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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013784
Receipt No. R000016093
Scientific Title Telaprevir-based triple therapy significantly decreases the serum alpha-fetoprotein level in chronic hepatitis C patients: A prospective study
Date of disclosure of the study information 2014/04/22
Last modified on 2014/04/22

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Basic information
Public title Telaprevir-based triple therapy significantly decreases the serum alpha-fetoprotein level in chronic hepatitis C patients: A prospective study
Acronym Telaprevir-based triple therapy and serum alpha-fetoprotein level for chronic hepatitis C
Scientific Title Telaprevir-based triple therapy significantly decreases the serum alpha-fetoprotein level in chronic hepatitis C patients: A prospective study
Scientific Title:Acronym Telaprevir-based triple therapy and serum alpha-fetoprotein level for chronic hepatitis C
Region
Japan

Condition
Condition Chronic hepatitis C
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This prospective study was done to investigate the impact of the triple therapy on serum AFP level.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Decline of the AFP level by treatment
Key secondary outcomes

Base
Study type

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 Telaprevir (TVR) based triple therapy combined with pegylated-IFN-alpha (PEG-IFN-alpha) and ribavirin (RBV)
Interventions/Control_2 Dual therapy of PEG-IFN-alpha and RBV
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 Patient inclusion criteria for the study required patients to be infected with HCV genotype 1 and baseline serum HCV RNA positive (>5.0 log10 IU/mL).
Key exclusion criteria The exclusion criteria were as follows: (1) presence of HCC at enrollment, or development of HCC until 24 weeks after EOT; (2) shortening of treatment due to adverse effect, virological breakthrough, non-virological response (NVR), or dropout; (3) in dual therapy group, extension of standard 48-week therapy; (4) inadequate treatment dose of 80% or less assigned total cumulative dosage of each drug; (5) positivity for antibody to human immunodeficiency virus or positivity for hepatitis B surface antigen; (6) clinical or biochemical evidence of hepatic decompensation (Child-Pugh B or C, ascites, bleeding varices, or encephalopathy) at enrollment; (7) excessive active alcohol consumption (a daily intake of more than 60g of alcohol) or drug abuse; (8) other forms of liver disease (e.g., autoimmune hepatitis, alcoholic liver disease, hemochromatosis); or (9) treatment with antiviral or immunosuppressive agents prior to enrollment.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Furusyo, MD.
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL 092-642-5909
Email furusyo@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norihiro Furusyo, MD.
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL 092-642-5909
Homepage URL
Email furusyo@gim.med.kyushu-u.ac.jp

Sponsor
Institute Department of General Internal Medicine, Kyushu University Hospital
Institute
Department

Funding Source
Organization Department of General Internal Medicine, Kyushu University Hospital
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
2014 Year 04 Month 22 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
2005 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 06 Month 01 Day
Last follow-up date
2014 Year 04 Month 22 Day
Date of closure to data entry
2014 Year 04 Month 22 Day
Date trial data considered complete
2014 Year 04 Month 22 Day
Date analysis concluded
2014 Year 04 Month 22 Day

Other
Other related information

Management information
Registered date
2014 Year 04 Month 22 Day
Last modified on
2014 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016093

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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