Chronic Hepatitis BPhase 4NCT06900166
Pegylated Interferon Alfa-2b in Reducing Relapse Rates After Nucleos(t)ide Analogue Withdrawal in HBeAg-negative CHB Patients with Low Level HBsAg
A Phase 4 study testing PegIFN alfa-2b and PegIFN alfa-2b and NUC in people with Chronic Hepatitis B, run by Huashan Hospital at 1 site in China.
Trial summary
All enrolled patients must meet the European Guidelines for the Prevention and Treatment of Chronic Hepatitis B (EASL, 2017) recommended discontinuation criteria, that is, HBeAg-negative chronic hepatitis B patients without fibrosis or cirrhosis who have undetectable HBV DNA for more than 3 years after receiving NUC… 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?
- PegIFN alfa-2b and PegIFN alfa-2b and NUC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to Apr 2029
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 (inclusive), regardless of gender;
- Fibroscan ≤ 7.4kpa;
- HBeAg-negative CHB patients: HBsAg positive, HBeAg negative, HBsAb negative and HBeAb positive before receiving NUC treatment and during screening in this study;
- HBeAg-negative chronic hepatitis B patients without liver cirrhosis who have been viral-negative for more than 3 years after receiving NUC treatment, and they meet the 2017 EASL guideline discontinuation standard (HBV DNA is lower than the lower limit of detection, that is, <20 IU/ml);
- HBsAg≤1000 IU/ml;
- Have the intention to stop taking the drug, and sign a written informed consent.
Who cannot join
- HBsAb positive during screening;
- Patients with hepatitis B cirrhosis in the compensatory and decompensated stage: patients with a clear history of cirrhosis (imaging or histological evidence) or Child-Pugh score ≥5 before NUC treatment, or complications of cirrhosis in the decompensated stage such as ascites, hepatic encephalopathy, esophageal variceal hemorrhage, etc.;
- Patients who are allergic to alpha interferon and its drug ingredients, and the researchers judge that alpha interferon is not suitable for patients;
- Received immunomodulators (including interferon, etc.) within 1 year before screening;
- Combined with HAV, HCV, HDV, HEV, HIV infection, alcoholic liver disease, genetic metabolic liver disease, drug liver disease, non-alcoholic fatty liver disease and other chronic liver diseases;
- Combined with autoimmune diseases, including autoimmune liver disease, psoriasis, etc.
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- Patients with primary liver cancer or screening with AFP greater than 100 ng/ml and imaging findings indicating the possibility of malignant liver occupation; Or AFP greater than 100 ng/ml for 3 months;
- Neutrophil count < 1.5 x 109 cells /L or platelet count < 90 x 109 cells /L;
- Creatinine is 1.5 times higher than the upper limit of normal;
- Patients with other malignant tumors (excluding cured patients);
- Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs;
- Patients with severe neurological and psychiatric disorders (such as epilepsy, depression, mania, seizures, schizophrenia, etc.);
- Control unstable diabetes, hypertension, thyroid disease, etc.;
- Pregnant and lactating women or patients who had pregnancy plans during the study period and did not want to use contraception;
- Participate in other clinical investigators;
- Patients who were not considered suitable for participation in this study by the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jiming Zhang, M.D. contact
China1 site
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Fahong Li, Doctor, 13524212580, minelihong@163.com
About this study
Official title: A Prospective, Open-Label, Randomized, Controlled, Multicenter Clinical Study of Pegylated Interferon Alfa-2b in Reducing Relapse Rates After Nucleos(t)ide Analogue Withdrawal in HBeAg-Negative Chronic Hepatitis B Patients with Low-Level HBsAg
All enrolled patients must meet the European Guidelines for the Prevention and Treatment of Chronic Hepatitis B (EASL, 2017) recommended discontinuation criteria, that is, HBeAg-negative chronic hepatitis B patients without fibrosis or cirrhosis who have undetectable HBV DNA for more than 3 years after receiving NUC treatment can attempt to discontinue the drug. At the same time, the patient's HBsAg level will not be higher than 1000 IU/mL. The study will set up three groups, group A directly stopped nucleoside analogues, follow-up to 96 weeks; Group B received PegIFNα-2b monotherapy for 48 weeks, group C received PegIFNα-2b combined with NUC treatment for 48 weeks, group B and group C stopped all antiviral drugs after completing 48 weeks of treatment, and then followed up for 96 weeks, a total of 144 weeks of follow-up. This study aims to further optimize the design on the basis of previous clinical studies to observe whether sequential interferon or combined with NUC therapy can reduce the virological relapse rate of HBeAg-negative chronic hepatitis B patients with low HBsAg level after 96 weeks of discontinuation, and to observe the impact on the functional cure rate.
