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A real-world study of long-acting interferon guided by ?HBsAg levels in the treatment of HBeAg-negative patients with chronic HBV infection

A real-world study of long-acting interferon guided by ?HBsAg levels in the treatment of HBeAg-negative patients with chronic HBV infection

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400082602
Enrollment
Unknown
Registered
2024-04-01
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-08

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

1:none
2:none

Sponsors

The First Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 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) The maximum quantitative titer of HBsAg was <5000IU/mL; (4) HBeAg negative chronic HBV infection; (5) Patients with long-acting interferon recommended in accordance with the Chronic Hepatitis B Prevention and Treatment Guidelines (2022 edition); (6) Willing and suitable to receive any of the following treatment options: Regimen 1: Long-acting interferon (Piagabin) monotherapy group (135ug or 180ug dose); Scheme 2: NAs drug group alone; Scheme 3: NAs combined with Pygabine initial treatment group; Plan 4: NAs combined with pergolbine sequential treatment group (NAs medication for at least six months); (7) Within 24 hours before the first medication, urine or serum pregnancy test is negative (only for women of childbearing age), and consent to the study; (8) Willing to take effective contraceptive measures during pregnancy or pregnancy; 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, D, 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 pygabine, or who meet any contraindication in the instruction manual of the experimental drug; (5) Subjects deemed unsuitable for this study by the researcher.

Design outcomes

Primary

MeasureTime frame
HBsAg clearance;Serum conversion rate of HBsAg;

Secondary

MeasureTime frame
Incidence of cirrhosis;Incidence of liver cancer;

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