An open-label, randomized, controlled trial comparing different dosing regimens with peginterferon alpha-2a plus ribavirin in patients with chronic hepatitis C.

An open-label, randomized, controlled trial comparing different dosing regimens with peginterferon alpha-2a plus ribavirin in patients with chronic hepatitis C. - A randomized trial of peginterferon alpha-2a plus ribavirin for chronic hepatitis C.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001033

Enrollment

240

Registered

2008-02-29

Start date

2007-09-01

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 with serogroup 1 and high viral load (&gt

Interventions

Starting with a standard dose of ribavirin in combination with peginterferon alpha-2a, followed by ribavirin reduction by 200 mg/day upon a decline of hemoglobin concentration by 2 g/dL or more from b

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Chronic hepatitis C with HCV serogroup 1 and high viral load (HCV RNA >= 100 KIU/mL). 2. 60 years-old or older.

Exclusion criteria

Exclusion criteria: 1. Pregnant or under breast feeding. 2. Allergic to ribavirin or other nucleoside preparations. 3. Uncontrolled cardiovascular diseases. 4. Abnormal hemoglobinemia. 5. Chronic renal failure or creatinine clearance value less than 50 mL/min. 6. Depression or psychiatric disorders. 7. Sever or decompensated liver disease. 8. Autoimmune liver diseases. 9. White blood cell count <3,000/microL, neutrophil count <1,500/microL, platelet count <90,000/microL, or hemoglobin concentration <12 g/dL. 10. Allergic to pegylated interferon alpha-2a or other interferon preparations. 11. Allergic to vaccine or biological preparations. 12. Concomitant herbal medication such as Sho-saiko-to. 13. Other conditions considered inappropriate by attending physician.

Design outcomes

Primary

Measure	Time frame
Negative results of qualitative HCV RNA test at weeks 4, 12, 24, and 48 during treatment and 24 weeks after terminating therapy.	—

Secondary

Measure	Time frame
1. Normalization of alanine aminotransferase levels at weeks 24 and 48 during treatment and 24 weeks after terminating therapy. 2. Adverse event and laboratory abnormality (changes in neutrophil count, platelet count, and hemoglobin concentration). 3. The incidence rates of completion of therapy, dose reduction, and discontinuation of therapy. 4. Assessment of quality of life. 5. HCV Core and NS5A ISDR amino acid replacement and virological response.	—

Measure

Time frame

1. Normalization of alanine aminotransferase levels at weeks 24 and 48 during treatment and 24 weeks after terminating therapy. 2. Adverse event and laboratory abnormality (changes in neutrophil count, platelet count, and hemoglobin concentration). 3. The incidence rates of completion of therapy, dose reduction, and discontinuation of therapy. 4. Assessment of quality of life. 5. HCV Core and NS5A ISDR amino acid replacement and virological response.

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Countries

Japan

Contacts

Public ContactYoshiaki Iwasaki

Okayama University Hospital Department of Gastroenterology and Hepatology

yiwasaki@cc.okayama-u.acjp086-235-7219

Outcome results

None listed

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