UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Post marketing prospective study of daclatasvir and asunaprevir for hepatitis C virus genotype 1b infection
Title of the study (Brief title)	Post marketing prospective study of daclatasvir and asunaprevir
Region	Japan

Condition
Condition	hepatitis C virus infection
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To ecaluate safety, efficacy and factors influencing on treatment response of daclatasvir and asunaprevir on post marketing phase
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sustained virological response at 12 weeks after treatment
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	patients with genotype 1b hepatitis C virus infection
Key exclusion criteria	1)pregnant woman 2)decompensated cirrhosis
Target sample size	100

Research contact person
Name of lead principal investigator	Hideyuki Tamai
Organization	Wakayama Medical University
Division name	Second department of internal medicine
Address	811-1, Kimidera, Wakayama City
TEL	073-447-2300
Email	tamahide@wakayama-med.ac.jp

Public contact
Name of contact person	Hideyuki Tamai
Organization	Wakayama Medical University
Division name	Second department of internal medicine
Address	811-1, Kimidera, Wakayama City
TEL	073-447-2300
Homepage URL
Email	tamahide@wakayama-med.ac.jp

Sponsor
Institute	Second department of internal mediceine, Wakayama medical university
Institute
Department

Funding Source
Organization	Second department of internal mediceine, Wakayama medical university
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	2016 Year 07 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 22 Day
Anticipated trial start date	2014 Year 09 Month 22 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	Partially published
URL releasing results
Results
Other related information	During therapy, quantitative HCV-RNA, biochemical analyses including blood counts, serumalanine aminotransferase (ALT), aspartate aminotransferase (AST), liver functional tests, and renal functional test were performed every 4 weeks up to 12 weeks after the end of therapy.

Management information
Registered date	2016 Year 07 Month 21 Day
Last modified on	2017 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026812