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Recruitment status Completed
Unique ID issued by UMIN UMIN000014568
Receipt No. R000016754
Scientific Title Effectiveness and safety of simeprevir-basd triple therapy for chronic hepatitis C in multicenter study
Date of disclosure of the study information 2014/07/16
Last modified on 2016/01/22

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Basic information
Public title Effectiveness and safety of simeprevir-basd triple therapy for chronic hepatitis C in multicenter study
Acronym Effectiveness and safety of simeprevir-basd triple therapy
Scientific Title Effectiveness and safety of simeprevir-basd triple therapy for chronic hepatitis C in multicenter study
Scientific Title:Acronym Effectiveness and safety of simeprevir-basd triple therapy
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of simeprevir-based triple therapy (comparison with telaprevi-based triple therapy)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Sustained viral response (SVR)
Key secondary outcomes Factors associated with SVR
Adverse effects (anemia)
Efficacy and safety for older patients

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients infected with chronic hepatitis C virus genotype 1
Key exclusion criteria (1) positivity for antibody to human immunodeficiency virus or positivity for hepatitis B surface antigen
(2) clinical or biochemical evidence of hepatic decompensation (Child-Pugh B or C, ascites, bleeding varices, or encephalopathy);
(3) other causes of liver disease (hemochromatosis, autoimmune hepatitis, or primary biliary cirrhosis)
(4) excessive active alcohol consumption (a daily intake of more than 40g of ethanol), drug abuse or severe mental disorder
(5) the presence of active cancer at entry
(6) experienced treatment with telaprevir
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Furusyo
Organization The Kyushu Univerisity Liver Disease Study Group
Division name Department of General Internal Medicine, Kyushu University
Zip code
Address 3-1-1 Maidashi Higashi-ku, Fukuoka, 812-8582
TEL 092-642-5909
Email furusyo@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiichi Ogawa
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1 Maidashi Higashi-ku, Fukuoka, 812-8582
TEL 092-642-5909
Homepage URL
Email eogawa@gim.med.kyushu-u.ac.jp

Sponsor
Institute The Kyushu Univerisity Liver Disease Study Group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 07 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Simeprevir-based triple therapy have a lower risk of the development of severe anemia than telaprevir-based therapy. ITPA genotype and age are useful for individualizing treatment to reduce the risk of anemia-related adverse effects. 
Simeprevir-based triple therapy will continue to be a useful treatment option for treatment-naive or prior relapse patients with a favorable IL28B genotype (SVR>90%).
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 Completed
Date of protocol fixation
2013 Year 12 Month 01 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 Retrospective multicenter study

Management information
Registered date
2014 Year 07 Month 16 Day
Last modified on
2016 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016754


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