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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018971
Receipt No. 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

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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
Email 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
Email kazuh@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya university
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021952

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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