Hepatitis B, ChronicNCT06923280
Sequential PEG-IFN for HBV After Ending RNA-targeted Regimens
A study testing Pegylated Interferon-alpha (IFN) in people with Hepatitis B, Chronic, run by Huashan Hospital at 2 sites in China.
Trial summary
The goal of this clinical trial is to compare sequential PEG-IFNα therapy strategies in chronic hepatitis B (CHB) patients previously treated with ASO/siRNA. The main questions it aims to answer are: 1. Does sequential PEG-IFNα therapy (vs. deferred/no treatment) improve HBsAg clearance rates? 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Pegylated Interferon-alpha (IFN)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesChina
- Study dates
- 25 Aug 2025to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Chronic HBV infection (documented HBsAg positivity for >6 months).
- Prior participation in ASO or siRNA clinical trials:
- Received ≥1 dose of ASO/siRNA (or matched placebo, if applicable).
- Achieved ≥1 log10 IU/mL HBsAg decline from baseline during prior therapy.
- Discontinued ASO/siRNA therapy before screening.
Show all 11Show fewer
- Screening HBsAg: 1-500 IU/mL.
- No prior interferon (IFN) therapy within 6 months before enrollment.
- Willingness to comply with study-related treatments, tests, and procedures.
- Commitment to contraception during the study.
- Voluntary participation with signed informed consent.
Who cannot join
- Decompensated cirrhosis or hepatic malignancy (evidenced by imaging or histology within 6 months before/during screening).
- Elevated AFP: Screening AFP >100 ng/mL; AFP 20-100 ng/mL with imaging-confirmed hepatocellular carcinoma (ultrasound/CT/MRI).
- Coinfection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV), or human immunodeficiency virus (HIV).
- Recent immunomodulatory therapy: Systemic corticosteroids, thymosin, or other potent immunomodulators for >2 weeks within 6 months before enrollment.
- Pregnancy, lactation, or plans for pregnancy during the study.
- Autoimmune hepatitis.
Show all 18Show fewer
- Active autoimmune diseases (e.g., psoriasis, systemic lupus erythematosus).
- Uncontrolled cardiovascular disease (e.g., unstable angina, myocardial infarction within 6 months).
- Poorly controlled endocrine disorders (e.g., diabetes mellitus, thyroid dysfunction).
- Severe psychiatric disorders: History of depression, anxiety, bipolar disorder, schizophrenia, or family history of psychiatric conditions (especially depression).
- Substance abuse: Alcohol (>40 g/day for males; >20 g/day for females) or Illicit drug use.
- Severe retinopathy or ophthalmologic disorders.
- Renal diseases: Chronic nephritis, renal insufficiency, nephrotic syndrome.
- Major organ dysfunction (e.g., heart, lung, pancreas).
- Organ transplant recipients or candidates.
- Hypersensitivity to interferon or excipients.
- Concurrent participation in other HBV-related interventional trials.
- Other conditions deemed unsuitable by investigators (e.g., non-compliance risk).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Ditan Hospital
Beijing, China
Yao Xie, Professor, 86-13501093293, xieyao00120184@sina.com
- Recruiting
Huashan Hospita
Shanghai, China
Wenhong Zhang, Professor, 13801844344, zhangwenhong@fudan.edu.cn
Feng Sun, Doctor, aaronsf1125@126.com
About this study
Official title: Efficacy and Safety of Pegylated Interferon Therapy in Chronic Hepatitis B Patients After Discontinuation of Antisense Oligonucleotide or Small Interfering RNA: A Prospective, Adaptive, Open-label, Randomized Controlled Study
The goal of this clinical trial is to compare sequential PEG-IFNα therapy strategies in chronic hepatitis B (CHB) patients previously treated with ASO/siRNA. The main questions it aims to answer are:
- Does sequential PEG-IFNα therapy (vs. deferred/no treatment) improve HBsAg clearance rates?
- What are the HBsAg clearance and relapse rates after 24 weeks of PEG-IFNα therapy?
