An observational study in Hepatitis B, Chronic, sponsored by Beijing Municipal Administration of Hospitals. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Beijing Municipal Administration of Hospitals · Observational
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Among 375 studies in Hepatitis B, Chronic with a site in China — 89 open to participants now, 110 under way, 7 of them phase 3. Hepatitis B, Chronic · China.
Among the 375 studies in Hepatitis B, Chronic with a site in China, this one is the 37th largest by planned enrollment of the 99 observational ones that give a count, is one of 27 that started in 2026, is one of 99 observational ones, reaches primary completion later than 72 of the 109 other live ones, and was the 375th registered.
896 studies on the registry are indexed under Hepatitis B, Chronic; 153 are open to participants now.
Browse Hepatitis B, Chronic studies →89 of the 375 studies in Hepatitis B, Chronic with a site in China are open now. Recruiting first, the newest first:
Jiyan Liu · Sites in China
Ages 18–65
Fujian Shengdi Pharmaceutical Co., Ltd. · Sites in China
Ages 18+
Fujian Akeylink Biotechnology Co., Ltd. · Sites in China
Ages 35–65
Ausper Biopharma Co., Ltd. · Sites in China
Ages 18–65 · Healthy volunteers
Zhiliang Gao · Sites in China
Ages 18–65 · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 97 Hepatitis B, Chronic studies recruiting now, 33 (34%) set no upper age limit and 59 (61%) stop at 75 or younger; 11 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
375 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 62 · Phase 2 85 · Phase 3 27 · Phase 4 73
First in 2000; this study’s year is marked. 27 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,000 is above the median of 400 across 207 observational studies indexed under Hepatitis B, Chronic.
Median enrollment 120 across the 273 interventional studies, 500 across the 99 observational. Of the 151 that completed or were terminated, 29 (19%) have results posted.
This tab as a report to print or save as PDF → With an account.
167 of 375 have an industry lead sponsor. The 10 most frequent:
Beijing Municipal Administration of Hospitals is the lead sponsor of 15 studies on the registry; 10 are open to participants now.
Beijing Municipal Administration of Hospitals has 5 studies filed under Hepatitis B, Chronic — fewer than ten, so there is no comparison to draw.
39 of the studies in Hepatitis B, Chronic with a site in China that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07090759Phase 3Fujian Akeylink Biotechnology Co., Ltd.To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment | 2026-12-01 |
| NCT07246889Phase 3Ausper Biopharma Co., Ltd.Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE) | 2026-12-18 |
| NCT07307586Phase 3Zhigang RenA Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B | 2026-12-31 |
| NCT07203118Phase 3Xi'an Xintong Pharmaceutical Research Co.,Ltd.A Phase II/III of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B | 2027-06-30 |
| NCT02863757Humanity and Health Research CentreFollow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease | 2026-12 |
Add all 39 to your calendar (.ics) → With an account.
Among the 375 studies in Hepatitis B, Chronic with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a single-center, cross-sectional, observational study involving approximately 1,000 treatment-naive patients with chronic hepatitis B virus (HBV) infection at Beijing Ditan Hospital, Capital Medical University.
The study aims to investigate the relationship between HBV genetic characteristics, host molecular profiles, and clinical features of chronic HBV infection. Clinical and laboratory information, including liver function tests, HBV DNA levels, hepatitis B surface antigen (HBsAg) levels, and liver fibrosis assessments, will be collected from eligible participants.
Existing clinical data and stored serum samples will be used when authorized and approved by the Ethics Committee. Newly enrolled participants will contribute residual serum samples obtained after routine clinical testing. No additional blood collection or experimental treatment will be required for this study.
HBV whole-genome sequencing data will be analyzed to characterize viral genotypes, mutations, and viral diversity. In approximately 300 selected participants, serum metabolomics, quantitative proteomics, and immune-related factors will also be examined.
By integrating viral, metabolic, protein, immune, and clinical data, this study aims to identify molecular features and potential biomarkers associated with liver inflammation, early liver fibrosis, viral replication, and HBsAg expression. The findings may help improve understanding of differences among patients with chronic HBV infection and provide a basis for future research on risk assessment and disease management.
Study Design This is a single-center, prospective, cross-sectional, observational, and non-interventional study conducted at Beijing Ditan Hospital, Capital Medical University. Approximately 1,000 treatment-naive patients with chronic HBV infection will be included, consisting of approximately 400 eligible existing cases and 600 prospectively enrolled participants.
Study Population Eligible participants will have persistent hepatitis B surface antigen (HBsAg) positivity for more than six months and a diagnosis of chronic HBV infection. Participants must not have received nucleos(t)ide analogues, interferon, or other specified treatments that may significantly affect the study-related indicators before the observation time point.
Patients with other viral hepatitis infections, autoimmune liver disease, alcoholic liver disease, advanced cirrhosis, or hepatocellular carcinoma will be excluded.
Data and Sample Collection Demographic characteristics, clinical history, liver biochemical parameters, liver fibrosis assessment results, and HBV-related virological indicators will be collected from medical records and study databases.
Existing clinical data and stored serum samples will be used only after verification of their original consent and authorization for secondary use, subject to ethics approval. For prospectively enrolled participants, residual serum samples from routine clinical testing will be collected. No additional research-related blood collection will be performed, and routine clinical management will not be altered.
Multi-Omics Analysis HBV whole-genome sequencing data will be used to characterize viral genotypes, subtypes, mutations, and quasispecies diversity. Existing authorized sequencing data will be prioritized, with supplementary sequencing performed when necessary.
