Status:
UNKNOWN
Biomarkers Guided Stopping NAs Treatment
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT04519359
Start Date
July 6 2020
End Date
June 30 2023
Last Update
August 19 2020
Active Locations (5)
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1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
2
Peking University People's Hospital
Beijing, Beijing Municipality, China
3
No. 1 Hospital affiliated to Jilin University
Changchun, Jilin, China
4
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China