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A multicenter, real-world study of the clinical optimization of antiviral regimen in entecavir-experienced patients with chronic hepatitis B

A multicenter, real-world study of the clinical optimization of antiviral regimen in entecavir-experienced patients with chronic hepatitis B

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042089
Enrollment
Unknown
Registered
2021-01-13
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-04-19

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

Conditions

chronic hepatitis B

Interventions

HBV DNA positive group 1: ETV 0.5 mg/day, 96 weeks
HBV DNA positive group 2:TAF 25mg/d, 96 weeks
HBV DNA positive group 3:ETV0.5mg/d+TAF 25mg/d, 96 weeks
HBV DNA positive group 1:ETV0.5mg/d orTAF 25mg/d+ Peg IFN a, 96 weeks
HBV DNA negative group 2:ETV 0.5 mg/d, 96 weeks
HBV DNA negative group 3:TAF 25mg/d, 96 weeks

Sponsors

Beijing Youan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age over 18 years old, male or female; 2. Treated with ETV alone for more than 48 weeks (including patients who had previously been treated with Lamivudine, telbivudine or Adefovir) and are continuing ETV treatment; 3. HBsAg positive, HBeAg positive or negative; 4. Willing to accept treatment and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who received immunomodulatory therapy (such as Interferon) or traditional Chinese medicine anti-fibrotic drugs within 6 months, or who required systematic treatment outside the antiviral drug during the study period; 2. Pregnant women or lactating women 3. A history of mental illness (schizophrenia or severe depression), uncontrolled epilepsy, severe infection, retinal disease, heart failure, chronic obstructive pulmonary disease and other basic diseases.

Design outcomes

Primary

MeasureTime frame
HBV DNA;

Countries

China

Contacts

Public ContactHu Zhongjie

Beijing Youan Hospital, Capital Medical University

yfcyt@139.com+86 13501366613

Outcome results

None listed

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