Hepatitis B, Chronic

23

Review clinical trials related to Hepatitis B, Chronic. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions

This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with CHB treated with Nucleos(t)ide Analogue (NAs).

Participants needed: 70
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: AusperBio Therapeutics Inc.Updated: Jun 17, 2026Locations: 9
Eligibility criteria

Adults ≥18 years of age and up to 65 years of age (inclusive) at Screening who a... [+9]

Clinically significant disease other than chronic hepatitis B virus (HBV) infect... [+24]

Status: Recruiting

Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region

This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with Nucleos(t)ide Analogue (NAs).

Participants needed: 84
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: AusperBio Therapeutics Inc.Updated: Jun 1, 2026Locations: 8
Eligibility criteria

Adults ≥18 years of age (or per local age of majority) and ≤65 years of age at S... [+10]

Clinically significant disease other than chronic hepatitis B virus (HBV) infect... [+30]

Status: Not yet recruiting

Study of AHB-171 in Chronic Hepatitis B Participants

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AHB-171 in participants with chronic hepatitis B (CHB). Study advancement to subsequent parts/cohorts will require satisfactory interim reviews of available cumulative safety data by the Safety Review Committees (SRC), using the safety criteria and review procedures described in the protocol.

Participants needed: 144
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: AusperBio Therapeutics Inc.Updated: Jun 1, 2026Locations: 2
Eligibility criteria

Male or female participants, aged 18-65 years old (inclusive) [+9]

Significant medical conditions other than chronic HBV (e.g. recent heart issues,... [+18]

Status: Not yet recruiting

Efficacy and Safety of Pegylated Interferon Alpha-2β in Patients With Hepatitis B-related Hepatocellular Carcinoma After Radical Resection

The goal of this clinical trial is to evaluate the efficacy and safety of peginterferon alfa-2β (Peg-IFN-α-2β) combined with nucleos(t)ide analogues (NAs) in patients aged 18 to 65 years with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) after radical resection. The main questions it aims to answer are: * What are the changes in hepatitis B surface antigen (HBsAg) disappearance rate, HBsAg seroconversion rate, HBsAg decline, and hepatitis B virus deoxyribonucleic acid (HBV DNA) levels during treatment and at the end of treatment? * What are the 1-year, 2-year, 3-year, and 5-year recurrence-free survival (RFS) and overall survival (OS) of the included patients? * What are the correlations between changes in HBsAg, T helper 1/T helper 2 (Th1/Th2) subsets, intestinal flora and RFS, OS in these patients? Researchers will compare Peg-IFN-α-2β combined with NAs to NAs alone to see if the combination treatment can improve HBsAg clearance, seroconversion, long-term survival and reduce recurrence in patients after radical resection of hepatitis B-related hepatocellular carcinoma. Participants will: * Receive either Peg-IFN-α-2β combined with first-line NAs (tenofovir disoproxil fumarate \[TDF\], tenofovir alafenamide fumarate \[TAF\], tenofovir amibufen fumarate \[TMF\]) or first-line NAs alone * Undergo regular assessments including HBsAg, HBV DNA, liver and renal function, blood routine, thyroid function, autoantibodies, and tumor markers * Provide stool samples for intestinal flora analysis at specified time points * Complete long-term survival follow-up for up to 5 years

Participants needed: 156
Trial details
Phase: Early Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: Ningbo No.2 HospitalUpdated: Apr 28, 2026Locations: 4
Eligibility criteria

Age 18 to 65 years, male or female. [+6]

Recurrent or metastatic HCC at enrollment. [+14]

Status: Not yet recruiting

Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis

This study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of traditional Chinese medicine syndrome differentiation as Shi-re-du-yun syndrome and have an aMAP score \>60 points. The objective is to evaluate whether combining Babao Dan Capsule with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.

Participants needed: 1,034
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Nanfang Hospital, Southern Medical UniversityUpdated: Apr 22, 2026
Eligibility criteria

Voluntarily signed informed consent form [+4]

Previously diagnosed with or treated for hepatocellular carcinoma (HCC) or other... [+5]

Status: Recruiting

Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D

Periodontal disease is a chronic inflammatory condition associated with systemic diseases, highlighting the concept of periodontal medicine. This study aims to investigate the relationship between periodontal inflammation, oral lesions, and hepatitis B+D infection, with or without bulevirtide treatment. Oral-periodontal clinical parameters and targeted inflammatory biomarkers in saliva and gingival crevicular fluid will be evaluated in three groups: patients with hepatitis B+D receiving bulevirtide, patients with hepatitis B+D not receiving bulevirtide, and healthy controls.

