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Safety and efficacy of different antiviral therapy in patients with chronic hepatitis B complicated with type 2 diabetes mellitus

China Hepatitis Prevention and Treatment Foundation - Clinical Management Research System of Chronic Hepatitis B

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200062475
Enrollment
Unknown
Registered
2022-08-08
Start date
2022-08-08
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

Chronic hepatitis B

Interventions

Group 1:ETV/TDF continuation treatment group
Group 2:ETV/TDF transferred toTAF group

Sponsors

Beijing Youan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Chronic hepatitis B patients, men and women; 2. Age: 18-65 years old; 3. The diagnosis of chronic hepatitis B conforms to the prevention and treatment guidelines of chronic hepatitis B (2019 edition), and the diagnosis of diabetes conforms to the Prevention and treatment guidelines of Type 2 diabetes (2017 edition); 4. After oral drug or insulin treatment, blood glucose control was stable, HbA1c(%)<=7%; 5. The previous single application of ETV/TDF antiviral therapy lasted more than 12 months, but the total duration of previous antiviral therapy was less than 10 years.

Exclusion criteria

Exclusion criteria: 1. Complicated with hepatitis A, E, C, and other hepatitis virus infection; 2. Acute or chronic renal failure; 3. With other serious active physical and mental diseases, including uncontrolled primary kidney, heart, lung, vascular, neurological, immune deficiency disease or malignant tumor; 4. Acute complications of diabetes, such as diabetic ketosis, hyperosmolar coma, acidosis; 5. Those who cannot cooperate with monitoring and follow-up and refuse to sign the informed consent; 6. Pregnancy.

Design outcomes

Primary

MeasureTime frame
Blood lipids;

Secondary

MeasureTime frame
Serum creatinine;Quantification of hepatitis B virus ;

Countries

China

Contacts

Public ContactBin Xu

Beijing Youan Hospital, Capital Medical University

xubin1016@126.com+86 13718630822

Outcome results

None listed

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