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A study on the treatment of patients with hypoviremia after treatment with HBV nucleoside (nucleotide) analogues (HBV)(micro-All Victory) project

A study on the treatment of patients with hypoviremia after treatment with HBV nucleoside (nucleotide) analogues (HBV)(micro-All Victory) project

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129000
Enrollment
Unknown
Registered
2026-07-29
Start date
2024-11-13
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Chronic Hepatitis B (CHB)

Interventions

Chronic hepatitis B observation group:None

Sponsors

The Third Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients with chronic hepatitis B were treated with first-line drugs such as ETV, tenofovir fumarate (TDF) or tenofovir fumarate (TAF) or emitinofovir (TMF) monotherapy for more than 48 weeks, serum HBV DNA could be detected by sensitive qPCR (the lowest detection limit was 20 IU/mL or 10 IU/mL) , but the compliance was excluded. 2. The age is 18 ~ 60 years old (including 18,60 years old) , sex is not limited. 3. No restriction on HBeAg status. 4. For subjects with modified NAS regimen, only ETV + TDF, TAF + ETV, ETV + TMF, and Nas monotherapy were enrolled Nas plus interferon group: enrolled only one NAs plus Peg IFN a-2b or two NAs plus Peg IFN a-2b; unadjusted patients: still receiving the original monotherapy; 5.Compliant and willing to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with decompensated cirrhosis or previous decompensated cirrhosis. 2.Use of interferon within 6 months; 3.Co-infection with other viruses, such as hepatitis A virus, Hepatitis C virus, hepatitis D virus, Hepatitis E virus, HIV; 4. In addition to hepatitis B accompanied by other serious physical and mental diseases, these include uncontrolled primary kidney, heart, lung, vascular, neurological, digestive, severe metabolic diseases (such as uncontrolled hyperthyroidism, severe complications of diabetes and adrenal diseases) , immunodeficiency, active or suspected malignant tumor or history of malignant tumor; 5.Those who were receiving corticosteroid, immunosuppressants, and chemotherapy drugs 6 months before enrollment. 6. Alcoholic liver disease, autoimmune liver disease and other liver diseases. 7. BMI > 28kg/m^2; 8. HBV drug-resistant patients; 9. Other conditions that the researchers consider unsuitable for enrollment; 10.In this study, first-line physicians determined patients' suitability for NAS and interferon therapy

Design outcomes

Primary

MeasureTime frame
Quantification of hepatitis B surface antigen;

Secondary

MeasureTime frame
Quantification of hepatitis B virus;Hepatitis B e antigen;

Countries

China

Contacts

Public ContactZhang Ka

The Third Affiliated Hospital Sun Yat-sen University

zhangka2@mail.sysu.edu.cn+86 20 8525 3571

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026