Participants needed: 25
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Research Center of Periodontal-Systemic InteractionsUpdated: Mar 25, 2026Locations: 2
Eligibility criteria

Adults (≥18 years old) capable of providing informed consent. [+5]

Patients with other systemic diseases that could influence periodontal health (e... [+4]

Status: Not yet recruiting

Effect of Fufang Biejiaruangan Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis: A Multicenter, Randomized, Placebo-controlled Study

This study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of traditional Chinese medicine syndrome differentiation as Qi-zhi-xue\_yu syndrome and have an aMAP score \>60 points. The objective is to evaluate whether combining Bie-jia-ruan-gan with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.

Participants needed: 1,034
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Nanfang Hospital, Southern Medical UniversityUpdated: Mar 18, 2026
Eligibility criteria

Voluntarily signed informed consent form [+4]

[Previously diagnosed with or treated for hepatocellular carcinoma (HCC) or othe... [+5]

Status: Not yet recruiting

Entecavir Resistance-Associated Mutations in Chronic HBV Patients in Turkey (STREAM Study)

Chronic hepatitis B is a long-term viral infection that affects millions of people worldwide. Patients usually require lifelong antiviral treatment to control the virus and prevent liver damage. Some older antiviral medications, such as lamivudine, can lead to the development of viral resistance. This means the virus changes in a way that makes certain treatments less effective. Even though newer drugs like entecavir are stronger and more resistant to these changes, previous exposure to lamivudine may increase the risk of developing additional resistance mutations. By analyzing viral genetic material from blood samples using advanced sequencing technology, this research will help improve understanding of antiviral resistance patterns in patients with chronic hepatitis B in Turkey and may support better treatment decisions in the future.

Participants needed: 700
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: Yaşar Bayındır, MDUpdated: Mar 9, 2026Locations: 1
Eligibility criteria

Age ≥18 years [+4]

Prior entecavir exposure [+3]

Status: Not yet recruiting

Comparison of a Handheld Elastography Device With iLivTouch in Chronic Liver Disease Patients

This single-center cross-sectional study aims to evaluate the agreement between a handheld elastography device and the iLivTouch transient elastography system for the noninvasive assessment of liver fibrosis and steatosis in adults with chronic liver disease. The study compares liver stiffness measurement (LSM) and ultrasound attenuation parameter (UAP) obtained by both devices in the standard supine position, and further explores the feasibility and consistency of measurements performed in the sitting position. All participants will undergo paired examinations using both devices in two body positions (supine and sitting). Agreement between devices and between body positions will be assessed using Bland-Altman analysis, intraclass correlation coefficients, and categorical consistency metrics. The study will also evaluate device performance indicators, including measurement success rate, procedure time, and battery endurance under simulated clinical conditions. This study aims to provide clinical evidence on the accuracy, reliability, and feasibility of a new handheld transient elastography device, and to explore whether sitting-position measurements can serve as an alternative to standard supine assessment in chronic liver disease patients.

Participants needed: 224
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Hong YouUpdated: Nov 21, 2025
Eligibility criteria

Adults aged 18 years or older. [+3]

Chronic liver disease due to other etiologies (e.g., other viral hepatitis, auto... [+10]

Status: Recruiting

Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B

This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.

Participants needed: 45
Trial details
Phase: Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: Precision BioSciences, Inc.Updated: Sep 26, 2025Locations: 4
Eligibility criteria

Male or women of non-child bearing potential [+5]

No history of cirrhosis of the liver [+5]

Status: Recruiting

Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection [VISION]

This is a Phase II Investigator-Initiated Study to understand the vaccinal effect of HBsAg monoclonal Ab VIR-3434 in chronic hepatitis B infection. The purpose of this study is to test VIR-3434, an experimental drug that specifically targets the HBsAg of hepatitis B virus, to clear it from the body. This is an open label study and there is no placebo used in this study. All participants will receive the VIR-3434 for 48 weeks and then follow up in the study for 48 weeks. A total duration of approximately 104 weeks including screening period for the entire study.

