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HBsAg seroclearance in non-cirrhotic, HBeAg-negative chronic hepatitis B patients who discontinue tenofovir or entecavir

HBsAg seroclearance in non-cirrhotic, HBeAg-negative chronic hepatitis B patients who discontinue tenofovir or entecavir, prospective cohort study

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190609001
Enrollment
Unknown
Registered
2019-06-09
Start date
2019-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBsAg seroclearance HBsAg seroclearance&#44

Interventions

Non&#45
cirrhotic HBeAg negative CHB patients who was treated with tenofovir for at least 3 years with decided to discontinue tenofovir ,Non&#45
cirrhotic HBeAg negative CHB patients who was treated with tenofovir for at least 3 years with decided to continue tenofovir,Non&#45
cirrhotic HBeAg negative CHB patients who was treated with entecavir for at least 3 years with decided to discontinue entecavir,Non&#45
cirrhotic HBeAg negative CHB patients who was treated with entecavir for at least 3 years with decided to continue entecavir
Experimental Drug,Active Comparator Drug,Experimental Drug,Active Comparator Drug
Tenofovir discontinuation,Tenofovir continuation,Entecavir discontinuation,Entecavir continuation

Sponsors

Faculty of Medicine Siriraj Hospital
Lead Sponsor
The Gastroenterological Association of Thailand (GAT)
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age > 18 years old 2. Chronic hepatitis B eAg negative (ตั้งแต่แรกวินิจฉัย) 3. On treatment of TDF or ETV at least 3 years 4. HBV DNA F3 ) 6. No history of hepatic decompensation 7. CTP A (serum total bilirubin 3.5 mg/dl, INR 12 gm/dL, platelets > 100,000 mm3

Exclusion criteria

Exclusion criteria: 1. Transient elastography > 10 at least 6 months before enrollment 2. Creatinine clearance < 50 3. Poor compliance 4. Co&#45;existing hepatocellular carcinoma or others malignancy 5. Co&#45;existing with HIV or HCV infection 6. Pregnancy or breast feeding 7. Diagnosis of chronic liver disease from others etiology eg. AIH &#44; Alcoholic liver disease 8.On immunosuppresive drugs or Post organ transplant

Design outcomes

Primary

MeasureTime frame
HBsAg seroclearance 48 week after discontinuation of NUCs prevalance of HBsAg seroclearance—

Secondary

MeasureTime frame
Association factors of HBsAg seroclearance at baseline before discontinuation of NUCs quantitative HBsAg&#44; HBVcrAg&#44; HBV RNA ,HBsAg seroconversion 48 week after discontinuation of NUCs prevalance of HBsAg seroconversion,Virological and clinical relapse at 12 &#44;24&#44; 36 &#44;48 wk Rate of virological and clinical relapse,Adverse events at 12 &#44;24&#44; 36 &#44;48 wk Hepatic encephalopathy&#44; Liver failure&#44; Death—

Contacts

Public ContactOnuma Sattayalertyanyong

Division of Gastroenterology &#44; Faculty of medicine&#44; Siriraj hospital

sos_cat@hotmail.com0816165389

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026