A real world study for the effectiveness and safety of tenofovir tablets in the treatment of patients with chronic hepatitis B

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1800019508

Enrollment

Unknown

Registered

2018-11-15

Start date

2018-12-01

Completion date

Unknown

Last updated

2018-11-19

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

Conditions

Chronic Hepatitis B

Interventions

Case series:Tenofovir Disoproxil Fumarate,300mg Qd

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients appropriate for antival treatment according to EASL Clinical Practice Guidelines on the Management of Hepatitis B Virus Infection (2017), or the Guidelines on the Prevention and Treatment of Chronic Hepatitis B in China (2015) 2. HBsAg positive for at least 6 months; HBeAg positive or negative; 3. Treatment-naive patients; or 4. Treatment-experienced patients, including: (1) patients with prior resistance or poor response to Lamivudine; or (2) patients with prior resistance or poor response to Adefovir; or (3) patients with prior resistance or poor response to Telbivudine; or (4) patients with prior NAs treatment related adverse reactions; or (5) patients with prior or currently poor response to interferon; or (6) patients with relapse after drug withdrawal; or (7) patients who physicians consider appropriate for TDF treatment; 5. Voluntary participating in the study and signing the informed consent form.

Exclusion criteria

Exclusion criteria: Patients with one of the followings: 1. Patients with hepatic failure; or 2. Patients with primary/metastatic liver cancer; other cancer (not including those who have been cured); or 3. Creatinine clearance rate <50 ml/min.

Design outcomes

Primary

Measure	Time frame
Liver Function;Kidney Function;Blood Phosphate;Glomerular Filtration Rate;Blood Routine test;HBV-Marker;HBV DNA quantity;Urine Routine;Urine Protein Quantity;Abdominal B Ultrasound;Coagulation Function;Fibroscan or Fibrotouch;Thyroid Function;Bone Mineral Density;Liver Tissue Pathology;Quality of Life;	—

Secondary

Measure	Time frame
Glucose;Alpha Fetoprotein;Hepatitis C Virus Quantity;	—

Countries

China

Contacts

Public ContactZhongping Duan

Beijing You'an Hospital, Capital Medical University

Duan2517@163.com+86 13366425670

Outcome results

None listed

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