- Is intermittent PEG-IFNα therapy as effective and safe as continuous therapy?
Read more
Researchers will compare:
- Group A (immediate 24-week PEG-IFNα + 24-week follow-up) vs. Group B (24-week observation + 24-week PEG-IFNα) in Phase 1 to see if sequential PEG-IFNα therapy will improve HBsAg loss rate .
Researchers will describe:
- The response rate of IFN treatment in non-responders (HBsAg-positive) in Phase 2.
- The relaspe rate of responders (HBsAg-negative).
Participants will:
Phase 1 (0-48 weeks):
- Group A: Receive PEG-IFNα for 24 weeks, followed by 24-week treatment-free follow-up.
- Group B: Undergo 24-week observation, then receive PEG-IFNα for 24 weeks.
Phase 2 (48-96 weeks):
- HBsAg-positive at week 48 patients either from group A or group B : Receive 24-week PEG-IFNα therapy, followed by 24-week follow-up.
- HBsAg-negative at week 48 patients either from group A or group B: Enter 24-week follow-up without treatment.
All participants will undergo:
- HBsAg quantification, HBV DNA, liver function, and safety monitoring (every 12 weeks).
- Conditions
- Hepatitis B, Chronic
- Being tested
- Pegylated Interferon-alpha (IFN)
- 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.
Pegylated Interferon-alpha (IFN)Drug
pegylated interferon-alpha 180 μg once weekly for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| A：Immediate PEG-IFNα Induction | Experimental | Receive PEG-IFNα for 24 weeks, followed by 24-week treatment-free follow-up Receives: Drug: Pegylated Interferon-alpha (IFN) |
| B: Deferred PEG-IFNα Initiation | Experimental | Undergo 24-week observation, then receive PEG-IFNα for 24 weeks Receives: Drug: Pegylated Interferon-alpha (IFN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV DNA and HBsAg undetectable with/without anti-HBs
Proportion of patients achieving HBV DNA below the lower limit of quantification (LLOQ; <20 IU/mL), HBsAg undetectable (<0.05 IU/mL) (with or without anti-HBs seroconversion), and normal liver biochemical indices at Week 72.
Measured: week 72
Secondary outcomes (16)
HBV DNA and HBsAg undetectable with/without anti-HBs during the study
Proportion of patients achieving HBV DNA <20 IU/mL, HBsAg <0.05 IU/mL (with or without anti-HBs), and normal liver biochemistry at Weeks 24, 48, and 96.
Measured: Weeks 24, 48, and 96
HBV DNA and HBsAg undetectable during the study
Proportion of patients achieving HBsAg <0.05 IU/mL and HBV DNA <20 IU/mL at Weeks 24, 48, 72, and 96.
Measured: Weeks 24, 48, 72, and 96
HBsAg level
HBsAg levels in each group at Weeks 24, 48, 72, and 96
Measured: Weeks 24, 48, 72, and 96
HBsAg decline from baseline
Magnitude of HBsAg decline from baseline in each group at Weeks 24, 48, 72, and 96
Measured: Weeks 24, 48, 72, and 96
HBsAg seroclearance
HBsAg seroclearance rate (HBsAg <0.05 IU/mL) in each group at Weeks 24, 48, 72, and 96
Measured: Weeks 24, 48, 72, and 96
HBsAg seroconversion
HBsAg seroconversion rate (anti-HBs ≥10 mIU/mL) in each group at Weeks 24, 48, 72, and 96
Measured: Weeks 24, 48, 72, and 96
HBeAg seroclearance
HBeAg seroclearance rate in baseline HBeAg-positive patients at Weeks 24, 48, 72, and 96
Measured: Weeks 24, 48, 72, and 96
HBeAg seroconversion
HBeAg seroconversion rate (anti-HBe positivity) in baseline HBeAg-positive patients at Weeks 24, 48, 72, and 96
Measured: Weeks 24, 48, 72, and 96
HBV DNA level
HBV DNA levels in each group at Weeks 24, 48, 72, and 96
Measured: Weeks 24, 48, 72, and 96