Participants needed: 15
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: University Health Network, TorontoUpdated: May 29, 2025Locations: 1
Eligibility criteria

Age ≥ 18 to ≤65 years [+8]

History of cirrhosis as evidenced by prior Liver Elastography (Fibroscan) > 12 k... [+22]

Status: Recruiting

Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients

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.

Participants needed: 5,000
Trial details
Phase: Phase 4Age: 18-60Biological sex: AllType: InterventionalSponsor: Third Affiliated Hospital, Sun Yat-Sen UniversityUpdated: May 1, 2025Locations: 1
Eligibility criteria

Age 18-60, no gender limitation [+6]

Allergic to pegylated interferon α-2b [+13]

Status: Not yet recruiting

Sequential PEG-IFN for HBV After Ending RNA-targeted Regimens

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. What are the HBsAg clearance and relapse rates after 24 weeks of PEG-IFNα therapy? 3. 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).

Participants needed: 30
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Huashan HospitalUpdated: Apr 11, 2025Locations: 1
Eligibility criteria

Age ≥18 years. [+9]

Decompensated cirrhosis or hepatic malignancy (evidenced by imaging or histology... [+17]

Status: Recruiting

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

This is a multicentre observational study with prospective and retrospective data collection and retrospective data collection and biological collection from patients with HBV/HDV co-infection.

Participants needed: 800
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: ANRS, Emerging Infectious DiseasesUpdated: Feb 5, 2025Locations: 38Duration: 7 Years
Eligibility criteria

Age > 18 years, [+3]

Patient participating in another biomedical research with an exclusion period on... [+2]

Status: Recruiting

Combination of DPMAS and Low Volume PE for Patients With HBV Related ACLF

This study is to investigate investigate the safety and efficacy of Double plasma molecular adsorption system with sequential low-dose plasma exchange in treating hepatitis B virus-related acute-on-chronic liver failure.

Participants needed: 200
Trial details
Age: 18-65Biological sex: AllType: ObservationalSponsor: Third Affiliated Hospital, Sun Yat-Sen UniversityUpdated: Nov 29, 2024Locations: 1
Eligibility criteria

Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b... [+3]

Other active liver diseases; [+8]

Status: Recruiting

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

The goal of this observational study is to learn about the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay which has improved sensitivity compared to current ARCHITECT HBsAg Assay. The main question it aims to answer is: What's the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay? HBsAg NEXT assay technology (lower limit of detection for HBsAg is 0.005 IU/ml) and current ARCHITECT HBsAg assay (lower limit of detection for HBsAg is 0.05 IU/ml) are applied for HBsAg detection in patients achieving functional cure, and to compare the difference in HBsAg reversion rate 48 weeks off treatment under the two types of criteria.

Participants needed: 300
Trial details
Age: 18-65Biological sex: AllType: ObservationalSponsor: Huashan HospitalUpdated: Aug 13, 2024Locations: 1
Eligibility criteria

HBsAg-negative by Abbott's HBsAg Test and HBeAg-negative; [+2]

Patients with hepatitis B cirrhosis in the compensated and decompensated stages:... [+6]

Status: Recruiting

A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B

This is a prospective, multicentre observational study of Chronic Hepatitis B (CHB)in different clinical stages. We intend to compare the immune status of various types of CHB patients, and we propose to establish a staging and grading criteria for the immune exhaustion status of patients with CHB.

Participants needed: 250
Trial details
Age: 18-50Biological sex: AllType: ObservationalSponsor: Tongji HospitalUpdated: Jul 29, 2024Locations: 5
Eligibility criteria

Patients with CHB who were older than 18 years old and younger than 50 years old... [+2]

Pregnancy status; [+8]

Status: Not yet recruiting

A Clinical Study to Evaluate the Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B

This study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of TQA3038 injection in patients with chronic hepatitis B. It is expected to include 72 subjects. Phase IIa adopted an open-label, randomized, parallel-controlled design, with a total of 90 subjects included, mainly evaluating the changes in serum HBsAg compared to baseline at the end of the 48th week.

