Clinical observation of recombinant cytokine gene derived protein injection in the treatment of HBeAg positive chronic hepatitis B

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2000040860

Enrollment

Unknown

Registered

2020-12-12

Start date

2020-12-31

Completion date

Unknown

Last updated

2021-04-12

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

Conditions

HBeAg positive Chronic Hepatitis B

Interventions

Treatment naive patients group:recombinant cytokine gene derived protein injection+nucleoside analogs

Treatment experienced group:recombinant cytokine gene derived protein injection+nucleoside analogs

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Cohort 1: Treatment naive patients group Inclusion criteria: 1. Patients with chronic hepatitis B who voluntarily participate in the clinical observational study and sign informed consent. 2. Diagnosis of patients with chronic hepatitis B in accordance with the Chinese guidelines for prevention and treatment of chronic hepatitis B (2019). 3. HBeAg was positive for more than 6 months and was not treated with nucleoside analogues. 4. The age ranged from 18 to 60 years old. Cohort 2: Treatment experienced patients group 1. Patients with chronic hepatitis B who voluntarily participate in the clinical observational study and sign informed consent. 2. Diagnosis of patients with chronic hepatitis B in accordance with the Chinese guidelines for prevention and treatment of chronic hepatitis B (2019). 3. Patients with HBeAg positive for more than 6 months received nucleoside (acid) analogues for more than one year. 4. The age is 18-60 years old.

Exclusion criteria

Exclusion criteria: 1. People with serious heart disease. 2. Severe liver, kidney, or bone marrow dysfunction. 3. Epilepsy and central nervous system dysfunction. 4. Patients with mental history or family history of psychosis. 5. Allergic to this product and its ingredients. 6. According to the medical history, patients with hepatitis C, autoimmune hepatitis, and other organ systemic diseases. 7. Pregnant or lactating women. 8. There were other abnormal conditions which were not included in the exclusion criteria, but the researchers considered that they should not be included in this study.

Design outcomes

Primary

Measure	Time frame
HBeAg quantification;HBsAg quantification;HBV DNA quantification;	—

Secondary

Measure	Time frame
ALT;CK;	—

Countries

China

Contacts

Public ContactXun Qihuan

The Third Affiliated Hospital of Sun Yat-Sen University

xqh032014@163.com+86 13724037332

Outcome results

None listed

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