HBV DNA decline from baseline
Magnitude of HBV DNA decline from baseline in each group at Weeks 24, 48, 72, and 96
Measured: Weeks 24, 48, 72, and 96
HBV DNA undetectabe
HBV DNA undetectability rate (<20 IU/mL) in baseline HBV DNA-positive patients at Weeks 24, 48, 72, and 96
Measured: Weeks 24, 48, 72, and 96
ALT levels
ALT levels in each group at Weeks 24, 48, 72, and 96
Measured: Weeks 24, 48, 72, and 96
ALT normalization
ALT normalization rate (≤upper limit of normal [ULN]) in each group at Weeks 24, 48, 72, and 96
Measured: Weeks 24, 48, 72, and 96
ALT levels from baseline
Change in ALT levels from baseline in each group at Weeks 24, 48, 72, and 96
Measured: Weeks 24, 48, 72, and 96
saftey
Incidence of adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs) during the study, including findings from Physical examinations, Laboratory tests, Hematology, Urinalysis, Blood biochemistry, Coagulation profile
Measured: Weeks 24, 48, 72, and 96
Percentage of patients who achieved functional cure
sustained undetectable HBV DNA and HBsAg loss for at least 24 weeks off Peg-IFNα treatment
Measured: 24 weeks off Peg-IFNα treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start25 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B, ChronicStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
- Investigators
- Wenghong Zhang, MD, Principal investigator, Huashan HospitalJiming Zhang, MD, Principal investigator, Huashan HospitalYuxian Huang, MD, Principal investigator, Huashan HospitalFeng Sun, MD, Study chair, Huashan HospitalChao Qiu, Principal investigator, Huashan HospitalChen Chen, MD, Study director, Huashan HospitalQiran Zhang, MD, Study director, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923280
- Sponsor's protocol ID
- SPHERE
- Status last verified
- Jul 2026
- First submitted
- 3 Apr 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ning Q, Han M, Sun Y, Jiang J, Tan D, Hou J, Tang H, Sheng J, Zhao M. Switching from entecavir to PegIFN alfa-2a in patients with HBeAg-positive chronic hepatitis B: a randomised open-label trial (OSST trial). J Hepatol. 2014 Oct;61(4):777-84. doi: 10.1016/j.jhep.2014.05.044. Epub 2014 Jun 7.
PubMed 24915612Yuen MF, Lim YS, Yoon KT, Lim TH, Heo J, Tangkijvanich P, Tak WY, Thanawala V, Cloutier D, Mao S, Arizpe A, Cathcart AL, Gupta SV, Hwang C, Gane E. VIR-2218 (elebsiran) plus pegylated interferon-alfa-2a in participants with chronic hepatitis B virus infection: a phase 2 study. Lancet Gastroenterol Hepatol. 2024 Dec;9(12):1121-1132. doi: 10.1016/S2468-1253(24)00237-1. Epub 2024 Oct 8.
PubMed 39389081Mak LY, Wooddell CI, Lenz O, Schluep T, Hamilton J, Davis HL, Mao X, Seto WK, Biermer M, Yuen MF. Long-term hepatitis B surface antigen response after finite treatment of ARC-520 or JNJ-3989. Gut. 2025 Feb 6;74(3):440-450. doi: 10.1136/gutjnl-2024-333026.
PubMed 39266050Buti M, Heo J, Tanaka Y, Andreone P, Atsukawa M, Cabezas J, Chak E, Coffin CS, Fujiwara K, Gankina N, Gordon SC, Janczewska E, Komori A, Lampertico P, McPherson S, Morozov V, Plesniak R, Poulin S, Ryan P, Sagalova O, Sheng G, Voloshina N, Xie Q, Yim HJ, Dixon S, Paff M, Felton L, Lee M, Greene T, Lim J, Lakshminarayanan D, McGonagle G, Plein H, Youssef AS, Elston R, Kendrick S, Theodore D. Sequential Peg-IFN after bepirovirsen may reduce post-treatment relapse in chronic hepatitis B. J Hepatol. 2025 Feb;82(2):222-234. doi: 10.1016/j.jhep.2024.08.010. Epub 2024 Aug 29.
