Randomised clinical trial of interferon rebound therapy for chronic hepatitisB patients

Randomised clinical trial of interferon rebound therapy for chronic hepatitisB patients - Interferon rebound therapy for chronic hepatitisB patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009159

Enrollment

100

Registered

2012-10-21

Start date

2012-04-01

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patient who obtains agreement for participation in present study (2) Aminotransferase level >=31IU/L (3)HBeAg-positive and HBV DNA levels >= 5 log IU/mL

Exclusion criteria

Exclusion criteria: (1)Cirrhosis or hepatic failure such as chronic liver diseases, e.g. autoimmune hepatitis and alcoholic hepatitis (2)History of pneumonitis (3) Severe other diseases (4)Severe mental disorders (5)Pregnant woman or woman who has possibility of pregnancy or woman while suckling (6)Doctor judged patient as inappropriate person in this trial

Design outcomes

Primary

Measure	Time frame
HBe seroconversion and the suppression of HBV DNA levels to below 5.0Log copies/ml and the normalization of alanine aminotransferase levels at 24 weeks treatment of interferon therapy or Nucleoside analogue therapy	—

Secondary

Measure	Time frame
HBe seroconversion and undetectable HBV DNA and normalization of alanine aminotransferase levels and negative HBeAg and negative HBsAg and HBs seroconversion and HBsAg and HBcrAg	—

Countries

Japan

Contacts

Public ContactYoshiyuki Suzuki

Toranomon Hospital Department of Hepatology

044-877-5111

Outcome results