- Conditions
- Chronic Hepatitis B
- Being tested
- PegIFN alfa-2b, PegIFN alfa-2b and NUC
- 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.
PegIFN alfa-2bDrug
180 μg/ 0.5 ml ,hypodermic injection once a week
PegIFN alfa-2b and NUCDrug
180 μg/ 0.5 ml ,hypodermic injection once a week, NUC drugs should be used according to the instructions of each drug
| Study group | Role | What they receive |
|---|---|---|
| Controlled Group | No intervention | Directly stopped NUC, follow-up to 96 weeks |
| PegIFN alfa-2b 48 weeks | Active comparator | Discontinue the NUC treatment ,PegIFN alfa-2b for 48 weeks and follow up for 96 weeks Receives: Drug: PegIFN alfa-2b |
| PegIFN alfa-2b and NUC 48 weeks | Experimental | Discontinue the NUC treatment ,PegIFN alfa-2b and NUC for 48 weeks, then follow up for 96 weeks Receives: Drug: PegIFN alfa-2b and NUC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who relapse
the cumulative virological relapse rate (HBV DNA>2000 IU/ml on 2 separate occasions 1 months apart) during the research period.
Measured: 96 weeks after stopping NAs
Secondary outcomes (4)
Number of participants who relapse
The total number of relapse (HBV DNA>2000 IU/ml on 2 separate occasions 1 months apart) during the research period.
Measured: 72 weeks after stopping all antivirals
Number of participants who relapse Clinically
Measured: 72 weeks and 96 weeks after stopping all antivirals
Number of participants who achieve HBsAg clearance and HBsAg seroconversion
Measured: 96 weeks after stopping all antivirals
Number of participants who restart treatment
Patients with virological relapse may be retreated according to the following criteria: 1) ALT >10×ULN, 2)ALT >5×ULN and total bilirubin >2 mg/dl, 3)ALT >3×ULN and HBV DNA >100,000 IU/ml, 4) ALT >ULN and HBV DNA >2,000 IU/ml for more than 3 months; 5) PT increases by more than 2s, while ALT >5×ULN.
Measured: 96 weeks after stopping all antivirals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completionApr 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 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiming Zhang, Huashan Hospital
- Investigators
- Principal Investigator Jiming Zhang, M.D., Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900166
- Sponsor's protocol ID
- CEASE2.0
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Papatheodoridi M, Papachristou E, Moschidis Z, Hadziyannis E, Rigopoulou E, Zachou K, Villeret F, Magiorkinis G, Lyberopoulou A, Gatselis N, Vlachogiannakos I, Manolakopoulos S, Dalekos GN, Zoulim F, Paraskevis D, Papatheodoridis GV. Significance of serum HBV RNA in non-cirrhotic HBeAg-negative chronic hepatitis B patients who discontinue effective antiviral therapy. J Viral Hepat. 2022 Nov;29(11):948-957. doi: 10.1111/jvh.13729. Epub 2022 Aug 30.
PubMed 35789515Hirode G, Choi HSJ, Chen CH, Su TH, Seto WK, Van Hees S, Papatheodoridi M, Lens S, Wong G, Brakenhoff SM, Chien RN, Feld J, Sonneveld MJ, Chan HLY, Forns X, Papatheodoridis GV, Vanwolleghem T, Yuen MF, Hsu YC, Kao JH, Cornberg M, Hansen BE, Jeng WJ, Janssen HLA; RETRACT-B Study Group. Off-Therapy Response After Nucleos(t)ide Analogue Withdrawal in Patients With Chronic Hepatitis B: An International, Multicenter, Multiethnic Cohort (RETRACT-B Study). Gastroenterology. 2022 Mar;162(3):757-771.e4. doi: 10.1053/j.gastro.2021.11.002. Epub 2021 Nov 9.
PubMed 34762906Hall SAL, Burns GS, Anagnostou D, Vogrin S, Sundararajan V, Ratnam D, Levy MT, Lubel JS, Nicoll AJ, Strasser SI, Sievert W, Desmond PV, Ngu MC, Angus P, Sinclair M, Meredith C, Matthews G, Revill PA, Jackson K, Littlejohn M, Bowden DS, Locarnini SA, Visvanathan K, Thompson AJ. Stopping nucleot(s)ide analogues in non-cirrhotic HBeAg-negative chronic hepatitis B patients: HBsAg loss at 96 weeks is associated with low baseline HBsAg levels. Aliment Pharmacol Ther. 2022 Jul;56(2):310-320. doi: 10.1111/apt.16968. Epub 2022 May 6.
