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Study on the Effects of Long-term Use of Oral Nucleoside (Nucleotide) Analogues on Renal Function and Bone Mineral Density in Patients with Chronic Hepatitis B

Study on the Effects of Long-term Use of Oral Nucleoside (Nucleotide) Analogues on Renal Function and Bone Mineral Density in Patients with Chronic Hepatitis B

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111953
Enrollment
Unknown
Registered
2025-11-07
Start date
2019-09-01
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

Chronic Hepatitis B

Interventions

A (Review):None
B (Forward-looking):None
C (Initial treatment):None

Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: The entire study enrolled 400 patients, including 300 patients in groups A and B who had received previous NAs treatment for over one year, and 100 patients in group C who were treatment-naive. Inclusion criteria: (Group A and Group B) 1. HBsAg positive or a history of CHB for more than 6 months; 2. The treatment course with NAs exceeds one year; 3. Age over 18 years old; 4. NAs Drug Categories: ETV 0.5 mg/d or ETV 1.0 mg/d or TDF 300 mg/d or LDT 600 mg/d or ADV 10 mg/d alone or in combination with LAM 100 mg/d; 5. Sign the written informed consent form. Inclusion criteria: (Group C) 1. HBsAg positive or a history of CHB for more than 6 months; 2. Treatment-naive patients: Defined as those who have not previously received approved or investigational antiviral drugs, and are now initiating ETV at 0.5 mg/day or TAF at 25 mg/day; 3. Age over 18; 4. Sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1.Co-infection with HCV/HDV/HIV; 2.Complicated with liver tumors and tumors of other organ systems; 3.Having severe kidney, cardiovascular, pulmonary or neurological diseases; 4.Requiring the use of immunotherapeutic drugs or antineoplastic drugs; 5.Patients planning to become pregnant, pregnant patients, and patients who cannot use contraception during the study; 6.Patients with a history of interferon treatment; 7.Patients with decompensated liver cirrhosis, including those with Child-Turcotte-Pugh (CTP) class B or C.

Design outcomes

Primary

MeasureTime frame
Bone Mineral Density(BMD);Bone Markers;Basic Biochemical Indicators;Five Hepatitis B Markers and HBV-DNA(Hepatitis B Virus Deoxyribonucleic Acid));

Countries

China

Contacts

Public ContactShang Jia

Henan Provincial People's Hospital

shangjia666@126.com+86 139 3840 1888

Outcome results

None listed

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