Approximately 300 representative participants will be selected according to HBV genotype, HBeAg status, ALT levels, and liver fibrosis status for host multi-omics analyses, including:
Statistical Analysis Statistical analyses will be performed using R software. Group comparisons, correlation analyses, multivariable regression, pathway enrichment, and integrated multi-omics analyses will be conducted. Machine learning methods, including LASSO regression and random forest or XGBoost when appropriate, will be explored to identify relevant molecular features and develop models for clinical phenotypes such as elevated ALT and early liver fibrosis.
Study Objectives The primary objective is to investigate associations between HBV genomic characteristics, host multi-omics profiles, and clinical phenotypes. The study also aims to identify potential biomarkers associated with liver inflammation, early fibrosis, viral replication, and HBsAg expression.
This is an observational study. No investigational drugs, medical devices, or therapeutic interventions will be administered. The study is not designed to establish causal relationships or directly evaluate long-term clinical outcomes.
The study population consists of approximately 1,000 treatment-naive patients with chronic hepatitis B virus (HBV) infection at Beijing Ditan Hospital, Capital Medical University. The study includes approximately 400 eligible existing cases and 600 prospectively enrolled participants. Participants represent different clinical phases of chronic HBV infection. Approximately 300 representative participants will be selected according to HBV genotype, HBeAg status, ALT levels, and liver fibrosis status for multi-omics analyses. Both male and female participants are eligible. No healthy volunteers will be included.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Serum ALT Level by HBV Genomic Characteristic Group
HBV genotypes, subgenotypes, genomic mutations, and quasispecies heterogeneity will be characterized using HBV whole-genome sequencing data. Serum alanine aminotransferase (ALT) levels will be obtained from routine clinical laboratory records and expressed in units per liter (U/L). The association between HBV genomic characteristics and serum ALT levels will be evaluated using appropriate statistical methods.
Time frame: Baseline
APRI Score by HBV Genomic Characteristic Group
The Aspartate Aminotransferase-to-Platelet Ratio Index (APRI) will be calculated using serum AST levels and platelet counts obtained from routine clinical laboratory records. APRI is a dimensionless index. HBV genomic characteristics will be determined using HBV whole-genome sequencing data. APRI values will be compared across prespecified HBV genomic characteristic groups.
Time frame: Baseline
FIB-4 Index by HBV Genomic Characteristic Group
The Fibrosis-4 (FIB-4) index will be calculated using age, serum AST, serum ALT, and platelet count obtained from clinical records. FIB-4 is a dimensionless index. HBV genomic characteristics will be determined using HBV whole-genome sequencing data. FIB-4 values will be compared across prespecified HBV genomic characteristic groups.
Time frame: Baseline
Liver Stiffness Measurement by HBV Genomic Characteristic Group
Liver stiffness measurement (LSM) will be obtained from available clinical liver elastography records and expressed in kilopascals (kPa). HBV genomic characteristics will be determined using HBV whole-genome sequencing data. LSM values will be compared across prespecified HBV genomic characteristic groups.
Time frame: Baseline
Serum HBV DNA Level by HBV Genomic Characteristic Group
Serum HBV DNA levels will be obtained from routine clinical virological testing and expressed in international units per milliliter (IU/mL). HBV genomic characteristics, including genotypes, genomic mutations, and quasispecies features, will be determined using HBV whole-genome sequencing data. Serum HBV DNA levels will be compared across prespecified HBV genomic characteristic groups.
Time frame: Baseline
Quantitative HBsAg Level by HBV Genomic Characteristic Group
Serum quantitative hepatitis B surface antigen (HBsAg) levels will be obtained from routine clinical laboratory records and expressed in international units per milliliter (IU/mL). HBV genomic characteristics will be determined using HBV whole-genome sequencing data. Quantitative HBsAg levels will be compared across prespecified HBV genomic characteristic groups.
Time frame: Baseline
Serum Metabolomic Profiles
Untargeted serum metabolomic profiling will be performed in approximately 300 selected participants using ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS). Metabolites, including lipids, amino acids, bile acids, carbohydrates, and organic acids, will be profiled. The primary data output will consist of normalized relative metabolite abundance values (arbitrary units). Metabolomic profiles will be compared across prespecified clinical and virological subgroups.
Time frame: Baseline
Serum Quantitative Proteomic Profiles
Serum quantitative proteomic profiling will be performed in selected participants using tandem mass tag (TMT)-based quantitative proteomics. Protein expression profiles, including inflammation-related proteins and fibrosis-related proteins, will be characterized. Protein abundance will be expressed as normalized relative quantitative values derived from TMT reporter ion intensities (arbitrary units). Differential protein expression across prespecified clinical and virological subgroups will be evaluated.
Time frame: Baseline
Serum Immune-Related Factor Profiles
Serum immune-related factors will be quantified in selected participants using a multiplex bead-based assay (Luminex technology). The panel includes tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), interleukin-2 (IL-2), interferon-gamma (IFN-γ), interleukin-10 (IL-10), CXCL8, and IP-10 (CXCL10). Factor concentrations will be determined using standard calibration curves and expressed in picograms per milliliter (pg/mL), subject to assay quantification limits. Differences in immune factor concentrations across prespecified clinical and virological subgroups will be evaluated.
Time frame: Baseline
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Aug 2027, 9 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Beijing Municipal Administration of Hospitals