PEG-IFN alpha 2a add-on therapy for chronic hepatitis B patients treated with Entecavir

PEG-IFN alpha 2a add-on therapy for chronic hepatitis B patients treated with Entecavir - PEG-IFN add-on study for chronic hepatitis B

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008693

Enrollment

Registered

2012-08-16

Start date

2012-08-16

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

PEG-IFN alpha 2a 90mcg, subcutaneous injection, once a week for 48 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with chronic hepatitis B treated with Entecavir, are fit with all criteria. 1) HBsAg >= 100IU/mL 2) Neutrophil counts >= 1500/mm3, Platelet counts >= 70000/mm3, Hemoglobin concentration >= 10g/dL 3) Written informed concent

Exclusion criteria

Exclusion criteria: 1) Women of childbearing potential and pregnancy, lactating women 2) Concomitant herbal medication of Sho-saiko-to 3) History of interstitial pneumonia 4) Autoimmune hepatitis 5) Severe depression or psychosomatic disorders 6) Drug allegy against interferon 7) Allegic to vaccine or biological preperations 8) Other conditions considered inappropriate by attending physician

Design outcomes

Primary

Measure	Time frame
Rate of HBsAg <100IU/mL at 24 weeks after the end of treatment	—

Countries

Japan

Contacts

Public ContactHideyuki Tamai

Wakayama Medical University Second department of internal medicine

tamahide@wakayama-med.ac.jp073-447-2300

Outcome results

None listed

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