A Prospective, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Entecavir in naive Chronic Hepatitis B treatment- Tertiary care center in Thailand.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250823001

Enrollment

Registered

2025-08-23

Start date

2025-09-01

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

Lack of data about entecarvir use for treatment of chronic hepatitis B virus (HBV) infection in Thailand. chronic hepatitis B virus , entecarvir

Interventions

Entecavir is a nucleoside reverse transcriptase inhibitor (NRTI) used for the treatment of chronic hepatitis B virus (HBV) infection in adults and in children aged 2 years and older weighing more than

No Intervention Drug

Entecavir

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 to 75 years with chronic hepatitis B virus (HBV) infection. 2.Patients diagnosed as either HBeAg-positive or HBeAg-negative. 3.Patients with HBV DNA levels >2,000 IU/mL together with alanine aminotransferase (ALT) >1.5 times the upper limit of normal (ULN) on at least two occasions within 3 months, or with liver fibrosis stage greater than F2 (defined as AST-to-platelet ratio index [APRI] >0.5 or FIB-4 >1.45). 5.Patients with advanced fibrosis or cirrhosis. 6.Patients who voluntarily agree to participate in the study and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with a history of prior treatment with nucleos(t)ide analogues (NAs) such as lamivudine, TAF, or TDF, or those who have previously received therapy for chronic hepatitis B, such as pegylated interferon-alpha (pegIFN-alpha ). 2.Patients with concomitant hepatitis C or hepatitis D virus infection. 3.Patients with concomitant human immunodeficiency virus (HIV) infection. 4.Patients with a history of hepatocellular carcinoma or pancreatic cancer. 5.Pregnant patients. 6.Patients with renal function <15 mL/min who are receiving renal replacement therapy.

Design outcomes

Primary

Measure	Time frame
Virological response : Hepatitis B Virus Deoxyribonucleic acid 12 months Real-Time Polymerase Chain Reaction	—

Secondary

Measure	Time frame
Adverse drug reaction 12 months Observational and laboratory data, and self report questionaire ,Alanine Aminotransferase (ALT) 12 months Laboratory data,serum creatinine (Scr), estimated glomerular filtration rate(eGFR) 12 months Laboratory data,patient compliances 12 months questionnaire,Hepatitis B surface Antigen, Hepatitis B e-Antigen, Antibody to Hepatitis B e-Antigen 12 months laboratory data	—

Measure

Time frame

Adverse drug reaction 12 months Observational and laboratory data, and self report questionaire ,Alanine Aminotransferase (ALT) 12 months Laboratory data,serum creatinine (Scr), estimated glomerular filtration rate(eGFR) 12 months Laboratory data,patient compliances 12 months questionnaire,Hepatitis B surface Antigen, Hepatitis B e-Antigen, Antibody to Hepatitis B e-Antigen 12 months laboratory data

—

Countries

Thailand

Contacts

Public ContactNarisa Ruenroengbun

Department of Pharmaceutical care , Faculty of Pharmacy, Silpakorn University

ruenroengbun_n@su.ac.th034255800

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026