivirals
Scientific Title:Acronym	Effect and adverse effect of direct acting antivirals
Region	Japan

Condition
Condition	Chronic hepatitis, type C, Liver cirrhosis, type C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to examine the efficacy and the frequencies of adverse effect in the patients with HCV receiving direct acting antivirals therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sustained virological response
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	Administration of DAAs
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. more than 20 years old 2. patient with genotype 1b HCV 3. over 50,000/ micro litter of platelet 4. the patient received curative HCC treatment (if experienced HCC) 5. the patient received explanation and consent 6. HCV RNA positive (if treatment naive patient)
Key exclusion criteria	1. the female patient in pregnancy or breast-feeding 2. the patient experienced allergic reaction for daclatasvir and or asunaprevir 3. the liver cirrhosis patient with over Child-pugh score 7 4. the patient whose blood examination data was below the standard value 5. the patient the investigator judged unsuitable for study
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Kazuhiko Middle name Last name Nakao
Organization	Nagasaki university hospital
Division name	Department of gastroenterology and hepatology
Zip code	852-8501
Address	Sakamoto 1-7-1, Nagasaki city
TEL	0958197481
Email	kazuhiko@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Naota Middle name Last name Taura
Organization	Nagasaki university hospital
Division name	Department of gastroenterology and hepatology
Zip code	8528117
Address	Sakamoto 1-7-1, Nagasaki city
TEL	0958197481
Homepage URL
Email	ntaura-g@nagasaki-u.ac.jp

Sponsor
Institute	Department of gastroenterology and hepatology, Nagasaki university hospital
Institute
Department

Funding Source
Organization	Department of gastroenterology and hepatology, Nagasaki university hospital
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	Clinincal research center, Nagasaki university hospital
Address	1-7-1 Sakamoto
Tel	0958197726
Email	samamoto@nagasaki-u.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	2021 Year 05 Month 18 Day

Related information
URL releasing protocol	The study was aborted.
Publication of results	Unpublished

Result
URL related to results and publications	The study was aborted.
Number of participants that the trial has enrolled	0
Results	Although a research design was planed, the study was aborted.
Results date posted	2021 Year 05 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	No participant
Participant flow	No participant
Adverse events	None (No participant)
Outcome measures	The study was aborted.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 09 Month 02 Day
Date of IRB	2014 Year 09 Month 02 Day
Anticipated trial start date	2017 Year 12 Month 31 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 17 Day
Last modified on	2021 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050518