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Study on the difference of T cell effects of nucleos(t)ide analogues (NAs) in treatment of hepatitis B virus infections

Multi-center prospective study and promotion on the different effects of antiviral drugs on the immune and inflammatory statuses of chronic hepatitis B

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100054212
Enrollment
Unknown
Registered
2021-12-11
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-11-14

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

Conditions

Chronic Hepatitis B

Interventions

ETV(Entecavir) treatment goup:No
TDF(Tenofovir disoproxil fumarate) treatment goup:No
TAF(Tenofovir alafenamide fumarate) treatment goup:No
Combination treatment (ETV+TDF/TAF) group:No

Sponsors

Hwa Mei Hospital, University of Chinese Academy of Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, no gender limit; 2. For patients with chronic HBV infection (HBeAg +/- chronic hepatitis B, liver cirrhosis, hepatocellular carcinoma), the diagnostic criteria are based on the Guidelines for Diagnosis and Treatment of Liver Cirrhosis, Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2019 Edition) and Guidelines for Prevention and Treatment of Chronic Hepatitis B (2019 Edition); 3. The indications for antiviral treatment comply with the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 Edition); 4. Volunteer to participate in the research, agree to cooperate with the researcher in specimen and data collection, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women; 2. Mental illness, unable to cooperate to complete the project research; 3. Persons co-infected with HAV, HCV, HDV, HEV and HIV; 4. Severe circulatory, neurological and immune system diseases; 5. Subjects with poor compliance; 6. Other situations that the researcher believes are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
biochemical response;virological response;serological response;inflammation and immunological indicators;functional cure index;

Countries

China

Contacts

Public ContactHu Airong

Hwa Mei Hospital, University of Chinese Academy of Science

huairong6666@126.com+86 13968369377

Outcome results

None listed

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