Chronic Hepatitis BNCT05490836
Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients
A study testing PEG IFN α-2b; TAF in people with Chronic Hepatitis B, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- PEG IFN α-2b; TAF
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200081
About this study
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
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.
Read the 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.
- Conditions
- Chronic Hepatitis B
- Being tested
- PEG IFN α-2b; TAF
- Keywords
- Peg-IFN, Chronic hepatitis B, Functional cure rate
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG IFN α-2b; TAFBiological
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.
PEG IFN α-2b; TAFBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| continuous treatment arm | Active comparator | Not described Receives: Biological: PEG IFN α-2b; TAF |
| pulse treatment arm | Experimental | Not described Receives: Biological: PEG IFN α-2b; TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of HBsAg negative
Measured: week 48
Secondary outcomes (4)
change in HBsAg level from baseline
Measured: week 48
The Rate of HBsAg seroconversion
Measured: week 48
Proportion of patients with HBV DNA Below the detection limit
Measured: week 24 and week 48
Number of patients with treatment-related adverse events
Measured: from baseline to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Sep 2022
- Primary completion1 May 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiming Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490836
- Sponsor's protocol ID
- KY2022-517
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05490836
- Acronym / sponsor ID
- KY2022-517
- Conditions
- Chronic Hepatitis B
- Keywords
- Peg-IFN, Chronic hepatitis B, Functional cure rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous treatment arm | Active comparator | Biological: PEG IFN α-2b; TAF |
| pulse treatment arm | Experimental | Biological: PEG IFN α-2b; TAF |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG IFN α-2b; TAFTAF 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. | Biological | continuous treatment arm |
| PEG IFN α-2b; TAFTAF 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. | Biological | pulse treatment arm |
Primary outcome
The rate of HBsAg negative
Time frame: week 48
4 secondary outcomes
change in HBsAg level from baseline
Time frame: week 48
The Rate of HBsAg seroconversion
Time frame: week 48
Proportion of patients with HBV DNA Below the detection limit
Time frame: week 24 and week 48
Number of patients with treatment-related adverse events
Time frame: from baseline to week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG IFN α-2b; TAF in people with Chronic Hepatitis B, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of HBsAg negative (time frame: week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.