Biomarkers Guided Stopping NAs Treatment

Nanfang Hospital, Southern Medical University

Status

Unknown

Conditions

Chronic Hepatitis b

Treatments

Other: Stop NAs therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04519359

STOP-01

Details and patient eligibility

About

The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss in subjects who stop nucles(t)ide analogues (NAs) (Stop arm) compared to subjects who continue (Continue arm) Only subjects who already are on treatment with ETV, TDF or TAF monotherapy, and have achieved sustained virologic suppression (<20 IU/mL), HBeAg negativity, normal ALT for more than 1 year (pretreatment HBeAg + pts) or 3 years (pretreatment HBeAg - pts), plus qHBsAg <200 IU/mL, and HBV RNA or HBcrAg negativity will be included in this study. One treatment arm will stop the NAs therapy while the other treatment arm will continue the NAs therapy. Participants in the Stop arm will be monitored very closely with special focus on clinical relapse. If any participant in the Stop NAs arm exceeds one or more predefined limits for such flares or relapses, NAs treatment will be reinstituted.

Enrollment

195 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

18-65 years of old, male or female
Chronic hepatitis B patients
Received continuous ETV, TDF or TAF therapy for at least 1 year prior to screening and at screening
For patients with Hepatitis B e Antigen (HBeAg)-positive at the beginning of NAs therapy, documented hepatitis B virus <20 IU/mL, HBeAg seroconversion and ALT normalization for at least 1 year prior to screening and at screening
For patients with HBeAg-negative at the beginning of NAs therapy, documented hepatitis B virus <20 IU/mL, and ALT normalization for at least 3 year prior to screening and at screening
<= 9 kPa on Fibroscan assessment
qHBsAg <200 IU/mL within 24 weeks prior to screening
HBV RNA or HBcrAg negativity within 24 weeks prior to screening

Key Exclusion Criteria:

Experience of IFN treatment within 1 year prior to screening
Known cirrhosis
History of decompensated liver disease
History of clinical hepatic decompensation in the judgement of the investigator
Evidence of hepatocellular carcinoma
Serological evidence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus, or hepatitis D infection
Known hypersensitivity to TDF, its metabolites, or formulation excipients
History of malignant disease
Lactating females
Females wishing to became pregnant during the duration of the study
Subjects participating in another clinical trial