Effect of switching therapy from nucleos(t)ide analogue to pegylated-interferon in patients with chronic hepatitis B

Effect of switching therapy from nucleos(t)ide analogue to pegylated-interferon in patients with chronic hepatitis B - Effect of switching therapy from nucleos(t)ide analogue to pegylated-interferon in patients with chronic hepatitis B

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012415

Enrollment

200

Registered

2013-11-27

Start date

2013-05-01

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

drug: PegIFN alfa 2a duration: PegIFN alfa 2a and nucleos(t)ide analogue combination therapy for 12 weeks and monotherapy of PegIFN alfa 2a for 36 weeks dose: PegIFN alfa 2a 90-180mcg s.c. weekly

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients with chronic hepatitis B treated with nucleos(t)ide analogue and HBV DNA < 4 log copies/mL for more than 1 year

Exclusion criteria

Exclusion criteria: under age of 20 significant liver fibrosis (F3-) coinfection with HCV / HDV / HIV coexistence with other chronic liver disease pregnant or breast-feeding women contraindication to scheduled drugs patients found to be inadequate by their doctors

Design outcomes

Primary

Measure	Time frame
decline rate of HB surface antigen, loss of HB surface antigen decline rate of HB core-related antigen suppression of HBV DNA (< 4 log copies/mL) ALT normalization HBe antigen seroconversion (among patients with HBe antigen) at 24 and 48 weeks after completing pegylated interferon treatment	—

Countries

Japan

Contacts

Public ContactRyoko Yamada

Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology

ryo726@gh.med.osaka-u.ac.jp06-6879-3621

Outcome results

None listed

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