UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of simeprevir with pegylated interferon alfa and low dose of ribavirin for patients with chronic hepatitis C genotype 1 and low hemoglobin level
Acronym	Efficacy and safety of simeprevir with pegylated interferon alfa and low dose of ribavirin
Scientific Title	Efficacy and safety of simeprevir with pegylated interferon alfa and low dose of ribavirin for patients with chronic hepatitis C genotype 1 and low hemoglobin level
Scientific Title:Acronym	Efficacy and safety of simeprevir with pegylated interferon alfa and low dose of ribavirin
Region	Japan

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

Objectives
Narrative objectives1	To assessment of efficacy and safety of simeprevir with pegylated interferon and low dose of ribavirin in patients with chronic hepatits C and low hemoglobin level. To investigate the relative factor with antiviral effect, emergence of drug-resistant virus and the suppressive effect for incidence of hepatocellular carcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sustained virologic response rate
Key secondary outcomes	The factor associated with sustained virologic response Safety Emergence of drug-resistant virus Cumulative incidence of hepatocellular carcinoma The factor associated with incidence of hepatocellular carcinoma

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 with pegylated interferon alfa and low dose of ribavirin Simeprevir: 100mg/day, orally, 12 weeks Pegylated interferon: alfa-2a 180mcg/week, alfa-2b 1.5mcg/kg/week, subcutaneous infusion, 24 weeks Ribavirin: If hemoglobin is between 10g/dl and 12g/dl, ribavirin 400mg/day, orally, 24 weeks. If hemoglobin is between 8.5g/dl and 10g/dl, ribavirin 200mg/day, orally, 24 weeks. Simeprevir, Pegylated interferon plus ribavirin 12 weeks and following Pegylated interferon plus ribavirin 12 weeks, total 24 weeks treatement
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) Patients with 20 years of age and older 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) Patients with less than 12 g/dl of hemoglobin 5) Eligible patients for interferon and ribavirin 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) Severe multisystem disease, Severe immunodeficiency 6) Contraindication to pegylated interferon 7) Contraindication to ribabirin
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) Severe multisystem disease, Severe immunodeficiency 6) Contraindication to pegylated interferon 7) Contraindication to ribabirin
Target sample size	55

Research contact person
Name of lead principal investigator	1st name Tetsuo Middle name Last name Takehara
Organization	Osaka University Graduate School of Medicine
Division name	Gastroenterology and Hepatology
Zip code	565-0871
Address	2-2, Yamadaoka, Suita, Osaka, Japan
TEL	81-6-6879-3621
Email	takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Ryotaro Middle name Last name Sakamori
Organization	Osaka University Graduate School of Medicine
Division name	Gastroenterology and Hepatology
Zip code	565-0871
Address	2-2, Yamadaoka, Suita, Osaka, Japan
TEL	81-6-6879-3621
Homepage URL
Email	sakamori@gh.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	Grant-in-aid from Japan Agency fir Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Janssen Pharmaceutical K.K.

IRB Contact (For public release)
Organization	Osaka University Clinical Research Review Committee
Address	2-2, Yamadaoka, Suita, Osaka
Tel	06-6210-8289
Email	rinri@hp-crc.med.osaka-u.ac.jp

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	2015 Year 07 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Preinitiation
Date of protocol fixation	2014 Year 11 Month 13 Day
Date of IRB
Anticipated trial start date	2014 Year 11 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 07 Month 29 Day
Last modified on	2019 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021395

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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