Hepatitis B, ChronicPhase 4NCT05182463
Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients
A Phase 4 study testing Peginterferon Alfa-2B and Nucleoside Analogs in people with Hepatitis B, Chronic, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
There are about 400 million chronic hepatitis B virus (HBV) infection patients worldwide, posing a serious threat to global public health security. In China, HBV infection occured mainly in the perinatal period or infants, and about 10% of patients in the immune tolerance stage spontaneously transit to the immune… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Peginterferon Alfa-2B and Nucleoside Analogs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2022to 30 Nov 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60, no gender limitation
- HBsAg is positive for more than 6 months
- Hepatitis B e antigen(HBeAg) is negative and anti-HBe is positive
- Serum HBV DNA is less than 2000 IU/mL
- Alanine aminotransferase(ALT) and/or Aspartate aminotransferase(AST) is normal
- No antiviral durg (including nucleos(t)ide analogue and interferon) was used before enrollment
- Good compliance and voluntarily signed informed consent
Who cannot join
- Allergic to pegylated interferon α-2b
- Any indication of liver cirrhosis
- Coinfection with hepatitis A virus(HAV), hepatitis C virus(HCV), hepatitis D virus(HDV), hepatitis E virus(HEV) or human immunodeficiency virus(HIV)
- Combined with other liver diseases (including drug-related, alcoholic, autoimmune, genetic metabolic liver diseases, etc.)
- There are serious lesions in the important organs, such as heart, lung, kidney, brain and fundus
- Patients with autoimmune diseases, unstable diabetes or thyroid diseases(hyperthyroidism or hypothyroidism)
Show all 14Show fewer
- Confirmed or suspected liver cancer or other malignant tumors
- Patients after or preparing for organ transplantation
- Peripheral blood white blood cell count < 3.5×109/L and/or platelet count < 80×109/L
- Under immunosuppressant treatment
- Pregnant or planned pregnancy in a short term or lactation patients
- Alcohol abuse (average alcohol intake is more than 40 g/d in males or 20g/d in women) or drug addicts
- Present or past history of mental or psychological diseases
- Other conditions that the investigators deem inappropriate for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Zhi-Liang Gao, Professor, 86-20-85252373, zhilianggao@21cn.com
Xiang Zhu, Doctor, 86-20-85252372, 0628zhuxiang@163.com
About this study
Official title: Real World Study of Peginterferon Alpha-2b Treatment for Inactive Chronic Hepatitis B Patients: E-Cure Study
There are about 400 million chronic hepatitis B virus (HBV) infection patients worldwide, posing a serious threat to global public health security. In China, HBV infection occured mainly in the perinatal period or infants, and about 10% of patients in the immune tolerance stage spontaneously transit to the immune clearance stage every year and become HBeAg-negative chronic HBV infection, resulting in a significant increase in the number of inactive chronic hepatitis B (CHB) patients.
In recent years, different guidelines have not reached consensus on the need to initiate antiviral therapy for inactive CHB patients: In the guidelines of Asian Pacific Association for The Study of Liver(APASL)-2015 and American Association for the Study of Liver Diseases(AASLD)-2018, antiviral therapy is generally not recommended for this group of patients, and regular outpatient follow-up is recommended. Guideline of European Association for the Study of the Liver(EASL)-2017 suggests that people with a family history of cirrhosis and liver cancer at this stage could be treated with antiviral therapy even if they did not meet the indications of antiviral therapy. According to Guidelines for the Prevention and Treatment of Chronic Hepatitis B (version 2019) of China, antiviral therapy is still recommended for some patients with inactive HBsAg carrier status who are HBV DNA positive and meet the treatment indications. Studies have shown that some patients in immune tolerance stage may enter the immune clearance stage and have hepatitis flare. Patients of inactive CHB have the potential to develop HBeAg-negative CHB, and studies of long-term follow-up in this population have indicated the risk of hepatocellular carcinoma. With the popularization of the concept of functional cure for chronic hepatitis B, more and more people with inactive CHB have a strong desire for treatment. In recent years, several studies have demonstrated that Pegylated-interferon therapy can achieve high functional cure rate in patients with inactive CHB.
The purpose of this study is to establish a national multi-center, prospective real world study to compare the efficacy of different antiviral treatment regimens for patients with inactive CHB and seek for the factors of functional cure.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Peginterferon Alfa-2B, Nucleoside Analogs
- Keywords
- inactive chronic hepatitis B, functional cure
- 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.
