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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012183
Receipt No. R000014241
Scientific Title Efficacy and safety of simeprevir with pegylated interferon alfa and ribavirin in patients with chronic hepatitis C
Date of disclosure of the study information 2013/11/01
Last modified on 2019/08/02

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Basic information
Public title Efficacy and safety of simeprevir with pegylated interferon alfa and ribavirin in patients with chronic hepatitis C
Acronym Efficacy and safety of simeprevir with pegylated interferon alfa and ribavirin
Scientific Title Efficacy and safety of simeprevir with pegylated interferon alfa and ribavirin in patients with chronic hepatitis C
Scientific Title:Acronym Efficacy and safety of simeprevir with pegylated interferon alfa and 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 ribavirin in patients with chronic hepatits C.
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
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
Key secondary outcomes

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
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

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) 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) Severe multisystem disease, Severe immunodeficiency
6) Contraindication to pegylated interferon
7) Contraindication to ribabirin
Target sample size 500

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 for Research on Hepatitis from Ministry of Health Labour and Welfare of Japan, and Scientific Research from the Ministry of Education, Science, and Culture of Japan
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2013 Year 11 Month 01 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
2013 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 01 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
2013 Year 10 Month 31 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=R000014241

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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