UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness and safety of daclatasvir plus asunaprevir for chronic HCV genotype 1 infection
Title of the study (Brief title)	Effectiveness and safety of daclatasvir plus asunaprevir
Region	Japan

Condition
Condition	Chronic HCV genotype 1b infection
Classification by specialty	Hepato-biliary-pancreatic medicine Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this prospective study is to evaluate the virological efficacy and safety of daclatasvir plus asunaprevir.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Sustained virological response (SVR)
Key secondary outcomes	1. Efficacy and safety for patients with older or CKD (HD) 2. Predictive factor of SVR 3. Evaluation of adverse effects 4. Relationship between treatment outcome and HCV resistance-associated substitutions to daclatasvir

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	24-week course of daclatasvir (Daklinza; Bristol-Myers Squibb, Tokyo, Japan) (60 mg tablet once daily) and asunaprevir (Sunvepra; Bristol-Myers) (100 mg softgel capsule twice daily)
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Ineligible/Intolerance for interferon-based therapy 2. Non-virological response for the past interferon-based treatment 3. This study will be explained and informed consent needs to be obtained from all the patients.
Key exclusion criteria	1. Decompensated cirrhosis (Child B or C) 2. ALT level of more than five times the upper limit of normal range 3. Severe kidney damage (eGFR<30) 4. Coinfection with HBV or HIV 5. Women with pregnancy or breast feeding 6. Patients using contraindication drugs
Target sample size	400

Research contact person
Name of lead principal investigator	Norihiro Furusyo
Organization	Kyushu University Hospital
Division name	Department of General Internal Medicine
Address	3-1-1 Maidashi Higashi-ku, Fukuoka
TEL	+81926425909
Email	furusyo@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person	Eiichi Ogawa
Organization	Kyushu University Hospital
Division name	Department of General Internal Medicine
Address	3-1-1 Maidashi Higashi-ku, Fukuoka
TEL	+81926425909
Homepage URL
Email	eogawa@gim.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University 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	九州大学関連肝疾患治療研究会（KULDS）

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 06 Day
Anticipated trial start date	2014 Year 11 Month 06 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	Published
URL releasing results
Results	* Daclatasvir plus asunaprevir for HCV genotype 1b was well tolerated and effective for patients without pre-existent NS5A RAVs or simeprevir failure, irrespective of fibrosis status.
Other related information

Management information
Registered date	2014 Year 11 Month 07 Day
Last modified on	2017 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018162