Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients

NCT05490836 | Unknown

• 1 other identifier: KY2022-517
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is aimed to explore the safety and efficacy of the pulse usage , comparing to continuous usage, of Peginterferon alfa-2b Injection (PEG IFN α-2b) Combined With tenofovir alafenamide (TAF) in treatment of naive chronic hepatitis B patients with HBeAg negative.

Conditions

Chronic Hepatitis B

Keywords

Peg-IFN; Chronic hepatitis B; Functional cure rate

Outcome Measures

Primary Outcomes (1)

• The rate of HBsAg negative

  week 48

Secondary Outcomes (4)

• change in HBsAg level from baseline

  week 48

• The Rate of HBsAg seroconversion

  week 48

• Proportion of patients with HBV DNA Below the detection limit

  week 24 and week 48

• Number of patients with treatment-related adverse events

  from baseline to week 48

Study Arms (2)

continuous treatment arm

ACTIVE COMPARATOR

Biological: PEG IFN α-2b; TAF

pulse treatment arm

EXPERIMENTAL

Biological: PEG IFN α-2b; TAF

Interventions

PEG IFN α-2b; TAF BIOLOGICAL

TAF was orally administered once a day, and PEG IFN α-2b was subcutaneously injected 135 μg or 180μg once a week. treatment continuous for 48 weeks.

continuous treatment arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 65,included.
• HBsAg positive, HBeAg negative, anti HBE antibody positive, HBV-DNA ≥ 2x10\^3 IU/ml, ALT is continuously or repeatedly abnormal, or there is definite inflammation, necrosis and / or fibrosis (≥ G2/S2) confirmed in liver biopsy.
• Received no antiviral treatment previously.
• pregnancy test of Female subjects of childbearing must be negative before the enrollment, and all potential subjects must agree to take effective contraceptive measures during the treatment period and within half a year after the end of the treatment.
• Understand and sign the informed consent voluntarily.

You may not qualify if:

• Known allergy to interferon, nucleos(t)ide drugs, or any ingredient of the drug.
• Currently co-infection with HAV, HCV, HDV, HEV, HIV, or any other virus.
• Cirrhosis or Child-Pugh score of 7 or above.
• Liver disease caused by other reasons (eg. autoimmune liver disease, alcoholic liver disease, nonalcoholic fatty liver disease, drug-induced hepatitis, hepatolenticular degeneration, etc.).
• Pregnant or lactating women.
• Alcoholism or drug abuse within one year prior to the screening.
• Neutrophil count\<1.5×10\^9/L, hemoglobin\<100g/L, or platelet count\<80×10\^9/L.
• Serum creatinine was higher than the upper limit of normal at screening.
• History of serious disease in heart, brain, kidney, retina, muscle, or other major organ and systems.
• Have a history of mental illness or family history of mental illness, or Hamilton Depression Scale score ≥ 7 points.
• Have a history of endocrine system or autoimmune diseases, such as thyroid disease, systemic lupus erythematosus, sarcoidosis, autoimmune thrombocytopenic purpura, psoriasis, etc.
• Chronic diseases requiring long-term treatment, such as uncontrolled hypertension, diabetes, chronic obstructive pulmonary disease, etc.
• Malignant tumor.
• Suspected hepatocellular carcinoma in B-ultrasound at screening; or fetoprotein alpha was greater than 100ng/ml, or cannot remain stable within 3 months before screening.
• Accepted organ transplantation previously.

Sponsors & Collaborators

• Huashan Hospital: lead

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Professor

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 8, 2022
• Study Start: September 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 8, 2022

Record last verified: 2022-08