PubMed 39214467Yuen MF, Lim SG, Plesniak R, Tsuji K, Janssen HLA, Pojoga C, Gadano A, Popescu CP, Stepanova T, Asselah T, Diaconescu G, Yim HJ, Heo J, Janczewska E, Wong A, Idriz N, Imamura M, Rizzardini G, Takaguchi K, Andreone P, Arbune M, Hou J, Park SJ, Vata A, Cremer J, Elston R, Lukic T, Quinn G, Maynard L, Kendrick S, Plein H, Campbell F, Paff M, Theodore D; B-Clear Study Group. Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B Infection. N Engl J Med. 2022 Nov 24;387(21):1957-1968. doi: 10.1056/NEJMoa2210027. Epub 2022 Nov 8.
PubMed 36346079Zhang Q, Sun F, Sui S, Lin J, Wu C, Yuan J, He Y, Shang J, Han T, Zhu Y, Huang Z, Chen C, Qiu C, Wang X, Zhang J, Xie Y, Zhang W. Efficacy and Safety of Pegylated Interferon as Rescue Therapy for Patients with Chronic Hepatitis B Who Failed to Achieve Functional Cure After Antisense Oligonucleotides or Small Interfering RNA: A Prospective, Multicentre, Open-Label Randomized Controlled Trial (SPHERE) Protocol. Adv Ther. 2026 Aug;43(8):3660-3673. doi: 10.1007/s12325-026-03633-0. Epub 2026 May 23.
PubMed 42176181
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pegylated Interferon Therapy in Chronic Hepatitis B Patients After Discontinuation of Antisense Oligonucleotide or Small Interfering RNA: A Prospective, Adaptive, Open-label, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06923280
- Acronym / sponsor ID
- SPHERE
- Conditions
- Hepatitis B, Chronic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 11 Apr 2025 (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 goal of this clinical trial is to compare sequential PEG-IFNα therapy strategies in chronic hepatitis B (CHB) patients previously treated with ASO/siRNA. The main questions it aims to answer are:
- Does sequential PEG-IFNα therapy (vs. deferred/no treatment) improve HBsAg clearance rates?
- What are the HBsAg clearance and relapse rates after 24 weeks of PEG-IFNα therapy?
- Is intermittent PEG-IFNα therapy as effective and safe as continuous therapy?
Researchers will compare:
- Group A (immediate 24-week PEG-IFNα + 24-week follow-up) vs. Group B (24-week observation + 24-week PEG-IFNα) in Phase 1 to see if sequential PEG-IFNα therapy will improve HBsAg loss rate .
Researchers will describe:
- The response rate of IFN treatment in non-responders (HBsAg-positive) in Phase 2.
- The relaspe rate of responders (HBsAg-negative).
Participants will:
Phase 1 (0-48 weeks):
- Group A: Receive PEG-IFNα for 24 weeks, followed by 24-week treatment-free follow-up.
- Group B: Undergo 24-week observation, then receive PEG-IFNα for 24 weeks.
Phase 2 (48-96 weeks):
- HBsAg-positive at week 48 patients either from group A or group B : Receive 24-week PEG-IFNα therapy, followed by 24-week follow-up.
- HBsAg-negative at week 48 patients either from group A or group B: Enter 24-week follow-up without treatment.
All participants will undergo:
- HBsAg quantification, HBV DNA, liver function, and safety monitoring (every 12 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A：Immediate PEG-IFNα Induction | Experimental | Drug: Pegylated Interferon-alpha (IFN)Receive PEG-IFNα for 24 weeks, followed by 24-week treatment-free follow-up |
| B: Deferred PEG-IFNα Initiation | Experimental | Drug: Pegylated Interferon-alpha (IFN)Undergo 24-week observation, then receive PEG-IFNα for 24 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years.
