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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001391
Receipt No. 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 2019/04/03

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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
Email 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
Email yiwasaki@cc.okayama-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Okayama University Hospital
Institute
Department

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
Email 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 No longer recruiting
Date of protocol fixation
2008 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 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
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001563

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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