UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of simeprevir plus pegylated intereferon combination therapy for HCV genotype 1 patients with chronic renal failure
Title of the study (Brief title)	Simeprevir plus pegylated intereferon combination therapy for HCV genotype 1 patients with chronic renal failure
Region	Japan

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

Objectives
Narrative objectives1	Investigating sustained virological response rate (the rate of undetectable HCV RNA at end of treatment and at 24 weeks after completion of treatment) of Simeprevir plus Peg-IFN combination therapy in HCV genotype 1 patients with chronic renal failure.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	- Investigating sustained virological response rate (the rate of undetectable HCV RNA at end of treatment and at 24 weeks after completion of treatment) of Simeprevir plus Peg-IFN combination therapy in HCV genotype 1 patients with chronic renal failure. - Investigating the factors for sustained virological response.
Key secondary outcomes

Base
Study type	Interventional

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 plus Peg-IFN combination therapy
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	1) Hemodialysis patients 2) Patients with chronic infection with hepatitis C virus genotype 1 and more than 5 log IU/ml
Key exclusion criteria	1) Patients with co-infection with hepatitis B virus or human immunodeficiency virus or alcoholic liver disorder or autoimmune hepatitis. 2) Patients with uncompensated cirrhosis or hepatic failure 3) Patients with multiple organ failure or immunological deficiency 4) Patients with severe depression or past history of psychiatric disorder 5) Patients in pregnancy or lactating or patients who expect to become pregnant
Target sample size	45

Research contact person
Name of lead principal investigator	Tetsuo Takehara
Organization	Osaka University Graduate school of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	Yamadaoka 2-2, Suita, Osaka, Japan
TEL	06-6879-3621
Email	takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person	Naoki Hiramatsu
Organization	Osaka University Graduate school of Medicine
Division name	Gastroenterology and Hepatology
Address	Yamadaoka 2-2, Suita, Osaka, Japan
TEL	06-6879-3621
Homepage URL
Email	hiramatsu@gh.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate school of Medicine
Institute
Department

Funding Source
Organization	Osaka University Graduate school of Medicine
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	2013 Year 12 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 05 Day
Anticipated trial start date	2013 Year 12 Month 25 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	2013 Year 12 Month 24 Day
Last modified on	2017 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014812