- Chronic HBV infection (documented HBsAg positivity for >6 months).
- Prior participation in ASO or siRNA clinical trials:
- Received ≥1 dose of ASO/siRNA (or matched placebo, if applicable).
- Achieved ≥1 log10 IU/mL HBsAg decline from baseline during prior therapy.
Key exclusion criteria (18 listed)
- Decompensated cirrhosis or hepatic malignancy (evidenced by imaging or histology within 6 months before/during screening).
- Elevated AFP: Screening AFP >100 ng/mL; AFP 20-100 ng/mL with imaging-confirmed hepatocellular carcinoma (ultrasound/CT/MRI).
- Coinfection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV), or human immunodeficiency virus (HIV).
- Recent immunomodulatory therapy: Systemic corticosteroids, thymosin, or other potent immunomodulators for >2 weeks within 6 months before enrollment.
- Pregnancy, lactation, or plans for pregnancy during the study.
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 |
|---|---|---|
| Pegylated Interferon-alpha (IFN)pegylated interferon-alpha 180 μg once weekly for 24 weeks | Drug | A：Immediate PEG-IFNα Induction, B: Deferred PEG-IFNα Initiation |
Primary outcome
HBV DNA and HBsAg undetectable with/without anti-HBs
Time frame: week 72
Proportion of patients achieving HBV DNA below the lower limit of quantification (LLOQ; <20 IU/mL), HBsAg undetectable (<0.05 IU/mL) (with or without anti-HBs seroconversion), and normal liver biochemical indices at Week 72.
16 secondary outcomes
HBV DNA and HBsAg undetectable with/without anti-HBs during the study
Time frame: Weeks 24, 48, and 96
HBV DNA and HBsAg undetectable during the study
Time frame: Weeks 24, 48, 72, and 96
HBsAg level
Time frame: Weeks 24, 48, 72, and 96
HBsAg decline from baseline
Time frame: Weeks 24, 48, 72, and 96
HBsAg seroclearance
Time frame: Weeks 24, 48, 72, and 96
HBsAg seroconversion
Time frame: Weeks 24, 48, 72, and 96
HBeAg seroclearance
Time frame: Weeks 24, 48, 72, and 96
HBeAg seroconversion
Time frame: Weeks 24, 48, 72, and 96
HBV DNA level
Time frame: Weeks 24, 48, 72, and 96
HBV DNA decline from baseline
Time frame: Weeks 24, 48, 72, and 96
HBV DNA undetectabe
Time frame: Weeks 24, 48, 72, and 96
ALT levels
Time frame: Weeks 24, 48, 72, and 96
ALT normalization
Time frame: Weeks 24, 48, 72, and 96
ALT levels from baseline
Time frame: Weeks 24, 48, 72, and 96
saftey
Time frame: Weeks 24, 48, 72, and 96
Percentage of patients who achieved functional cure
Time frame: 24 weeks off Peg-IFNα treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 24915612Ning Q, Han M, Sun Y, Jiang J, Tan D, Hou J, Tang H, Sheng J, Zhao M. Switching from entecavir to PegIFN alfa-2a in patients with HBeAg-positive chronic hepatitis B: a randomised open-label trial (OSST trial). J Hepatol. 2014 Oct;61(4):777-84. doi: 10.1016/j.jhep.2014.05.044. Epub 2014 Jun 7.
- Background: PubMed 39389081Yuen MF, Lim YS, Yoon KT, Lim TH, Heo J, Tangkijvanich P, Tak WY, Thanawala V, Cloutier D, Mao S, Arizpe A, Cathcart AL, Gupta SV, Hwang C, Gane E. VIR-2218 (elebsiran) plus pegylated interferon-alfa-2a in participants with chronic hepatitis B virus infection: a phase 2 study. Lancet Gastroenterol Hepatol. 2024 Dec;9(12):1121-1132. doi: 10.1016/S2468-1253(24)00237-1. Epub 2024 Oct 8.
