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Efficacy and safety of long-term treatment with tenofovir amibufenamide in patients aged 65 years and over with chronic hepatitis B

Efficacy and safety of long-term treatment with tenofovir amibufenamide in patients aged 65 years and over with chronic hepatitis B

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064306
Enrollment
Unknown
Registered
2022-10-02
Start date
2022-10-01
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

Interventions

therapy group:Medical treatment+Oral tenofovir amibufenamide 1 tablet daily

Sponsors

Linyi People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age 65 and above; 2. Patients with chronic hepatitis B who meet the diagnostic criteria of "Guidelines for the Prevention and Treatment of Chronic Hepatitis B" (2019 Edition); 3. HBV DNA can be detected; 4. Patients who agree to participate in this clinical trial and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Under the age of 65; 2. Patients co-infected with human immunodeficiency virus or requiring long-term immunosuppressive therapy; 3. Those who plan to undergo an organ transplant or have received an organ transplant; 4. Patients with hepatocellular carcinoma or other malignant tumors; 5. Patients with other liver diseases, including viral hepatitis C, alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease, etc.; 6. Creatinine clearance less than 50ml/min before enrollment; 7. Child-Pugh score greater than 9 (Grade C); 8. Lactose intolerant; 9. History of alcohol or drug abuse within the last 1 year; 10. Male subject's spouse has a pregnancy plan in the next 2 years; 11. Patients who have participated in clinical trials of other drugs within the last 3 months; 12. Patients who cannot adhere to or are unwilling to participate in the study, or those who are deemed unsuitable by the investigator to participate in this clinical study.

Design outcomes

Primary

MeasureTime frame
HBV DNA;Biochemical tests;HBsAg;HBeAg;Bone mineral density;

Countries

China

Contacts

Public ContactFeng Gao

Linyi People's Hospital

gao_feng1166@163.com+86 13969956366

Outcome results

None listed

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