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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016205
Receipt No. R000018804
Scientific Title Effectiveness of simeprevir-based triple therapy for patients with telaprevir failure
Date of disclosure of the study information 2015/01/13
Last modified on 2015/07/13

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Basic information
Public title Effectiveness of simeprevir-based triple therapy for patients with telaprevir failure
Acronym Effectiveness of simeprevir for patients with telaprevir failure
Scientific Title Effectiveness of simeprevir-based triple therapy for patients with telaprevir failure
Scientific Title:Acronym Effectiveness of simeprevir for patients with telaprevir failure
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 of simeprevir-based triple therapy for patients with telaprevir failure
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Sustained virological response (SVR)
Key secondary outcomes 1. Predictors associated with SVR
2. Safety of simeprevir-based triple therapy
3. Association between HCV variants and efficacy

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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients infected with chronic hepatitis C virus genotype 1
2. Telaprevir-experienced patients
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
Target sample size 30

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

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
2015 Year 01 Month 13 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
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
2014 Year 07 Month 13 Day

Other
Other related information Multicenter obsevational study

Management information
Registered date
2015 Year 01 Month 13 Day
Last modified on
2015 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018804

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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