UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of simeprevir with pegylated interferon alfa-2b and ribavirin in kidney transplant patients with chronic hepatitis C
Title of the study (Brief title)	Efficacy and safety of simeprevir with pegylated interferon alfa-2b and ribavirin in kidney transplant patients with chronic hepatitis C
Region	Japan

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

Objectives
Narrative objectives1	To assess efficacy and safety of simeprevir with pegylated interferon and ribavirin in kidney transplant patients with chronic hepatits C.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sustained virologic response rate 12(SVR12)
Key secondary outcomes

Base
Study type

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Simeprevir with pegylated interferon alfa and ribavirin
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients with 20-70 years of age 2) Naive patients with HCV egnotype 1 with viral load of more than 5 log IU/ml 3) Treatment-experienced patients with HCV egnotype 1 4) Eligible patients for interferon and ribavirin
Key exclusion criteria	1) Co-infection with hepatitis B virus 2) Co-infection with anti-human immunodeficiency virus 3) Other forms of liver disease (alcohol liver disease, autoimmune hepatitis etc.) 4) Decompensated cirrhosis, Liver failure 5) Contraindication to pegylated interferon 6) Contraindication to ribavirin
Target sample size	18

Research contact person
Name of lead principal investigator	Shiro Takahara
Organization	Osaka University Graduate School of Medicine
Division name	Department of Advanced Technology for Transplantation
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3746
Email	takahara@att.med.osaka-u.ac.jp

Public contact
Name of contact person	Naotsugu Ichimaru
Organization	Osaka University Graduate School of Medicine
Division name	Department of Advanced Technology for Transplantation
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3746
Homepage URL
Email	ichimaru@att.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Janssen Pharmaceutical
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 02 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 06 Day
Anticipated trial start date	2014 Year 02 Month 06 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 02 Month 06 Day
Last modified on	2019 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015271