Back to resultsFunctional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients
Primary Purpose
Chronic Hepatitis B
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PEG IFN α-2b; TAF
PEG IFN α-2b; TAF
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Peg-IFN, Chronic hepatitis B, Functional cure rate
Eligibility Criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
- Other reasons that the investigator considers unsuitable for inclusion.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
continuous treatment arm
pulse treatment arm
Arm Description
Outcomes
Primary Outcome Measures
The rate of HBsAg negative
Secondary Outcome Measures
change in HBsAg level from baseline
The Rate of HBsAg seroconversion
Proportion of patients with HBV DNA Below the detection limit
Number of patients with treatment-related adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05490836
Brief Title
Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients
Official Title
Peginterferon Alfa-2b Combined With Tenofovir Alafenamide Improves the Functional Cure Rate in Patients With HBeAg Negative Chronic Hepatitis B: an Open-labeled, Multicenter, Randomized and Controlled Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Using antiviral drugs with different mechanisms of action is one of the effective means to improve the therapeutic outcome at present. At the same time, PEG-IFN is currently recognized as the only drug that can improve the functional cure rate of chronic hepatitis B, and PEG-IFN clinical application is limited due to adverse reactions. Exploring ways to reduce adverse reactions of PEG-IFN and improve PEG-IFN curative effects is the hot spot topic but also difficult at present.
Previously clinical practice have found that the temporary withdrawal of interferon have little influences on the whole clinical outcome in patients withdrawal of interferon due to adverse reactions, and there is indeed a continuous effect after the withdrawal of PEG-IFN for a certain period of time. Therefore, it is conceive that pulse usage of PEG-IFN (eg. use for 8 weeks followed by 4 weeks off) may be a effective method to reduce PEG-IFN adverse reactions while ensuring efficacy.
By comparing the safety and efficacy of pulsed and continuous combination therapy of Peg-IFNα-2b with TAF and in treatment naive HBeAg-negative CHB patients, the investigators hope to develop a better treatment plan for chronic hepatitis B.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Peg-IFN, Chronic hepatitis B, Functional cure rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
continuous treatment arm
Arm Type
Active Comparator
Arm Title
pulse treatment arm
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
PEG IFN α-2b; TAF
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
PEG IFN α-2b; TAF
Intervention Description
TAF was orally administered once a day, and PEG IFN α-2b was subcutaneously injected 135 μg or 180μg once a week for 8 weeks and followed by 4 weeks off. treatment continuous for 48 weeks.
Primary Outcome Measure Information:
Title
The rate of HBsAg negative
Time Frame
week 48
Secondary Outcome Measure Information:
Title
change in HBsAg level from baseline
Time Frame
week 48
Title
The Rate of HBsAg seroconversion
Time Frame
week 48
Title
Proportion of patients with HBV DNA Below the detection limit
Time Frame
week 24 and week 48
Title
Number of patients with treatment-related adverse events
Time Frame
from baseline to week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Other reasons that the investigator considers unsuitable for inclusion.
12. IPD Sharing Statement
Learn more about this trial
Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients
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