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Effect of spleen aminopeptide oral solution combined with Entecavir on HBeAg-positive chronic hepatitis B virus infection

Effect of spleen aminopeptide oral solution combined with Entecavir on HBeAg-positive chronic hepatitis B virus infection

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073098
Enrollment
Unknown
Registered
2023-06-30
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

Chronic hepatitis B

Interventions

Control group:Entecaciv Dispersible Tablets
Test group:Spleen Aminopeptide Oral Solution + Entecaciv Dispersible Tablets

Sponsors

The First Affiliated Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years old, male or female; 2. Clinical diagnosis of chronic hepatitis B virus infection HBsAg positive for more than six months, HBeAg positive; 3. Volunteer and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with decompensated cirrhosis (Child grades B and C); 2. Patients with liver cancer; 3. Patients who have received relevant antiviral or reduced-enzyme therapy in the last 3 months; 4. Patients who had used interferon in the past 6 months; 5. Patients simultaneously taking hormones or immune agents or chemotherapy drugs; 6. Female patients during pregnancy or pregnancy; 7. Patients who are unable to comply with the study protocol, or who have other conditions that the investigator deems unsuitable for inclusion; 8. Patients allergic to the investigational drug.

Design outcomes

Primary

MeasureTime frame
Effect on T cell subsets in peripheral blood of patients receiving experimental group;

Secondary

MeasureTime frame
HBV DNA Roche test showed that HBV DNA complete response rate was IU/ML;Rate and level of HBV RNA decline between the two groups;Glutamic oxalacetic transaminase and glutamic pyruvic transaminase decreased levels between the two groups;Differences in quantitative changes of hepatitis B surface antigen before and after treatment between the two groups;The difference of liver hardness between the two groups before and after treatment;Differences in cytokine changes before and after treatment between the two groups;

Countries

China

Contacts

Public ContactDeng Baocheng

The First Affiliated Hospital of China Medical University

sydengbc@163.com+86 138 8912 0840

Outcome results

None listed

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