Long-term safety and efficacy of Tenofovir Amibufenamide in patients with hBeAg-positive or hBeAg-negative chronic hepatitis B: a multicenter, open-label follow-up study

Long-term safety and efficacy of Tenofovir Amibufenamide in patients with HBeAg-positive or hBeAg-negative chronic hepatitis B: a multicenter, open-label follow-up study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100051284

Enrollment

Unknown

Registered

2021-09-17

Start date

2021-09-17

Completion date

Unknown

Last updated

2023-04-12

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

Conditions

HBeAg-positive or HBBeAg-negative chronic hepatitis B patients

Interventions

Experimental group:Amy tenofovir 25mg QD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Completed the pivotal Phase III clinical study of HS-10234-301.

Exclusion criteria

Exclusion criteria: 1. Completion of the pivotal Phase III clinical study of HS-10234-301 Interruption of TMF therapy for more than 24 weeks or subject continuous implementation of alternative, other commercially available HBV treatment regimens for more than 24 weeks. 2. Hepatocellular carcinoma diagnosed by imaging; 3. Severe existing kidney, cardiovascular and cerebrovascular or severe bone diseases (such as osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, rickets) or multiple fractures in the opinion of the investigator; 4. Currently receiving treatment by immunomodulators (such as corticosteroids), investigational drugs, nephrotoxic drugs or drugs that can adjust renal excretion; 5. Known hypersensitivity reactions to study drugs, metabolites or formulation excipients; 6. According to the investigator's judgment, current drinking or substance abuse may interfere with the subject's compliance with the research requirements; 7. Any other clinical condition or previous treatment that the investigator believes will make the subject unsuitable for participating in the study or unable to comply with the medication requirements.

Design outcomes

Primary

Measure	Time frame
Serum Hepatitis B Virus deoxyribonucleic acid;	—

Secondary

Measure	Time frame
glutamic-pyruvic transaminase;Degree of liver fibrosis;Quantitative detection of HBV serology;Creatinine clearance; blood routine examination;blood biochemistry;Physical examination;vital signs;weight;glomerular filtration rate(GFR);Abdominal ultrasonography;Transient Elastograph;routine urine test;	—

Countries

China

Contacts

Public ContactWuJie

Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

lic15@hspharm.com+86 18652100702

Outcome results

None listed

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