- Background: PubMed 39266050Mak LY, Wooddell CI, Lenz O, Schluep T, Hamilton J, Davis HL, Mao X, Seto WK, Biermer M, Yuen MF. Long-term hepatitis B surface antigen response after finite treatment of ARC-520 or JNJ-3989. Gut. 2025 Feb 6;74(3):440-450. doi: 10.1136/gutjnl-2024-333026.
- Background: PubMed 39214467Buti M, Heo J, Tanaka Y, Andreone P, Atsukawa M, Cabezas J, Chak E, Coffin CS, Fujiwara K, Gankina N, Gordon SC, Janczewska E, Komori A, Lampertico P, McPherson S, Morozov V, Plesniak R, Poulin S, Ryan P, Sagalova O, Sheng G, Voloshina N, Xie Q, Yim HJ, Dixon S, Paff M, Felton L, Lee M, Greene T, Lim J, Lakshminarayanan D, McGonagle G, Plein H, Youssef AS, Elston R, Kendrick S, Theodore D. Sequential Peg-IFN after bepirovirsen may reduce post-treatment relapse in chronic hepatitis B. J Hepatol. 2025 Feb;82(2):222-234. doi: 10.1016/j.jhep.2024.08.010. Epub 2024 Aug 29.
- Background: PubMed 36346079Yuen MF, Lim SG, Plesniak R, Tsuji K, Janssen HLA, Pojoga C, Gadano A, Popescu CP, Stepanova T, Asselah T, Diaconescu G, Yim HJ, Heo J, Janczewska E, Wong A, Idriz N, Imamura M, Rizzardini G, Takaguchi K, Andreone P, Arbune M, Hou J, Park SJ, Vata A, Cremer J, Elston R, Lukic T, Quinn G, Maynard L, Kendrick S, Plein H, Campbell F, Paff M, Theodore D; B-Clear Study Group. Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B Infection. N Engl J Med. 2022 Nov 24;387(21):1957-1968. doi: 10.1056/NEJMoa2210027. Epub 2022 Nov 8.
- Derived from this study: PubMed 42176181Zhang Q, Sun F, Sui S, Lin J, Wu C, Yuan J, He Y, Shang J, Han T, Zhu Y, Huang Z, Chen C, Qiu C, Wang X, Zhang J, Xie Y, Zhang W. Efficacy and Safety of Pegylated Interferon as Rescue Therapy for Patients with Chronic Hepatitis B Who Failed to Achieve Functional Cure After Antisense Oligonucleotides or Small Interfering RNA: A Prospective, Multicentre, Open-Label Randomized Controlled Trial (SPHERE) Protocol. Adv Ther. 2026 Aug;43(8):3660-3673. doi: 10.1007/s12325-026-03633-0. Epub 2026 May 23.
Related trials for Hepatitis B, Chronic
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingPhase 4
B-Ensure: Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants
Hepatitis B
Active, not recruitingPhase 2
A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
Not yet recruitingPhase 1
Phase Ia/Ib Trial of SCTA02A Injection in Healthy Adults and Patients With Chronic Hepatitis B
Hepatitis B
Active, not recruitingPhase 1/2
A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
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.
Wenghong Zhang, MD principal investigator
Huashan Hospital
Jiming Zhang, MD principal investigator
Huashan Hospital
Yuxian Huang, MD principal investigator
Huashan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pegylated Interferon-alpha (IFN) in people with Hepatitis B, Chronic, run by Huashan Hospital at 2 sites 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 11 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenghong Zhang, MD (13801844344, zhangwenhong@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBV DNA and HBsAg undetectable with/without anti-HBs (time frame: week 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06923280, which also lists 6 linked publications.
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 29 Jul 2026.