A multicenter open-label randomized controlled trial comparing interferon-nucleoside/nucleotide analogues add-on therapy with interferon-nucleoside/nucleotide analogues sequential therapy for chronic hepatitis B.

A multicenter open-label randomized controlled trial comparing interferon-nucleoside/nucleotide analogues add-on therapy with interferon-nucleoside/nucleotide analogues sequential therapy for chronic hepatitis B. - Interferon-nucleoside/nucleotide analogues add-on and sequential therapy for chronic hepatitis B: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021768

Enrollment

Registered

2016-04-06

Start date

2016-04-04

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

Peginterferon-nucleoside/nucleotide analogues sequential therapy arm:For patients who take nucleoside/nucleotide analogues orally, 90 to 180ug of PEG-IFN alpha-2a is administered subcutaneously once a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Chronic hepatitis B patients who take nucleoside/nucleotide analogues at least for three months. (2) Chronic hepatitis patients without advanced liver fibrosis (up tp F2). (3)[0020]Patients who well understand the risk of exacerbation of hepatitis after stopping nucleoside/nucleotide analogues and can be closely watched.

Exclusion criteria

Exclusion criteria: (1)The patients who are prescribed with Sho-saiko-toh. (2)The patients who had or have interstitial pneumonia. (3)The patients with autoimmune hepatitis. (4)The patients who have an allergy against interferon and other medications in the study. (5)The patients who have allergy against vaccine or other biologics. (6)The patients with a severe mental disease such as depression, a suicide consideration, or suicide project, or the past history of such conditions. (7)The patients with liver cirrhosis or severe hepatic diseases. (8)The patients with untreated hepatic cancers. (9)The patients who were judged inappropriate for the study by the doctor.

Design outcomes

Primary

Measure	Time frame
The number of patients who achieve > 0.5 logU/ml reduction of HBsAg after 24 and 48 weeks.	—

Secondary

Measure	Time frame
(1)Change of ALT (2)Change of HBeAg (3)HBV-specific immunological reactions	—

Countries

Japan

Contacts

Public ContactShinichi Asabe

Saitama Medical Center, Jichi Medical University Department of Gastroenterology

jmukanzo@gmail.com048-647-2111

Outcome results

None listed

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