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An open-label, randomized, controlled study of treatment duration of peginterferon alpha-2a monotherapy in patients with chronic hepatitis C

An open-label, randomized, controlled study of treatment duration of peginterferon alpha-2a monotherapy in patients with chronic hepatitis C - A randomized trial of peginterferon alpha-2a for chronic hepatitis C

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001067
Enrollment
270
Registered
2008-03-31
Start date
2004-03-01
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 genotype 2a/2b or genotype 1b and low viral load (&lt

Interventions

PEG-IFN alpha-2a weekly for 24 weeks in patients with negative results of HCV RNA test at week 4 of therapy (Group A) PEG-IFN alpha-2a weekly for 48 weeks in patients with negative results of HCV RNA

Sponsors

Japanese Consortium for the Study of Liver Diseases
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The following patients with chronic hepatitis C were eligible to enter the trial. 1) 20 years-old or older 2) HCV genotype 2a/2b or genotype 1b and HCV RNA <100 KIU/mL 3) Laboratory test at entry: 1. Neutrophil count >=1,500/mm3 2. Platelet count >=90,000/mm3 3. Hemoglobin concentration >= 10 g/dL 4) Patients who provided written informed consent to participate the study prior to enrollment

Exclusion criteria

Exclusion criteria: The following patients were excluded. 1. Concomitant herbal medication of Sho-saiko-to 2. Autoimmune hepatitis, alcoholic liver injury, or chronic liver diseases with other underlying causes 3. Allergic to pegylated interferon alpha-2a or other interferon preparations 4. Allergic to vaccine or biological preparations 5. Liver cirrhosis, decompensated liver disease, hepatocellular carcinoma, or other malignant diseases 6. Depression or psychiatric disorders 7. Other conditions considered inappropriate by attending physician

Design outcomes

Primary

MeasureTime frame
Negative results of qualitative HCV RNA test at 24 weeks after terminating therapy

Countries

Japan

Contacts

Public ContactYoshiaki Iwasaki

Okayama University Hospital Department of Gastroenterology and Hepatology

086-235-7219

Outcome results

None listed

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