UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018971 |
|---|---|
| Receipt number | R000021952 |
| Scientific Title | The combination therapy of PEG-IFN alpha 2b, Ribavirin and Telaprevir for the patients with chronic hepatitis C:the study for treatment duration by response guided therapy and prediction of efficacy by gene analysis in Japan. |
| Date of disclosure of the study information | 2015/10/02 |
| Last modified on | 2015/10/02 15:53:46 |
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Basic information
Public title
The combination therapy of PEG-IFN alpha 2b, Ribavirin and Telaprevir for the patients with chronic hepatitis C:the study for treatment duration by response guided therapy and prediction of efficacy by gene analysis in Japan.
Acronym
The response guided therapy of PEG-IFN alpha 2b, Ribavirin and Telaprevir for the patients with chronic hepatitis C
Scientific Title
The combination therapy of PEG-IFN alpha 2b, Ribavirin and Telaprevir for the patients with chronic hepatitis C:the study for treatment duration by response guided therapy and prediction of efficacy by gene analysis in Japan.
Scientific Title:Acronym
The response guided therapy of PEG-IFN alpha 2b, Ribavirin and Telaprevir for the patients with chronic hepatitis C
Region
| Japan |
Condition
Condition
chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluated the effect of The combination therapy of PEG-IFN alpha 2b, Ribavirin and Telaprevir for the patients with chronic hepatitis C using by the study for treatment duration by response guided therapy and prediction of efficacy by gene analysis in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SVR rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Seiection according to Rapid Virological Response
Interventions/Control_2
treatment trem
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
chronic hepatitis C genotype1b and high viral load (Real time PCR; over 5.0Log IU/mL)
Key exclusion criteria
1. patients contraindication for telaprevir
2) patients with rush by telaprevir
3) patients who used contraindication drugs with telaprevir
4) pregnacy
5) pregnacy for partener
6) partner can not understand contraception
7) allergy for RBV
8) sevre heart disease
9) salasemia
10) sevre renal disease
11) mental desease
12) sevre liver disease
13) AIH
14) contraindication for PEG-IFN-2b
15) allergy for vaccine
16) shosaikoto user
17) plick test positive
18)
a. Hb>12g/dl
b. nuet>1,500/mm3
c. platetlet>100,000/mm3
19) past use of telaprevir
20) active infecious desisease
21) cancer
22) contraindication by doctor in charge
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidemi goto |
Organization
Nagoya university
Division name
Gastroenterolgy and Hepatology
Zip code
Address
65 tsuruma Showa Nagoya Aichi
TEL
052-741-2111
hgoto@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Hayashi |
Organization
Nagoya university
Division name
Gastroenterolgy and Hepatology
Zip code
Address
65 tsuruma Showa Nagoya Aichi
TEL
052-741-2111
Homepage URL
kazuh@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
Funding Source
Organization
Nagoya university
Organization
Division
Category of Funding Organization
Self funding
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 | 10 | Month | 02 | 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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 21 | 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
| 2015 | Year | 09 | Month | 10 | Day |
Last modified on
| 2015 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021952
