Peginterferon or conventional interferon sequential entecavir treatment for hepatitis B e antigen positive chronic hepatitis B patients: a prospective randomized controlled trial

Peginterferon or conventional interferon sequential entecavir treatment for hepatitis B e antigen positive chronic hepatitis B patients: a prospective randomized controlled trial - Peginterferon or conventional interferon sequential entecavir treatment

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011666

Enrollment

100

Registered

2013-09-09

Start date

2013-09-09

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

Pegiterferon induction arm Conventional interferon (natural IFN-alpha) induction arm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: # Chronic hepatitis B patients with HBeAg positivity # Twice or more ALT flares # HBV DNA levels > 4.0 log copies/mL

Exclusion criteria

Exclusion criteria: 1. Prior exposure of interferon, antiviral agents, antitumoral agents, immunosupressive drugs, and radiotherapy within 6 months 2. HCV RNA positivity 3. Complicating other liver disease 4. The diagnosis of Liver cirrhosis, hepatic failure, and liver cancer 5. The history of hepatic encephalopathy, varices bleeding, and ascites 6. Complicating collagen disease 7. The history of interstitial pneumonia 8. Severe heart disease 9. The history of epilepsy 10. The history of depression 11. The history of abnormal thyroid function 12. The history of stroke 13. Severe diabetes 14. The history of malignant tumor within 5 years 15. The history of liver, kidney or bone marrow transplantation 16. Retinopathy 17. blood test abnormality as follows: (a) neutrophil < 1,500 /mm3 (b) platelets count < 90,000/ mm3 (c) Hb < 10 g/dL (d) prothrombin time > 20s or < 60% (e) ALT > 10 times ULN (f) total bilirubin > 2.0 mg/dL (g) albmin < 3.2 g/dL (h) creatinine clearance < 50 mL/min 18. Pregnancy 19. Doctors condider inadequate

Design outcomes

Primary

Measure	Time frame
The reduction of HBsAg (<1,000 IU/mL) at 48 weeks after initiating entecavir treatment	—

Secondary

Measure	Time frame
1. The following outcomes at 48 weeks after entecavir treatment (a) HBeAg seroconversion rates (b) The reduction of HBV DNA levels (<5.0 logcopies/mL) (c) ALT normal rates (d) HBeAg seroclearance (e) HBsAg seroclearance (f) HBsAg seroconversion 2. Kinetics of HBV DNA levels 3. Kinetics of HBsAg levels 4. Kinetics of HB core-related antigen levels 5. The chenge of immunological markers 6. The regression of liver fibrosis (measured by Fibroscan)	—

Measure

Time frame

1. The following outcomes at 48 weeks after entecavir treatment (a) HBeAg seroconversion rates (b) The reduction of HBV DNA levels (<5.0 logcopies/mL) (c) ALT normal rates (d) HBeAg seroclearance (e) HBsAg seroclearance (f) HBsAg seroconversion 2. Kinetics of HBV DNA levels 3. Kinetics of HBsAg levels 4. Kinetics of HB core-related antigen levels 5. The chenge of immunological markers 6. The regression of liver fibrosis (measured by Fibroscan)

—

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