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.

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. - A randomized trial of teprenone for chronic hepatitis C patients treated with combination therapy.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001391

Enrollment

200

Registered

2009-03-01

Start date

2008-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis C patients with genotype 1 and high viral load (&gt

Interventions

Peginterferon alpha-2b plus ribavirin Teprenone in combination with peginterferon alpha-2b plus ribavirin.

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Negative result of qualitative HCV RNA test 24 weeks after terminating therapy.	—

Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Countries

Japan

Contacts

Public ContactYoshiaki Iwasaki

Okayama University Hospital Department of Gastroenterology and Hepatology

yiwasaki@cc.okayama-u.ac.jp086-235-7219

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026