Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease(OCEAN PROJECT)

PHASE4RecruitingINTERVENTIONAL
Enrollment

1,500

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Nonalcoholic Fatty Liver DiseaseChronic Hepatitis b
Interventions
DRUG

Peg-Interferon α

Peg IFN-α injection was subcutaneously injected 180 μg weekly on the first day of the first week, and NAs was administered daily according to the standard dosage of each drug. For example, HBsAg sero-conversion is achieved within 48 weeks of treatment, Peg IFNα combined with NAs or PEG-IFNα monotherapy was continued for 12 weeks, with a maximum of 96 weeks, and follow-up up to 240 weeks after treatment. If HBsAg negative sero-conversion is not achieved within 48 weeks of treatment, the maximum duration of PEG-IFNα is not more than 96 weeks. If Peg IFNα combined NAs regimen is used, NAs can be continued until the drug can be ended (if HBsAg negative conversion is achieved, NAs should be ended after consolidation therapy not less than 24 weeks; if HBsAg negative conversion is not achieved, NAS should be continued), followed up to 240 weeks after treatment.

Trial Locations (5)

Unknown

RECRUITING

Ningbo No.2 Hospital, Ningbo

RECRUITING

Ruian People's Hospital, Rui’an

RECRUITING

The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou

RECRUITING

Wenzhou People's Hospital, Wenzhou

RECRUITING

Yueqing People's Hospital, Yueqing

All Listed Sponsors
lead

First Affiliated Hospital of Wenzhou Medical University

OTHER