PegIFNalpha-2a treatment added-on entecavir for HBeAg and HBV DNA negative patients treated with long-term entecavir

PegIFNalpha-2a treatment added-on entecavir for HBeAg and HBV DNA negative patients treated with long-term entecavir - PegIFNalpha-2a treatment added-on entecavir

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012454

Enrollment

100

Registered

2013-12-05

Start date

2013-12-09

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 interferon therapy added-on entecavir Entecavir mono therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Entecavir-treated (more than 1 year) CHB patients met the following criteria, 1) HBsAg-positive 2) HBeAg-negative 3) HBV DNA-undetectable (continuous undetection for more than 1 year)

Exclusion criteria

Exclusion criteria: 1) Patients receiving Chinese herb (sho-sai-ko-to) 2) Patients with history of interstitial pneumonia 3) Patients with auto immune hepatitis 4) Patients with hypersensitivity to interferon 5) Patients with hypersensitivity to biological agents 6) Patients with neutropenia (<1500/mm3), thrombocytopenia (<90000/mm3), or anemia (Hb<12g/dL) 7) Cirrhotic patients 8) Patients with history of HCC 9) Doctors consider inadequate

Design outcomes

Primary

Measure	Time frame
The reduction of HBsAg and the number of patients who achieve >0.5 log U/mL at 48 weeks after randomization	—

Secondary

Measure	Time frame
1) The change of HBsAg levels at 1Y, 2Y and 3Y after peg interferon add-on treatment 2) Clearance rates of HBsAg and rates of < 100 U/mL or <1000 U/mL	—

Countries

Japan

Contacts

Public ContactTetsuya Hosaka

Toranomon Hospital Hepatology

hosa-p@toranomon.gr.jp044-877-5111

Outcome results

None listed

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