UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001563