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Analysis of viral transcriptional activity of chronic hepatitis B in different HBeAg infection states and prediction of drug withdrawal safety

Analysis of viral transcriptional activity of chronic hepatitis B in different HBeAg infection states and prediction of drug withdrawal safety

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200055418
Enrollment
Unknown
Registered
2022-01-09
Start date
2021-01-01
Completion date
Unknown
Last updated
2023-01-30

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

Conditions

Hepatitis B

Interventions

HBeAg + group vs. HBeAg - group:None

Sponsors

Dongzhimen Hospital, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. There is evidence that the diagnosis meets the diagnostic criteria of HBeAg negative and positive chronic hepatitis B, and those who routinely receive nucleoside (acid) analog antiviral therapy (entecavir); 2. Aged between 18-65 years; 3. Syndrome differentiation is a compound syndrome of ''liver stagnation and spleen deficiency, liver and gallbladder damp-heat''; 4. Voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Serological test confirmed chronic hepatitis caused by hepatitis virus superinfection, non-viral infection (such as alcoholic liver disease), or cryptogenic hepatitis; 2. Patients with liver failure, liver cirrhosis (fibrosis S4 and above), hepatic encephalopathy, water-electrolyte and acid-base balance disorders, gastrointestinal bleeding, infection and other serious complications of chronic hepatitis B; 3. Those with a confirmed tumor, or a history of malignant tumor, or a progressive increase in tumor markers; 4. Patients with primary and/or secondary cardiovascular and cerebrovascular, lung, kidney, endocrine, digestive system, nervous and blood system diseases; 5. Those who have participated in or are participating in other clinical trials within one month; 6. Patients with mental disorders who cannot express their own feelings; 7. Women who plan to become pregnant and men who plan to conceive; 8. There are other situations that are not suitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
TCM syndrome scale;HBV core-associated antigen;HBV surface large protein;HBV pregenomic RNA;

Countries

China

Contacts

Public ContactYe Yong'an
yeyongan@vip.163.com+86 15810051727

Outcome results

None listed

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