PubMed 35521992Liaw YF, Kao JH, Piratvisuth T, Chan HL, Chien RN, Liu CJ, Gane E, Locarnini S, Lim SG, Han KH, Amarapurkar D, Cooksley G, Jafri W, Mohamed R, Hou JL, Chuang WL, Lesmana LA, Sollano JD, Suh DJ, Omata M. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2012 update. Hepatol Int. 2012 Jun;6(3):531-61. doi: 10.1007/s12072-012-9365-4. Epub 2012 May 17.
PubMed 26201469European Association For The Study Of The Liver. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. J Hepatol. 2012 Jul;57(1):167-85. doi: 10.1016/j.jhep.2012.02.010. Epub 2012 Mar 20. No abstract available.
PubMed 22436845Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology. 2009 Sep;50(3):661-2. doi: 10.1002/hep.23190. No abstract available.
PubMed 19714720
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Randomized, Controlled, Multicenter Clinical Study of Pegylated Interferon Alfa-2b in Reducing Relapse Rates After Nucleos(t)ide Analogue Withdrawal in HBeAg-Negative Chronic Hepatitis B Patients with Low-Level HBsAg
- ClinicalTrials.gov ID
- NCT06900166
- Acronym / sponsor ID
- CEASE2.0
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 28 Mar 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.
All enrolled patients must meet the European Guidelines for the Prevention and Treatment of Chronic Hepatitis B (EASL, 2017) recommended discontinuation criteria, that is, HBeAg-negative chronic hepatitis B patients without fibrosis or cirrhosis who have undetectable HBV DNA for more than 3 years after receiving NUC treatment can attempt to discontinue the drug. At the same time, the patient's HBsAg level will not be higher than 1000 IU/mL. The study will set up three groups, group A directly stopped nucleoside analogues, follow-up to 96 weeks; Group B received PegIFNα-2b monotherapy for 48 weeks, group C received PegIFNα-2b combined with NUC treatment for 48 weeks, group B and group C stopped all antiviral drugs after completing 48 weeks of treatment, and then followed up for 96 weeks, a total of 144 weeks of follow-up. This study aims to further optimize the design on the basis of previous clinical studies to observe whether sequential interferon or combined with NUC therapy can reduce the virological relapse rate of HBeAg-negative chronic hepatitis B patients with low HBsAg level after 96 weeks of discontinuation, and to observe the impact on the functional cure rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controlled Group | No intervention | –Directly stopped NUC, follow-up to 96 weeks |
| PegIFN alfa-2b 48 weeks | Active comparator | Drug: PegIFN alfa-2bDiscontinue the NUC treatment ,PegIFN alfa-2b for 48 weeks and follow up for 96 weeks |
| PegIFN alfa-2b and NUC 48 weeks | Experimental | Drug: PegIFN alfa-2b and NUCDiscontinue the NUC treatment ,PegIFN alfa-2b and NUC for 48 weeks, then follow up for 96 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 and 65 (inclusive), regardless of gender;
- Fibroscan ≤ 7.4kpa;
- HBeAg-negative CHB patients: HBsAg positive, HBeAg negative, HBsAb negative and HBeAb positive before receiving NUC treatment and during screening in this study;
- HBeAg-negative chronic hepatitis B patients without liver cirrhosis who have been viral-negative for more than 3 years after receiving NUC treatment, and they meet the 2017 EASL guideline discontinuation standard (HBV DNA is lower than the lower limit of detection, that is, <20 IU/ml);
- HBsAg≤1000 IU/ml;
Key exclusion criteria (16 listed)
- HBsAb positive during screening;
- Patients with hepatitis B cirrhosis in the compensatory and decompensated stage: patients with a clear history of cirrhosis (imaging or histological evidence) or Child-Pugh score ≥5 before NUC treatment, or complications of cirrhosis in the decompensated stage such as ascites, hepatic encephalopathy, esophageal variceal hemorrhage, etc.;
- Patients who are allergic to alpha interferon and its drug ingredients, and the researchers judge that alpha interferon is not suitable for patients;
- Received immunomodulators (including interferon, etc.) within 1 year before screening;
- Combined with HAV, HCV, HDV, HEV, HIV infection, alcoholic liver disease, genetic metabolic liver disease, drug liver disease, non-alcoholic fatty liver disease and other chronic liver diseases;
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 |
|---|---|---|
| PegIFN alfa-2b180 μg/ 0.5 ml ,hypodermic injection once a week | Drug | PegIFN alfa-2b 48 weeks |
| PegIFN alfa-2b and NUC180 μg/ 0.5 ml ,hypodermic injection once a week, NUC drugs should be used according to the instructions of each drug | Drug | PegIFN alfa-2b and NUC 48 weeks |
Primary outcome
Number of participants who relapse
Time frame: 96 weeks after stopping NAs
the cumulative virological relapse rate (HBV DNA>2000 IU/ml on 2 separate occasions 1 months apart) during the research period.
