UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001391 |
|---|---|
| Receipt number | R000001563 |
| Scientific Title | An open-label, randomized, controlled trial to assess the efficacy and safety of teprenone in chronic hepatitis C patients concurrent with chronic gastritis treated with peginterferon alpha-2b plus ribavirin. |
| Date of disclosure of the study information | 2009/03/01 |
| Last modified on | 2021/04/23 15:53:42 |
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Basic information
Public title
An open-label, randomized, controlled trial to assess the efficacy and safety of teprenone in chronic hepatitis C patients concurrent with chronic gastritis treated with peginterferon alpha-2b plus ribavirin.
Acronym
A randomized trial of teprenone for chronic hepatitis C patients treated with combination therapy.
Scientific Title
An open-label, randomized, controlled trial to assess the efficacy and safety of teprenone in chronic hepatitis C patients concurrent with chronic gastritis treated with peginterferon alpha-2b plus ribavirin.
Scientific Title:Acronym
A randomized trial of teprenone for chronic hepatitis C patients treated with combination therapy.
Region
| Japan |
Condition
Condition
Chronic hepatitis C patients with genotype 1 and high viral load (>= 5 Log IU/mL) concurrent with chronic gastritis.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of teprenone in chronic hepatitis C patients concurrent with chronic gastritis treated with peginterferon alpha plus ribavirin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Negative result of qualitative HCV RNA test 24 weeks after terminating therapy.
Key secondary outcomes
1. Negative results of qualitative HCV RNA test at weeks 4, 8, 12, 24, and 48 during treatment and at terminating therapy.
2. The incidence rates of completion of therapy, dose reduction, and discontinuation of therapy.
3. Normalization of alanine aminotransferase levels at weeks 24 and 48 during treatment and 24 weeks after terminating therapy.
4. HCV Core and NS5A ISDR amino acid replacement and virological response.
5. Adverse events and laboratory abnormalities (changes in neutrophil count, platelet count, and hemoglobin concentration).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Peginterferon alpha-2b plus ribavirin
Interventions/Control_2
Teprenone in combination with peginterferon alpha-2b plus ribavirin.
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. Chronic hepatitis C with HCV genotype 1 and high viral load (HCV RNA >= 5 Log IU/mL).
2. Concurrent with chronic gastritis.
3. No signs of cirrhosis based on histological, imaging, or hematological parameters.
4. No detectable hepatocellular carcinoma by imaging modalities.
Key exclusion criteria
1. Allergic to peginterferon alpha-2b or other interferon preparations.
2. Allergic to vaccine or biological preparations.
3. Allergic to ribavirin or other nucleoside preparations.
4. Pregnant or under breast feeding.
5. Uncontrolled cardiovascular diseases.
6. Abnormal hemoglobinemia.
7. Chronic renal failure or creatinine clearance value less than 50 mL/min.
8. Severe depression or psychiatric disorders including a history of a suicide attempt.
9. Sever or decompensated liver disease or obstruction of biliary tract.
10. Vascular diseases of central nervous system.
11. Concomitant herbal medication such as Sho-saiko-to.
12. Autoimmune liver diseases.
13. Chronic liver diseases other than hepatitis C virus such as hepatitis B virus and excessive alcohol intake.
14. Other conditions considered inappropriate by attending physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Iwasaki |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Okayama-city, Okayama, Japan
TEL
086-235-7219
yiwasalo@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Iwasaki |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Okayama-city, Okayama, Japan
TEL
086-235-7219
Homepage URL
yiwasaki@cc.okayama-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Okayama University
Address
2-5-1, Shikata-cho, Kita-ku, Okayama 700-8558
Tel
086-251-7219
yiwasaki@okayama-u.ac.jp
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
| 2009 | Year | 03 | 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
| 2008 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2008 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 09 | Month | 24 | Day |
Last modified on
| 2021 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001563
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