Peginterferon Alfa-2BDrug
Different usage of peginterferon Alfa-2B and/or Nucleos(t)ide analogs in arm/group descriptions are depended on the wishes of the patient and the advice of the attending doctor.
Nucleoside AnalogsDrug
Nucleos(t)ide analogs refer to one of the first-line drugs, including ETV, TDF and TAF.
| Study group | Role | What they receive |
|---|---|---|
| Sequential Combination Group | Experimental | Oral nucleos(t)ide analogues (NAs) (Entecavir(ETV), Tenofovir disoproxil fumarate tablets(TDF) or Tenofovir Alafenamide Fumarate(TAF)) is used for 12-24 weeks, followed by combination therapy with peginterferon α-2b. The Maximum course is 96 weeks. Follow-up period is 144 weeks. Receives: Drug: Peginterferon Alfa-2B; Drug: Nucleoside Analogs |
| Initial Combination Group | Experimental | NAs combined with peginterferon are used for 12-24 weeks, followed by peginterferon α-2b. The Maximum course is 96 weeks. Follow-up period is 144 weeks. Receives: Drug: Peginterferon Alfa-2B; Drug: Nucleoside Analogs |
| Whole-course Combination Group | Experimental | NAs combined with peginterferon are used for a maximum course of 96 weeks. Follow-up period is 144 weeks. Receives: Drug: Peginterferon Alfa-2B; Drug: Nucleoside Analogs |
| Peginterferon Monotherapy Group | Experimental | Peginterferon is used for a maximum course of 96 weeks. Follow-up period is 144 weeks. Receives: Drug: Peginterferon Alfa-2B |
| NAs Monotherapy Group | Experimental | NAs is used for a maximum course of 96 weeks. Follow-up period is 144 weeks. Receives: Drug: Nucleoside Analogs |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg clearance rate
HBsAg is detected by Roche or Abbott productions, of which the lower limit is 0.05 IU/ml
Measured: From date of the beginning of treatment until the date of the end of treatment, assessed up to 96 weeks
Secondary outcomes (4)
HBsAg serological conversion rate
HBsAg is detected by Roche or Abbott productions, of which the lower limit is 0.05 IU/ml
Measured: From date of the beginning of treatment until the date of the end of treatment, assessed up to 96 weeks
The magnitude of HBsAg decline from baseline
HBsAg is detected by quantitative assays from Roche or Abbott
Measured: through treatment completion, an anticipated period of 96 weeks
The magnitude of HBV-DNA decline from baseline and the undetectable rate
HBV-DNA is detected by assays from Roche or Abbott, of which the lower limit is 15 or 10 IU/ml.
Measured: through treatment completion, an anticipated period of 96 weeks
HBsAg clearance rate, HBsAg serological conversion rate and maintenance response rate of HBsAg clearance
HBsAg is detected by Roche or Abbott productions, of which the lower limit is 0.05 IU/ml
Measured: through follow-up completion, an anticipated period of 144 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start8 Jan 2022
- Primary completion13 Dec 2026 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiliang Gao, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Zhiliang Gao, Doctor, Study chair, Third Affiliated Hospital, Sun Yat-Sen UniversityGuizhou Zou, Principal investigator, The Second Hospital of Anhui Medical UniversityJiabin Li, Principal investigator, The First Affiliated Hospital of Anhui Medical UniversityZhende Lin, Principal investigator, Anxi County HospitalGuoxin Hu, Principal investigator, SHENZHEN HOSPITAL of PEKING UNIVERSITYYouping Lin, Principal investigator, Dongguan Binhai Bay Central HospitalSichun Yin, Principal investigator, Dongguan Ninth People's HospitalSongmei He, Principal investigator, Dongguan People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182463
- Sponsor's protocol ID
- [2021]02-373-01
- Status last verified
- Apr 2025
- First submitted
- 18 Dec 2021
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data would be available to other researchers with the approval of the ethics committee
Publications
Li MH, Xie Y, Zhang L, Lu Y, Shen G, Wu SL, Chang M, Mu CQ, Hu LP, Hua WH, Song SJ, Zhang SF, Cheng J, Xu DZ. Hepatitis B surface antigen clearance in inactive hepatitis B surface antigen carriers treated with peginterferon alfa-2a. World J Hepatol. 2016 May 28;8(15):637-43. doi: 10.4254/wjh.v8.i15.637.
