UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Drug Use-results Surveillance of SOVRIAD capsules100mg.
Title of the study (Brief title)	Drug Use-results Surveillance of SOVRIAD capsules100mg.
Region	Japan

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

Objectives
Narrative objectives1	To confirm the safety and efficacy of Sovriad Capsules in the patients with chronic hepatitis C.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety(Adverse Drug Reaction) Effectiveness(SVR12,SVR24)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with chronic hepatitis C who are treated with SOVRIAD capsules for the first time
Key exclusion criteria	NA
Target sample size	2200

Research contact person
Name of lead principal investigator	Toshiya Kato
Organization	Janssen Phrmaceutical K.K.
Division name	Safety Risk Management Dept.
Address	5-2,Nishi-Kanda 3-Chome, Chiyoda-ku, Tokyo
TEL	03-4411-5478
Email	tkato1@ITS.JNJ.com

Public contact
Name of contact person	Akiko Yamamoto
Organization	Janssen Phrmaceutical K.K.
Division name	Safety Risk Management Dept.
Address	5-2,Nishi-Kanda 3-Chome, Chiyoda-ku, Tokyo
TEL	03-4411-5173
Homepage URL
Email	ayamamot@its.jnj.com

Sponsor
Institute	Janssen Phrmaceutical K.K.
Institute
Department

Funding Source
Organization	Janssen Phrmaceutical K.K.
Organization
Division
Category of Funding Organization	Profit organization
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	2014 Year 12 Month 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 11 Month 07 Day
Anticipated trial start date	2013 Year 12 Month 18 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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospectives study

Management information
Registered date	2014 Year 12 Month 10 Day
Last modified on	2019 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018501