UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016205 |
|---|---|
| Receipt number | 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 13:27:56 |
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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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018804