4 secondary outcomes
Number of participants who relapse
Time frame: 72 weeks after stopping all antivirals
Number of participants who relapse Clinically
Time frame: 72 weeks and 96 weeks after stopping all antivirals
Number of participants who achieve HBsAg clearance and HBsAg seroconversion
Time frame: 96 weeks after stopping all antivirals
Number of participants who restart treatment
Time frame: 96 weeks after stopping all antivirals
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 28 Mar 2025.
- Background: PubMed 35789515Papatheodoridi M, Papachristou E, Moschidis Z, Hadziyannis E, Rigopoulou E, Zachou K, Villeret F, Magiorkinis G, Lyberopoulou A, Gatselis N, Vlachogiannakos I, Manolakopoulos S, Dalekos GN, Zoulim F, Paraskevis D, Papatheodoridis GV. Significance of serum HBV RNA in non-cirrhotic HBeAg-negative chronic hepatitis B patients who discontinue effective antiviral therapy. J Viral Hepat. 2022 Nov;29(11):948-957. doi: 10.1111/jvh.13729. Epub 2022 Aug 30.
- Background: PubMed 34762906Hirode G, Choi HSJ, Chen CH, Su TH, Seto WK, Van Hees S, Papatheodoridi M, Lens S, Wong G, Brakenhoff SM, Chien RN, Feld J, Sonneveld MJ, Chan HLY, Forns X, Papatheodoridis GV, Vanwolleghem T, Yuen MF, Hsu YC, Kao JH, Cornberg M, Hansen BE, Jeng WJ, Janssen HLA; RETRACT-B Study Group. Off-Therapy Response After Nucleos(t)ide Analogue Withdrawal in Patients With Chronic Hepatitis B: An International, Multicenter, Multiethnic Cohort (RETRACT-B Study). Gastroenterology. 2022 Mar;162(3):757-771.e4. doi: 10.1053/j.gastro.2021.11.002. Epub 2021 Nov 9.
- Background: PubMed 35521992Hall SAL, Burns GS, Anagnostou D, Vogrin S, Sundararajan V, Ratnam D, Levy MT, Lubel JS, Nicoll AJ, Strasser SI, Sievert W, Desmond PV, Ngu MC, Angus P, Sinclair M, Meredith C, Matthews G, Revill PA, Jackson K, Littlejohn M, Bowden DS, Locarnini SA, Visvanathan K, Thompson AJ. Stopping nucleot(s)ide analogues in non-cirrhotic HBeAg-negative chronic hepatitis B patients: HBsAg loss at 96 weeks is associated with low baseline HBsAg levels. Aliment Pharmacol Ther. 2022 Jul;56(2):310-320. doi: 10.1111/apt.16968. Epub 2022 May 6.
- Background: PubMed 26201469Liaw YF, Kao JH, Piratvisuth T, Chan HL, Chien RN, Liu CJ, Gane E, Locarnini S, Lim SG, Han KH, Amarapurkar D, Cooksley G, Jafri W, Mohamed R, Hou JL, Chuang WL, Lesmana LA, Sollano JD, Suh DJ, Omata M. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2012 update. Hepatol Int. 2012 Jun;6(3):531-61. doi: 10.1007/s12072-012-9365-4. Epub 2012 May 17.
- Background: PubMed 22436845European Association For The Study Of The Liver. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. J Hepatol. 2012 Jul;57(1):167-85. doi: 10.1016/j.jhep.2012.02.010. Epub 2012 Mar 20. No abstract available.
- Background: PubMed 19714720Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology. 2009 Sep;50(3):661-2. doi: 10.1002/hep.23190. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Jiming Zhang, M.D. contact
Principal Investigator Jiming Zhang, M.D. principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PegIFN alfa-2b and PegIFN alfa-2b and NUC 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 6 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: opening soon, as of the sponsor's last update on 28 Mar 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jiming Zhang, M.D. (jmzhang2006@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who relapse (time frame: 96 weeks after stopping NAs). 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 NCT06900166, 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 28 Mar 2025.