PubMed 27239256Cao Z, Liu Y, Ma L, Lu J, Jin Y, Ren S, He Z, Shen C, Chen X. A potent hepatitis B surface antigen response in subjects with inactive hepatitis B surface antigen carrier treated with pegylated-interferon alpha. Hepatology. 2017 Oct;66(4):1058-1066. doi: 10.1002/hep.29213. Epub 2017 Aug 26.
PubMed 28407271Wu F, Lu R, Liu Y, Wang Y, Tian Y, Li Y, Li M, Wang W, Zhang X, Jia X, Dang S. Efficacy and safety of peginterferon alpha monotherapy in Chinese inactive chronic hepatitis B virus carriers. Liver Int. 2021 Sep;41(9):2032-2045. doi: 10.1111/liv.14897. Epub 2021 May 26.
PubMed 33896094Liu J, Lee MH, Batrla-Utermann R, Jen CL, Iloeje UH, Lu SN, Wang LY, You SL, Hsiao CK, Yang HI, Chen CJ. A predictive scoring system for the seroclearance of HBsAg in HBeAg-seronegative chronic hepatitis B patients with genotype B or C infection. J Hepatol. 2013 May;58(5):853-60. doi: 10.1016/j.jhep.2012.12.006. Epub 2012 Dec 13.
PubMed 23246508Huang Y, Qi M, Liao C, Xun J, Zou J, Huang H, Long LY, Chen J, Fan X, Chen R. Analysis of the Efficacy and Safety of PEGylated Interferon-alpha2b Treatment in Inactive Hepatitis B Surface Antigen Carriers. Infect Dis Ther. 2021 Dec;10(4):2323-2331. doi: 10.1007/s40121-021-00511-w. Epub 2021 Aug 4.
PubMed 34350562Zeng QL, Yu ZJ, Shang J, Xu GH, Sun CY, Liu N, Li CX, Lv J, Liu YM, Liang HX, Li ZQ, Pan YJ, Hu QY, Li W, Zhang DW, Wang FS. Short-term Peginterferon-Induced High Functional Cure Rate in Inactive Chronic Hepatitis B Virus Carriers With Low Surface Antigen Levels. Open Forum Infect Dis. 2020 Jun 3;7(6):ofaa208. doi: 10.1093/ofid/ofaa208. eCollection 2020 Jun.
PubMed 32626791Chang LJ, Hao CQ, Rao GR, Xu LL, Li J, Cheng Y, Zheng LJ, Wu CW, Chen HX, Chen ZR, Lian JQ, Wu SH, Luo LM, Zhang WL, Zhang Y. Recurrence risk factors for chronic hepatitis B virus-infected patients who achieve functional cure with pegylated interferon-alpha-2b-based therapy: a multicenter pilot study. Virol J. 2025 May 19;22(1):146. doi: 10.1186/s12985-025-02761-3.
PubMed 40390028
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study of Peginterferon Alpha-2b Treatment for Inactive Chronic Hepatitis B Patients: E-Cure Study
- ClinicalTrials.gov ID
- NCT05182463
- Acronym / sponsor ID
- [2021]02-373-01
- Conditions
- Hepatitis B, Chronic
- Keywords
- inactive chronic hepatitis B, functional cure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 8 Jan 2022 (actual)
- Primary completion
- 13 Dec 2026 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 10 Jan 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.
There are about 400 million chronic hepatitis B virus (HBV) infection patients worldwide, posing a serious threat to global public health security. In China, HBV infection occured mainly in the perinatal period or infants, and about 10% of patients in the immune tolerance stage spontaneously transit to the immune clearance stage every year and become HBeAg-negative chronic HBV infection, resulting in a significant increase in the number of inactive chronic hepatitis B (CHB) patients.
