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A prospective study to explore persistence after clinical cure of chronic hepatitis B

A prospective study to explore persistence after clinical cure of chronic hepatitis B

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400079938
Enrollment
Unknown
Registered
2024-01-16
Start date
2022-07-26
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Chronic viral hepatitis B

Interventions

Group of patients with clinically cured CHB (HBsAg< 0.05 IU/mL):None

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Participants must meet all of the following inclusion criteria to be enrolled in this study. 1. Aged between 18 (inclusive) and 65 (inclusive) years; 2. Patients with clinical cure of CHB after treatment with NAs or PEG-IFN: 1) Disappearance of HBsAg (< 0.05 IU/mL) (after at least 2 tests, 6 months or more apart); 2) HBV DNA negative (high precision, < 20 IU/mL); 3) HBeAg negative; 3. No contraindications to liver puncture, intention to liver puncture and understanding to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects with any of the following conditions are not eligible to participate in this study; 2. The subjects had a history of hepatic decompensation, or had ascites, gastrointestinal bleeding, hepatic encephalopathy, or spontaneous peritonitis; 3. The subjects had been diagnosed with hepatocellular carcinoma or had been indicated by relevant examinations, such as suspected HCC nodules on imaging, or obvious abnormalities of AFP and PIVKA-II; 4. Confirmed or suspected malignant tumors other than liver cancer; 5. Combined with HCV or HIV infection; 6. Subjects need to take immunosuppressants or glucocorticoids; 7. Patients with serious and important organ diseases other than hepatitis B, such as cardiovascular, pulmonary, renal, and brain diseases; 8. Patients with autoimmune diseases, psychosis, diabetes, and abnormal thyroid function. 9. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
cccDNA;HBV DNA;

Secondary

MeasureTime frame
HBV RNA;HBcrAg;HBsAg;

Countries

China

Contacts

Public ContactHong Tang

West China Hospital of Sichuan University

htang6178@163.com+86 189 8060 1313

Outcome results

None listed

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