Assessment of efficacy and safety of PEG-IFN alpha-2a administration into patients with chronic hepatitis B on nuleoside analogue

Assessment of efficacy and safety of PEG-IFN alpha-2a administration into patients with chronic hepatitis B on nuleoside analogue - Usefulness of PEG-IFN alpha-2a treatment in combination with nucleoside analogue

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015633

Enrollment

100

Registered

2023-12-31

Start date

2014-11-10

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

48-week PEG-IFN alpha-2a treatment for patients with chronic hepatitis B on nucleoside analogue Pursue nucleoside analogue treatment for patients with chronic hepatitis B, without PEG-IFN alpha-2a adm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with chronic hepatitis B who have been treated with nucleoside analogue 2. Patients whose informed consent was obtained

Exclusion criteria

Exclusion criteria: 1. Patients with advance liver fibrosis 2. Patients with other serious diseases 3. Women who are pregnant or those who have a possibility to be pregnant. 4. Patients who have a contra-indication for receiving PEG-IFN alpha-2a treatment

Design outcomes

Primary

Measure	Time frame
1. Amount of HBs antigen at 12, 24, and 48 weeks after starting PEG-IFN alpha-2a administration 2. HBs antigen status for five years after stopping PEG-IFN alpha-2a administration	—

Secondary

Measure	Time frame
1. ALT and AFP levels after after starting PEG-IFN alpha-2a administration 2. Incidence of hepatocellular carcinoma 3. Pharmacoeconomics	—

Countries

Japan

Contacts

Public ContactKENGO TOMITA

National Defense Medical College Division of Gastroenterology and Hepatology, Department of Internal Medicine

kengo@ndmc.ac.jp04-2995-1609

Outcome results

None listed

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