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Open trial of the interferon therapy for withdrawal of entecavir for patient with chronic hepatitis B

Open trial of the interferon therapy for withdrawal of entecavir for patient with chronic hepatitis B - Open trial of the interferon therapy for withdrawal of entecavir for patient with chronic hepatitis B

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004906
Enrollment
15
Registered
2011-01-19
Start date
2011-01-01
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 B

Interventions

6 months of interferon or 6-12 months of peg-interferon treatment

Sponsors

Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patient with chronic hepatitis B treated with entecavir for more than 6 months. Just before the trial, HBV DNA less than 2.1 log copies/mL, HBs antigen positive, HBe antigen negative, ALT 30 IU/L or less, platelet count 150,000/µL or more Non-cirrhosis Without hepatocellular carcinoma

Exclusion criteria

Exclusion criteria: 1,allergy with entecavir, interferon or vaccination 2,interferon treatment before 6 months of the trial 3,pregnancy or lactation period 4,severe heart disease, chronic renal failure, depression, severe psychotic disease, liver cirrhosis, brain hemorrhage or infarction, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, HCV infection, autoimmune disease 5,treated with shosaiko-to

Design outcomes

Primary

MeasureTime frame
maintenance of ALT

Secondary

MeasureTime frame
HBe antigen, anti-HBe HBV DNA less than 4 log copies/mL

Countries

Japan

Outcome results

None listed

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