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Multicenter real-world study on high-resistance barrier nucleoside analogues for chronic hepatitis B in China

Multicenter real-world study on high-resistance barrier nucleoside analogues for chronic hepatitis B in China (Puzhong Engineering/Care-B Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121231
Enrollment
Unknown
Registered
2026-03-27
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Chronic hepatitis B

Interventions

High drug resistance barrier NAs treatment group:None

Sponsors

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 65 years (inclusive), irrespective of gender; 2.Meeting the diagnostic criteria for chronic hepatitis B (CHB); 3.Fulfilling the indications for antiviral therapy as outlined in the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 edition); 4.The most recent HBV DNA test result indicates HBV DNA > 20 IU/mL, or above the lower limit of detection of the local PCR assay, or an adjustment in treatment strategy following physician-patient communication; 5.Currently receiving one or two oral nucleos(t)ide analogues (NAs) with a high resistance barrier, or being treatment-naive for CHB; 6.Awareness of the study content and voluntary participation;

Exclusion criteria

Exclusion criteria: 1.Evidence suggestive of hepatocellular carcinoma (HCC), or serum alpha-fetoprotein (AFP) level > 100 µg/L, or decompensated cirrhosis; 2.History of hypersensitivity to nucleos(t)ide analogues (NAs); 3.Concurrent severe cardiac or pulmonary dysfunction, advanced malignancy, central nervous system disorders (e.g., history of epilepsy), or other systemic diseases that would compromise the ability to complete the 5-year follow-up; or presence of neurological or psychiatric conditions that would hinder cooperation; 4.Considered by the investigator to be unsuitable for participation in this clinical study;

Design outcomes

Primary

MeasureTime frame
Complete Virological Response Rate;—

Secondary

MeasureTime frame
Liver Function-Associated Parameters;CHB Virological Markers;Liver Fibrosis-Associated Indices;Hepatocellular Carcinoma (HCC)-Associated Markers;Safety Endpoints;—

Countries

China

Contacts

Public ContactNing Qin

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology

qning@vip.sina.com+86 27 83662391

Outcome results

None listed

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