UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023267
Receipt No. R000026812
Scientific Title Post marketing prospective study of daclatasvir and asunaprevir for hepatitis C virus genotype 1b infection
Date of disclosure of the study information 2016/07/21
Last modified on 2017/07/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Post marketing prospective study of daclatasvir and asunaprevir for hepatitis C virus genotype 1b infection
Acronym Post marketing prospective study of daclatasvir and asunaprevir
Scientific Title Post marketing prospective study of daclatasvir and asunaprevir for hepatitis C virus genotype 1b infection
Scientific Title:Acronym 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
1st name
Middle name
Last name Hideyuki Tamai
Organization Wakayama Medical University
Division name Second department of internal medicine
Zip code
Address 811-1, Kimidera, Wakayama City
TEL 073-447-2300
Email tamahide@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideyuki Tamai
Organization Wakayama Medical University
Division name Second department of internal medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 09 Month 22 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000026812

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.