Observation of the efficacy of tenofovir amibufenamide monotherapy in nucleoside (acid) analogues in naive or treatment-experienced CHB patients

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200066338

Enrollment

Unknown

Registered

2022-12-01

Start date

2022-07-01

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

Chronic hepatitis B virus infection

Interventions

tenofovir amibufenamide monotherapy group:No

tenofovir disoproxil fumarate monotherapy group:No

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ?All patients gave informed consent to participate in the study and signed the informed consent; ?Age from 18 to 65, gender is unlimited; ?In line with the clinical diagnosis of chronic hepatitis B; ?HBsAg remained positive for at least 6 months at screening; ?Primary patients: naive patients who meet the requirements of hepatitis B treatment; patients treated (using nucleotide analogues for at least 48 weeks): patients treated with hepatitis B with poor antiviral treatment or existing renal and bone safety problems.

Exclusion criteria

Exclusion criteria: ?Evidence suggests that hepatocellular carcinoma or serum alpha-fetoprotein is greater than 100g / L; ?There are obvious signs of liver function decompensation, such as ascites, hepatic encephalopathy, esophageal and gastric fundus varicose vein rupture and bleeding; ?Active hepatitis associated with type C or D viral hepatitis, AIDS, autoimmune hepatitis and other causes; ?A history of allergy to nucleoside or nucleoside analogues; ?Platelet count less than 50×109 / L or hemoglobin less than 100g / L or albumin less than 30 g / L or total bilirubin greater than 2.5×ULN; ?Patients with severe cardiopulmonary abnormalities, advanced tumors, the central nervous system (such as a history of epilepsy), or other systemic serious or progressive diseases; ?Patients with neurological and mental disorders and unable to cooperate or unwilling to cooperate; ?Pregnancy or breastfeeding women or those with recent family plans; ?Unable to agree or unlikely to complete a two-year follow-up after inclusion;

Design outcomes

Primary

Measure	Time frame
HBV DNA quantification;HBsAg?HBsAb?HBeAg?HBeAb?HBcAb quantification;ALT;AST;Blood routine;renal function;electrolyte;	—

Countries

China

Contacts

Public ContactShuangsuo Dang

The Second Affiliated Hospital of Xi'an Jiaotong University

dang212@126.com13992896471

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026