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Study on usefulness of PEG-IFN alpha-2a administration to discontinue nucleos(t)ide analogue treatment in patients with chronic hepatitis B

Study on usefulness of PEG-IFN alpha-2a administration to discontinue nucleos(t)ide analogue treatment in patients with chronic hepatitis B - Usefulness of PEG-IFN alpha-2a to discontinue NA treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007045
Enrollment
100
Registered
2012-01-10
Start date
2012-02-01
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

Start PEG-IFN alpha 2a administration just after stopping NA.

Sponsors

Department of Medicine, Shinshu University School of Medicine
Lead Sponsor
Division of Hepatobiliary and Pancreatic Medicine, Hyogo College of Medicine
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with chronic hepatitis B who have been treated with NA for more than one years. 2. Patients who understand a risk of hepatitis relapse after stopping NA. 3. Patients who can be followed properly after stopping NA. 4. Patients whose informed consent was obtained.

Exclusion criteria

Exclusion criteria: 1. Patients with impaired liver function. 2. Patients with advance liver fibrosis. 3. Patients with other serious diseases. 4. Women who are pregnant or those who have a possibility to be pregnant. 5. Patients who have a contra-indication for receiving PEG-IFN alpha-2a treatment.

Design outcomes

Primary

MeasureTime frame
HBe antigen status, amount of HBV DNA, and ALT level at 24 and 48 weeks after stopping PEG-IFN administration.

Secondary

MeasureTime frame
1. HBe antigen status, amount of HBV DNA, and ALT level at 24 weeks after stopping PEG-IFN administration. 2. Changes in amount of viral antigens including HBs antigen during and after PEG-IFN administration.

Countries

Japan

Contacts

Public ContactEIJI TANAKA

Shinshu University School of Medicine Department of Medicine

etanaka@shinshu-u.ac.jp0263-37-2634

Outcome results

None listed

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