UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Predictive factors associated with virological response in Daclatasvir and Asunaprevir combination therapy for genotype1b-infected chronic hepatitis C patients : multicenter study
Title of the study (Brief title)	Predictive factors for virological response in Daclatasvir and Asunaprevir combination therapy
Region	Japan

Condition
Condition	Chronic hepatitis C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To confirm the Predictive factors associated with virological response in Daclatasvir and Asunaprevir combination therapy for genotype1b-infected chronic hepatitis C patients.
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 rate
Key secondary outcomes	1. Change in serum HCV RNA during treatment and follow-up duration 2. Change in hematological and biochemical test during treatment and follow-up duration 3. Change in beta-hydroxycholesterol during treatment and follow-up duration 4. Safety and efficacy of treatment for patients with renal insufficiency or renal failure including hemodyalysis 5. Change in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration.

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	Patients were treated with Daclatasvir and Asunaprevir combination therapy
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	18 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with chronic hepatitis C who treat with Daclatasvir/Asunaprevir combination therapy.
Key exclusion criteria	1.History of allergy to Daclatasvir, and Asunaprevir. 2.Decompensated liver cirrhosis 3.pregnant woman or lactating mother 4.Hepatocellular carcinoma, or other malignant tumor. 5.severe depression 6.Judged by investigator not to be appropriate for inclusion in this study
Target sample size	300

Research contact person
Name of lead principal investigator	Masanori Atsukawa
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Gastroenterology
Address	1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL	0476-99-1111
Email	atsukawa-nms@umin.ac.jp

Public contact
Name of contact person	Masanori Atsukawa
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Gastroenterology
Address	1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL	0476-99-1111
Homepage URL
Email	atsukawa-nms@umin.ac.jp

Sponsor
Institute	Nippon Medical School Chiba Hokusoh Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

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	日本医科大学付属病院(東京都)、東京慈恵会医科大学付属柏病院（千葉県）、東京慈恵会医科大学葛飾医療センター（東京都）、千葉徳洲会病院（千葉県）、博慈会記念病院（東京都）、東京都立墨東病院（東京都）、町田市民病院（東京都）、茨城県立中央病院・茨城地域がんセンター（茨城県）、東京医科大学茨城医療センター（茨城県）、我孫子聖仁会病院（千葉県）

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 17 Day
Anticipated trial start date	2015 Year 04 Month 17 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
Other related information

Management information
Registered date	2015 Year 04 Month 16 Day
Last modified on	2017 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019893