UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013784 |
|---|---|
| Receipt number | 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 18:59:04 |
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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
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
furusyo@gim.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of General Internal Medicine, Kyushu University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016093
