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Clinical efficacy of nucleoside (acid) analog mono/sequential pegylated interferon in the treatment of immune tolerant chronic HBV: A Bidirectional, Open Study of Clinical Efficacy in Immune-Resistant Patients with Chronic HBV Infection

Clinical efficacy of nucleoside (acid) analog mono/sequential pegylated interferon in the treatment of immune tolerant chronic HBV: A Bidirectional, Open Study of Clinical Efficacy in Immune-Resistant Patients with Chronic HBV Infection

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068565
Enrollment
Unknown
Registered
2023-02-23
Start date
2023-02-28
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

HBV

Interventions

NAs:entecavir (ETV)/tenofovir disoproxil fumarate (TDF)/tenofovir alafenamid fumarate (TAF)
NAs sequential/combined Peg IFN a:entecavir (ETV)/tenofovir disoproxil fumarate (TDF)/tenofovir alafenamid fumarate (TAF)sequential/combined Peg IFN a (180ug SC qw for weight ? 75kg, 135ug SC qw for <

Sponsors

Beijing Youan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age: ?18 years old, no gender; It meets the diagnostic criteria for chronic HBV infection established in the Guidelines for Prevention and Treatment of Chronic Hepatitis B in China (2019 edition). HBeAg positive, HBV DNA > 2×104IU/ml; ALT=1 x ULN (ULN 40U/L); The patient had not received prior antiviral therapy (including nucleoside analogues and interferon therapy); Liver biopsy has been performed in our hospital to confirm that the patient is in the immune tolerance period.

Exclusion criteria

Exclusion criteria: Cirrhosis of the liver. Diagnosis or suspected hepatocellular carcinoma; Patients with other viral infections, such as chronic hepatitis C, hepatitis A, hepatitis D and other heparotropic viruses; The patient had other liver diseases, such as liver malignancy, alcoholic liver disease, autoimmune liver disease, hemochromatosis, drug-induced hepatitis, and hepatolenticular degeneration

Design outcomes

Primary

MeasureTime frame
VR at week48;48-week HBeAg seroconversion;Decrease level of HBeAg in 48 weeks;

Countries

China

Contacts

Public ContactRenshan

Beijing Youan Hospital, Capital Medical University

13811361553@163.com+86 13811361553

Outcome results

None listed

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