Participants needed: 162
Trial details
Phase: Phase 1, Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Updated: Jun 11, 2024Locations: 22
Eligibility criteria

Subjects voluntarily participate in this study and sign informed consent; [+7]

Pregnant and lactating women; [+19]

Status: Recruiting

HBsAg Declined Patients Follow-up Study

The goal of this observational study is to prospectively follow chronic hepatitis B patients who had HBsAg decline in the past 12 months prior to screening. The main question it aims to answer are: \- Describe treatment pattern and its impact on HBsAg loss in hepatitis B patients who had HBsAg decline in past 12 months due to any reason (with or without new molecular entities therapy). Participants will be followed up for 36 months after enrollment and may be extended upon expiration according to study objectives.

Participants needed: 100
Trial details
Age: 18-65Biological sex: AllType: ObservationalSponsor: Nanfang Hospital, Southern Medical UniversityUpdated: Feb 20, 2024Locations: 1
Eligibility criteria

Participants must have HBsAg decline ≥0.5 log10 IU/mL in past 12 months prior to... [+1]

Any condition which, in the opinion of the investigator, contraindicates their p... [+1]

Status: Recruiting

Real-world Study Optimizing Nucleotide-analogues

The goal of this multicenter, observational, prospective study is to observe and compare different anti-viral treatment strategies in a real-world cohort of patients with CHB managed in routine clinical settings in China. The main questions it aims to answer are: 1. To evaluate the benefits of initiating first-line nucleos(t)ide analogue in patients with chronic HBV infection who are recommended in the updated Chinese Guideline 2022, but not recommended in the Chinese Guideline 2019. 2. To evaluate the Chinese Guideline recommends initiation of treatment, but at least one foreign authoritative guideline (eg. AASLD, EASL) does not recommend the benefit of initiating first-line nucleos(t)ide analogue in patients with chronic HBV infection who initiate treatment. 3. To compare the treatment effect of different alternatives with patients who have partial response after treatment with first-line nucleos(t)ide analogues.

Participants needed: 20,000
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: Huashan HospitalUpdated: Jul 10, 2023Locations: 44
Eligibility criteria

CHB defined as positive hepatitis B surface antigen at least 6 months, or HBV-re... [+6]

Have poor compliance; [+2]

Status: Recruiting

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Previous studies have shown that there are alterations in the number and affinity of interferon receptors during interferon therapy and that such alterations recover to varying degrees some time after the end of treatment. It can be conjectured that the rest period of pulsed therapy facilitates the recovery of type I interferon receptors and thus the next round of IFN therapy compared to a continuous regimen of interferon.

Participants needed: 1,084
Trial details
Phase: Early Phase 1Age: 18-60Biological sex: AllType: InterventionalSponsor: Anhui Medical UniversityUpdated: Jun 28, 2023Locations: 1
Eligibility criteria

Age 18 to 60 years, both sexes (both 18 and 60 years) [+4]

Combined active hepatitis A, C, D, E and/or HIV infection; [+12]

Status: Recruiting

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

The goal of this study is to evaluate whether the standardized liver cancer risk stratification management can effectively improve the early diagnosis rate of liver cancer in the targeted risk population in China.

Participants needed: 20,000
Trial details
Age: 18-75Biological sex: AllType: ObservationalSponsor: Ruijin HospitalUpdated: May 23, 2023Locations: 1
Eligibility criteria

Voluntary participation in the clinical study; fully informed about the study an... [+15]

Age <18 years or >75 years [+5]

Status: Recruiting

"Real-life" Cohort Study on Patients With Chronic HBV Infection in Jiangsu

Hepatitis B virus (HBV) infection remains one of the most serious health problems worldwide. Patients with chronic HBV infection are at an increased risk for developing hepatic cirrhosis, hepatocellular carcinoma and even death. Although some predictive factors of the outcome of chronic HBV infection were identified, more precisely determine the factors which are associated with the outcome in non-selected patients with chronic HBV infection are still needed. The investigators purpose is to constitute a observational cohort of non-selected Chinese patients to create a database of epidemiological, clinical, biological, virological, immunologic and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.

Participants needed: 20,000
Trial details
Biological sex: AllType: ObservationalSponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUpdated: Mar 31, 2017Locations: 6
Eligibility criteria

Patients with chronic HBV infection (defined as HBsAg positive for at least 6 mo...

Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) an... [+2]