In recent years, different guidelines have not reached consensus on the need to initiate antiviral therapy for inactive CHB patients: In the guidelines of Asian Pacific Association for The Study of Liver(APASL)-2015 and American Association for the Study of Liver Diseases(AASLD)-2018, antiviral therapy is generally not recommended for this group of patients, and regular outpatient follow-up is recommended. Guideline of European Association for the Study of the Liver(EASL)-2017 suggests that people with a family history of cirrhosis and liver cancer at this stage could be treated with antiviral therapy even if they did not meet the indications of antiviral therapy. According to Guidelines for the Prevention and Treatment of Chronic Hepatitis B (version 2019) of China, antiviral therapy is still recommended for some patients with inactive HBsAg carrier status who are HBV DNA positive and meet the treatment indications. Studies have shown that some patients in immune tolerance stage may enter the immune clearance stage and have hepatitis flare. Patients of inactive CHB have the potential to develop HBeAg-negative CHB, and studies of long-term follow-up in this population have indicated the risk of hepatocellular carcinoma. With the popularization of the concept of functional cure for chronic hepatitis B, more and more people with inactive CHB have a strong desire for treatment. In recent years, several studies have demonstrated that Pegylated-interferon therapy can achieve high functional cure rate in patients with inactive CHB.
The purpose of this study is to establish a national multi-center, prospective real world study to compare the efficacy of different antiviral treatment regimens for patients with inactive CHB and seek for the factors of functional cure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sequential Combination Group | Experimental | Drug: Peginterferon Alfa-2B, Drug: Nucleoside AnalogsOral nucleos(t)ide analogues (NAs) (Entecavir(ETV), Tenofovir disoproxil fumarate tablets(TDF) or Tenofovir Alafenamide Fumarate(TAF)) is used for 12-24 weeks, followed by combination therapy with peginterferon α-2b. The Maximum course is 96 weeks. Follow-up period is 144 weeks. |
| Initial Combination Group | Experimental | Drug: Peginterferon Alfa-2B, Drug: Nucleoside AnalogsNAs combined with peginterferon are used for 12-24 weeks, followed by peginterferon α-2b. The Maximum course is 96 weeks. Follow-up period is 144 weeks. |
| Whole-course Combination Group | Experimental | Drug: Peginterferon Alfa-2B, Drug: Nucleoside AnalogsNAs combined with peginterferon are used for a maximum course of 96 weeks. Follow-up period is 144 weeks. |
| Peginterferon Monotherapy Group | Experimental | Drug: Peginterferon Alfa-2BPeginterferon is used for a maximum course of 96 weeks. Follow-up period is 144 weeks. |
| NAs Monotherapy Group | Experimental | Drug: Nucleoside AnalogsNAs is used for a maximum course of 96 weeks. Follow-up period is 144 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-60, no gender limitation
- HBsAg is positive for more than 6 months
- Hepatitis B e antigen(HBeAg) is negative and anti-HBe is positive
- Serum HBV DNA is less than 2000 IU/mL
- Alanine aminotransferase(ALT) and/or Aspartate aminotransferase(AST) is normal
Key exclusion criteria (14 listed)
- Allergic to pegylated interferon α-2b
- Any indication of liver cirrhosis
- Coinfection with hepatitis A virus(HAV), hepatitis C virus(HCV), hepatitis D virus(HDV), hepatitis E virus(HEV) or human immunodeficiency virus(HIV)
- Combined with other liver diseases (including drug-related, alcoholic, autoimmune, genetic metabolic liver diseases, etc.)
- There are serious lesions in the important organs, such as heart, lung, kidney, brain and fundus
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 |
|---|---|---|
| Peginterferon Alfa-2BDifferent usage of peginterferon Alfa-2B and/or Nucleos(t)ide analogs in arm/group descriptions are depended on the wishes of the patient and the advice of the attending doctor. | Drug | Initial Combination Group, Peginterferon Monotherapy Group, Sequential Combination Group, Whole-course Combination Group |
| Nucleoside AnalogsNucleos(t)ide analogs refer to one of the first-line drugs, including ETV, TDF and TAF. | Drug | Initial Combination Group, NAs Monotherapy Group, Sequential Combination Group, Whole-course Combination Group |
Primary outcome
HBsAg clearance rate
Time frame: From date of the beginning of treatment until the date of the end of treatment, assessed up to 96 weeks
HBsAg is detected by Roche or Abbott productions, of which the lower limit is 0.05 IU/ml
4 secondary outcomes
HBsAg serological conversion rate
Time frame: From date of the beginning of treatment until the date of the end of treatment, assessed up to 96 weeks
The magnitude of HBsAg decline from baseline
Time frame: through treatment completion, an anticipated period of 96 weeks
The magnitude of HBV-DNA decline from baseline and the undetectable rate
Time frame: through treatment completion, an anticipated period of 96 weeks
HBsAg clearance rate, HBsAg serological conversion rate and maintenance response rate of HBsAg clearance
Time frame: through follow-up completion, an anticipated period of 144 weeks
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 1 May 2025.
