UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Telaprevir therapy in Japanese patients infected with HCV
Title of the study (Brief title)	Teraprevir in Japanese CH-C
Region	Japan

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

Objectives
Narrative objectives1	To examine the safety and efficacy in Telaprevir therapy in Japanese patients infected with hepatitis C virus (HCV)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Anti-viral effects against HCV
Key secondary outcomes	1) Association between IL28SNP and treatment response 2) Treatment response and HCV RNA dynamics 3) HCV genome and treatment response

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	HCV genotype 1 (subtype 1a or 1b) infected patients
Key exclusion criteria	1) Hemoglobin <12g/dl, Neutrophil < 1500/mm3, or Platelet count <100000/mm3 2) Drug allergy to telaprevir, interferon, ribavirin or nucleoside analogues 3) Past-history of dermatological reaction of teraprevir 4) Pregnant women, etc. 5) Women cannot prevent conception. 6) Men cannot prevent conception. 7) Severe heart diseases 8) Abnormal hemoglobinemia 9) Severe renal dysfunction 10) Uncontrolable mental illness 11) Severe liver diseases 12) Uncontrolable autoimmune diseases 13) Past-history of hypersensitivity against vaccination, etc. 14) Patients take prohibited drugs, which interacts with telaprevir. 15) Doctors judged patients as inappropriate persons in this trial
Target sample size	200

Research contact person
Name of lead principal investigator	Osamu Yokosuka, M.D.
Organization	Chiba University, Graduate School of Medicine
Division name	Department of Gastroenterology and Nephrology
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan (260-8677)
TEL	+81-43-226-2083
Email	kandat-cib@umin.ac.jp

Public contact
Name of contact person	Tatsuo Kanda, M.D.
Organization	Chiba University, Graduate School of Medicine
Division name	Department of Gastroenterology and Nephrology
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan (260-8677)
TEL	+81-43-226-2083
Homepage URL
Email	kandat-cib@umin.ac.jp

Sponsor
Institute	Chiba University, Graduate School of Medicine
Institute
Department

Funding Source
Organization	Chiba University, Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
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	Chiba University Hospital (Chiba, JPN), Kikkoman General Hospital (Chiba, JPN) 千葉大学医学部附属病院(千葉県)、キッコーマン総合病院(千葉県)

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 08 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 03 Month 24 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date	2014 Year 04 Month 30 Day
Date of closure to data entry	2014 Year 04 Month 30 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	In future, we will perform the observation study.

Management information
Registered date	2012 Year 05 Month 08 Day
Last modified on	2017 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009320