Phase
Condition
Hepatitis B
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 andat screening
For patients with Hepatitis B e Antigen (HBeAg)-positive at the beginning of NAstherapy, documented hepatitis B virus <20 IU/mL, HBeAg seroconversion and ALTnormalization for at least 1 year prior to screening and at screening
For patients with HBeAg-negative at the beginning of NAs therapy, documented hepatitisB virus <20 IU/mL, and ALT normalization for at least 3 year prior to screening and atscreening
<= 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
Exclusion
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), hepatitisC 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
Study Design
Connect with a study center
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing
ChinaActive - Recruiting
Peking University People's Hospital
Beijing, Beijing
ChinaActive - Recruiting
No. 1 Hospital affiliated to Jilin University
Chang chun, Jilin
ChinaActive - Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning
ChinaActive - Recruiting
Ruijin Hospital
Shanghai, Shanghai
ChinaActive - Recruiting
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