- Background: PubMed 27239256Li MH, Xie Y, Zhang L, Lu Y, Shen G, Wu SL, Chang M, Mu CQ, Hu LP, Hua WH, Song SJ, Zhang SF, Cheng J, Xu DZ. Hepatitis B surface antigen clearance in inactive hepatitis B surface antigen carriers treated with peginterferon alfa-2a. World J Hepatol. 2016 May 28;8(15):637-43. doi: 10.4254/wjh.v8.i15.637.
- Background: PubMed 28407271Cao Z, Liu Y, Ma L, Lu J, Jin Y, Ren S, He Z, Shen C, Chen X. A potent hepatitis B surface antigen response in subjects with inactive hepatitis B surface antigen carrier treated with pegylated-interferon alpha. Hepatology. 2017 Oct;66(4):1058-1066. doi: 10.1002/hep.29213. Epub 2017 Aug 26.
- Background: PubMed 33896094Wu F, Lu R, Liu Y, Wang Y, Tian Y, Li Y, Li M, Wang W, Zhang X, Jia X, Dang S. Efficacy and safety of peginterferon alpha monotherapy in Chinese inactive chronic hepatitis B virus carriers. Liver Int. 2021 Sep;41(9):2032-2045. doi: 10.1111/liv.14897. Epub 2021 May 26.
- Background: PubMed 23246508Liu J, Lee MH, Batrla-Utermann R, Jen CL, Iloeje UH, Lu SN, Wang LY, You SL, Hsiao CK, Yang HI, Chen CJ. A predictive scoring system for the seroclearance of HBsAg in HBeAg-seronegative chronic hepatitis B patients with genotype B or C infection. J Hepatol. 2013 May;58(5):853-60. doi: 10.1016/j.jhep.2012.12.006. Epub 2012 Dec 13.
- Background: PubMed 34350562Huang Y, Qi M, Liao C, Xun J, Zou J, Huang H, Long LY, Chen J, Fan X, Chen R. Analysis of the Efficacy and Safety of PEGylated Interferon-alpha2b Treatment in Inactive Hepatitis B Surface Antigen Carriers. Infect Dis Ther. 2021 Dec;10(4):2323-2331. doi: 10.1007/s40121-021-00511-w. Epub 2021 Aug 4.
- Background: PubMed 32626791Zeng QL, Yu ZJ, Shang J, Xu GH, Sun CY, Liu N, Li CX, Lv J, Liu YM, Liang HX, Li ZQ, Pan YJ, Hu QY, Li W, Zhang DW, Wang FS. Short-term Peginterferon-Induced High Functional Cure Rate in Inactive Chronic Hepatitis B Virus Carriers With Low Surface Antigen Levels. Open Forum Infect Dis. 2020 Jun 3;7(6):ofaa208. doi: 10.1093/ofid/ofaa208. eCollection 2020 Jun.
- Derived from this study: PubMed 40390028Chang LJ, Hao CQ, Rao GR, Xu LL, Li J, Cheng Y, Zheng LJ, Wu CW, Chen HX, Chen ZR, Lian JQ, Wu SH, Luo LM, Zhang WL, Zhang Y. Recurrence risk factors for chronic hepatitis B virus-infected patients who achieve functional cure with pegylated interferon-alpha-2b-based therapy: a multicenter pilot study. Virol J. 2025 May 19;22(1):146. doi: 10.1186/s12985-025-02761-3.
- Individual participant dataSharing planned: No. Individual participant data would be available to other researchers with the approval of the ethics committee
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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.
Zhiliang Gao, Doctor study chair
Third Affiliated Hospital, Sun Yat-Sen University
Guizhou Zou principal investigator
The Second Hospital of Anhui Medical University
Jiabin Li principal investigator
The First Affiliated Hospital of Anhui Medical University
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 Peginterferon Alfa-2B and Nucleoside Analogs in people with Hepatitis B, Chronic, run by Third Affiliated Hospital, Sun Yat-Sen University 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 7 inclusion and 14 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 1 May 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 Zhishuo Mo, Master (+86 13632434363, vbstone@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBsAg clearance rate (time frame: From date of the beginning of treatment until the date of the end of treatment, assessed up to 96 weeks). 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 NCT05182463, which also lists 7 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 1 May 2025.