UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014568 |
|---|---|
| Receipt number | 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 20:45:15 |
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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
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
| 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
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
eogawa@gim.med.kyushu-u.ac.jp
Sponsor or person
Institute
The Kyushu Univerisity Liver Disease Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016754
