Real-world study of the efficacy and safety of Peg-IFN-a-2b in the treatment of patients with chronic hepatitis B overlapping hepatitis D virus infection

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400083914

Enrollment

Unknown

Registered

2024-05-07

Start date

2024-10-01

Completion date

Unknown

Last updated

2024-09-30

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

Conditions

Chronic hepatitis B overlapping hepatitis D virus infection

Interventions

Peg-IFN-a-2b (135ug or 180ug dose) combined with NAs:none

NAs therapy alone:none

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age 18 ~ 65 years old, male and female (including 18 and 65 years old); (2) HBsAg positive for 6 months or more; (3) Patients with Peg-IFN-a-2b recommended in accordance with the Chronic Hepatitis B Prevention and Control Guidelines (2022 edition); (4) Hepatitis D antibody test positive, HDV-RNA positive patients; (5) Willing and suitable to receive any of the following treatment options: Plan 1: Peg-IFN-a-2b (135ug or 180ug dose) combined with NAs, 200 patients were to be included; Plan 2: NAs therapy alone, 200 patients were to be included; (6) Urine or serum pregnancy test is negative within 24 hours before the first medication (only for women of childbearing age); (7) Not pregnant or willing to use effective contraception; Voluntary entry, able to understand and sign informed consent;

Exclusion criteria

Exclusion criteria: (1) Short-term pregnancy plans, a history of mental illness (such as schizophrenia or severe depression), uncontrolled epilepsy, decompensated cirrhosis, uncontrolled autoimmune diseases, and underlying diseases such as severe infections, retinal diseases, heart failure, and chronic obstructive pulmonary disease. (2) Combined with hepatitis A, C, E and/or HIV infection, or with other causes of chronic liver disease, such as alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease; (3) Malignant tumors, or any history of organ transplantation and existing functional grafts (other than corneal or hair transplants); (4) Persons who are allergic to Peg-IFN-a-2b, or who meet any contraindication in the instructions of the investigational drug product; (5) Subjects deemed unsuitable for this study by the researcher.

Design outcomes

Primary

Measure	Time frame
HBsAg clearance;Serum conversion rate of HBsAg;Serum conversion rate of HDV-RNA;	—

Secondary

Measure	Time frame
Adverse event rate;	—

Countries

China

Contacts

Public ContactLu Xiaobo

The First Affiliated Hospital of Xinjiang Medical University

xjykdluxiaobo@126.com+86 159 9917 6213

Outcome results

None listed

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