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RECRUITINGEARLY_PHASE1

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

A Multicenter, Prospective Cohort Study: Efficacy of NA Combined With PEG-IFN-α2b Continuous Versus Pulsed Therapy for 96 Weeks in Patients With Chronic Hepatitis B.

NCT05922306•Anhui Medical University

View on ClinicalTrials.gov

Summary

Previous studies have shown that there are alterations in the number and affinity of interferon receptors during interferon therapy and that such alterations recover to varying degrees some time after the end of treatment. It can be conjectured that the rest period of pulsed therapy facilitates the recovery of type I interferon receptors and thus the next round of IFN therapy compared to a continuous regimen of interferon.

Detailed Description

A large-sample, multicenter, prospective, real-world study using NAs in combination with PEG-IFN-α-2b for the treatment of CHB patients with continuous or pulsed combination therapy over a course of up to 96 weeks is proposed to compare the differences in clinical cure rates and E antigen conversion rates between groups. Multiple novel markers of hepatitis B infection, including HBV pgRNA, HBcrAg and anti-HBcAb quantification, were dynamically measured at baseline, 12, 24, 48, 72 and 96 weeks to explore the appropriate strategy for achieving clinical cure rates in CHB patients treated with NAs in combination with PEG-IFN-α-2b.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 to 60 years, both sexes (both 18 and 60 years)
•2. HBsAg positive for more than 6 months;
•3. NAs treated patients on continuous NA therapy for more than 6 months with HBsAg ≥ 1500 IU/ml and HBV-DNA \< 500 IU/ml at enrolment;
•4. Primary treated patients with surface antigen \>1500 IU, unlimited E antigen and unlimited HBV DNA at enrolment, meeting the treatment indications of the 2019 edition of the guidelines for the prevention and treatment of chronic hepatitis B.
•5. negative urine or serum pregnancy test within 24 hours prior to the first dose (for women of childbearing age)

Exclusion Criteria

•1. Combined active hepatitis A, C, D, E and/or HIV infection;
•2. Patients who are on future and intend to continue to use tibivudine
•3. methaemoglobin greater than 100ng/ml at screening; or methaemoglobin that has not remained stable for 3 months prior to the trial and/or liver imaging suggestive of liver tumours;
•4. decompensated liver disease (Child-Pugh score ≥ 7), meaning that patients will be excluded if one of the following is met: prolonged prothrombin time ≥ 3 seconds, serum bilirubin \> 34umol/L, history of hepatic encephalopathy, history of oesophageal variceal bleeding, ascites;
•5. pregnant or lactating women or patients with planned pregnancy during the study period and unwilling to use contraception
•6. Neutrophil count \< 1.5 x 10\^9/L or platelet count \< 90 x 10\^9/L and creatinine \> 1.5 ULN
•7. History of severe psychiatric illness, especially depression. Major psychosis defined as major depressive disorder or psychosis, suicide attempts, hospitalisation for psychosis or incapacity for a period of time due to psychosis;
•8. history of immune-mediated disease (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally elevated levels of autoimmune antibodies
•9. Patients with severe combined diseases of the heart, lungs, kidneys, brain, blood and other vital organs, combined with other malignancies
•10. History of severe epilepsy or current treatment with anti-epileptic drugs. Unstable control of diabetes mellitus, hypertension, thyroid disease, etc. Patients with a history of severe retinopathy or as indicated by other evidence of retinopathy;
+3 more criteria

Locations (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Key Dates

Start Date

July 1, 2023

Primary Completion Date

June 1, 2027

Completion Date

December 1, 2027

Last Updated

June 28, 2023

Enrollment

1,084

ESTIMATED participants

Conditions

Hepatitis B, Chronic

Interventions

PEGylated recombinant human interferon alpha-2b injection

DRUG

PEGylated recombinant human interferon alpha-2b injection

DRUG

Contacts

Yufeng Gao, MD

CONTACT

13956938032 aygyf@anmu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Inclusion Criteria

Exclusion Criteria

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels

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