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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010587
Receipt No. R000012365
Scientific Title Comprehensive and individualized trial of teraprevir/peginterferon alpha-2b/ribavirin for chronic hepatitis C patients with genotype 1 and high viral loads
Date of disclosure of the study information 2013/05/01
Last modified on 2015/08/30

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Basic information
Public title Comprehensive and individualized trial of teraprevir/peginterferon alpha-2b/ribavirin for chronic hepatitis C patients with genotype 1 and high viral loads
Acronym CITATION
Scientific Title Comprehensive and individualized trial of teraprevir/peginterferon alpha-2b/ribavirin for chronic hepatitis C patients with genotype 1 and high viral loads
Scientific Title:Acronym CITATION
Region
Japan

Condition
Condition chronic hepatitis C patients with genotype 1 and high viral loads
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To increase SVR ratio
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes virological response
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria 1. patients with a positive HCV-RNA in the serum (more than or equal to 5.0 log IU/mL)
2. patients with genotype 1a or 1b
3. patients who gave consent in writing
Key exclusion criteria 1. chronic hepatitis such as autoimmune hepatitis and alcoholic hepatitis
2. pregnant women, women who may be expecting a child or lactating woman
3. women of child-bearing potential and their partner who cannot use birth control during administration and for 6 months after completion of administration
4. male partner for a pregnant woman, who cannot use birth control during administration and for 6 months after completion of administration
5. patients with past history of hypersensitivity to IFN or bovine-derived material
6. patients with past history of hypersensitivity to ribavirin and other nucleoside analog
7. patients with past history of hypersensitivity to biological products
such as vaccine
8. patients with uncontrolled diabetes mellitus
9. patients with uncontrolled heart disease
10. patients with hemoglobinopathy
11. chronic renal failure or severe renal dysfunction with less than 50 mL/min Ccr
12. patients with severe depression, suicidal thinking or suicide attempt or past history of any of these diseases
13. patients with severe liver dysfunction
14. patients with interstitial pneumonitis
15. patients with past history of drug hypersensitivity or tendency to develop allergy
16. patients receiving Shosaikoto
17. patients judged as inappropriate by the doctor
Target sample size 73

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Sato
Organization Gunma University Graduate School of Medicine
Division name Department of Medicine and Molecular Science
Zip code
Address 3-39-22
TEL 027-220-8127
Email satoken@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Sato
Organization Gunma University Graduate School of Medicine
Division name Department of Medicine and Molecular Science
Zip code
Address Department of Medicine and Molecular Science
TEL 027-220-8127
Homepage URL
Email satoken@gunma-u.ac.jp

Sponsor
Institute Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization Gunma University Graduate School of Medicine
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
2013 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially 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
2011 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 01 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 prospective cohort

Management information
Registered date
2013 Year 04 Month 24 Day
Last modified on
2015 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012365

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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