Chronic Hepatitis BNCT06779058
MR Elastography for Assessing Liver Fibrosis in Chronic Hepatitis B
An observational study of Chronic Hepatitis B and Liver Fibrosis, run by Shengjing Hospital at 1 site in China.
Trial summary
How to construct a non-invasive, accurate, and convenient method to evaluate the severity of liver fibrosis (LF) is an important general problem in the management of patients with chronic hepatitis B (CHB). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Hepatitis B, Liver Fibrosis
- What is being tested?
- MRE and Liver biopsy
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Organize paticipating units to collect standard-of-care data including radiological and clinical data. Patients diagnosed with CHB who received liver biopsy and MRE should be enrolled.
Who may be able to join
- Age ≥ 18 years old
- Confirmed CHB (laboratory, imaging and clinical tests)
- MRE within 6 months before and after liver biopsy
- Treatment-naïve
- Child-Pugh Grade A (<7 points)
- Written informed consent in prospective follow-up cohort
Who cannot join
- Patients with liver malignant tumor
- Chronic hepatitis due to other causes (such as alcoholic hepatitis)
- CHB combined with hepatitis C, hepatitis D, or HIV
- Patients with biliary tract diseases
- Contraindications of MRE examination, MRE failure
- Poor pathological effect
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
Shengjing Hospital
Shenyang, Liaoning, 210000
Yiyang Wang, +86 15291014907, 15291014907@163.com
Yu Shi, +86 18940259980, 18940259980@163.com
About this study
Official title: Retrospective and Prospective Multi-center Clinical Study of Magnetic Resonance Elastography in Evaluating Hepatic Fibrosis in Chronic Viral Hepatitis B
How to construct a non-invasive, accurate, and convenient method to evaluate the severity of liver fibrosis (LF) is an important general problem in the management of patients with chronic hepatitis B (CHB). We plan to investigate the ability of magnetic resonance elastography (MRE) to grade fibrosis in chronic hepatitis B and apply to clinical longitudinal follow-up.
Read the detailed description
Hepatitis B virus (HBV) infection is the most prevalent chronic viral infection worldwide, affecting 254 million people and resulting in 1.2 million new infections annually . Chronic hepatitis B (CHB) is strongly associated with liver fibrosis, cirrhosis, hepatocellular carcinoma, and death. Patients with chronic hepatitis C (CHC) can achieve an overall cure rate of more than 95% after 12 weeks of treatment with direct-acting antiviral agent (DAA). However, patients with chronic hepatitis B still need long-term management due to the complexity and persistence of their disease. Therefore, rapid, stable and accurate assessment of the disease status of hepatitis B patients and clear classification of liver fibrosis are of great significance for clinical management of chronic hepatitis B patients.
Meanwhile, Antiviral therapy can significantly slow liver disease progression and improve long-term survival in CHB patients. Treatment is only recommended for CHB adults when histological evidences ≥ F2; evidence of F4 based on clinical criteria; HBV DNA > 2000 IU/mL with ALT > ULN (Men: 30 U/L, Women: 19 U/L); or persistent ALT abnormality. For treated patients, imaging and clinical indicators are monitored every six months during the first year, then annually. For untreated patients, monitoring is conducted on an annual basis . However, these current tests often fail to reflect pathological changes in real-time, as they tend to lag behind actual disease progression. Therefore, finding an effective method for regular follow-up is also essential for both treated and untreated patients.
The current diagnostic gold standard, liver biopsy, has limitations due to its invasive nature, sampling error, complications, and high cost, making it impractical for evaluating liver fibrosis and longitudinal monitoring in CHB patients. There is an urgent need for noninvasive evaluation of liver fibrosis and antiviral treatment efficacy. Magnetic resonance elastography (MRE) has shown promise in assessing liver fibrosis and necroinflammation in CHB patients. At present, there are few studies on CHB, all of which are single-center studies. The reported cut-off point is not uniform, which is generally lower than the international standard, and whether 2D/3D MRE affects the threshold are inconsistent. Therefore, a multi-center clinical study on the evaluation of CHB fibrosis based on MRE and its application in clinical longitudinal follow-up need to be carried out.
- Conditions
- Chronic Hepatitis B, Liver Fibrosis
- Being tested
- MRE, Liver biopsy
- Keywords
- Magnetic resonance elastography, Liver stiffness, Antiviral therapy
- Medical subject headings
- Hepatitis B, Chronic, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MREDevice
All imaging studies were performed by using a 1.5T/3.0-T MRI system
Liver biopsyDevice
Liver biopsy are performed by well-trained pathologists in accordance with standard operating procedures.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort of patients confirmed diagnosed with chronic hepatitis B | Patients aged ≥ 18 who have been diagnosed with chronic hepatitis B from Jan 2010 to Oct 2024 Receives: Device: MRE; Device: Liver biopsy | |
| Prospective follow-up cohort of patients confirmed diagnosed with chronic hepatitis B | Patients aged ≥ 18 who have been diagnosed with chronic hepatitis B, both treated and untreated from Aug 2022 Receives: Device: MRE; Device: Liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the features of MRE for grading fibrosis in chronic hepatitis B.
WIth liver biopsy as reference standand, the diagnostic perforemace (accuracy) for fibrosis of MRE was assessed.
Measured: 6 months
Secondary outcomes (2)
The efficacy of grading liver fibrosis in CHB patients evaluated by MRE superior to TE and serological indicators (APRI, FIB-4).
WIth liver biopsy as reference standand, the efficacy of MRE, TE and serological indicators (APRI, FIB-4) in evaluating the classification of liver fibrosis were compared.
Measured: 6 months
The excellent ability of MRE as a non-invasive biomarker for longitudinal monitoring in CHB patients.
WIth QIBA Profile: Magnetic Resonance Elastography of the Liver as reference standand, changes in MRE and liver histology or clinical indicators during follow-up were investigated.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Jan 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Shengjing 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Shi, Shengjing Hospital
- Investigators
- Yu Shi, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779058
- Sponsor's protocol ID
- ShengjingH CHB 2501
- Status last verified
- Feb 2026
- First submitted
- 10 Jan 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Multi-center Clinical Study of Magnetic Resonance Elastography in Evaluating Hepatic Fibrosis in Chronic Viral Hepatitis B
- ClinicalTrials.gov ID
- NCT06779058
- Acronym / sponsor ID
- ShengjingH CHB 2501
- Conditions
- Chronic Hepatitis B, Liver Fibrosis
- Keywords
- Magnetic resonance elastography, Liver stiffness, Antiviral therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Jan 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.
How to construct a non-invasive, accurate, and convenient method to evaluate the severity of liver fibrosis (LF) is an important general problem in the management of patients with chronic hepatitis B (CHB). We plan to investigate the ability of magnetic resonance elastography (MRE) to grade fibrosis in chronic hepatitis B and apply to clinical longitudinal follow-up.
Detailed description
Hepatitis B virus (HBV) infection is the most prevalent chronic viral infection worldwide, affecting 254 million people and resulting in 1.2 million new infections annually . Chronic hepatitis B (CHB) is strongly associated with liver fibrosis, cirrhosis, hepatocellular carcinoma, and death. Patients with chronic hepatitis C (CHC) can achieve an overall cure rate of more than 95% after 12 weeks of treatment with direct-acting antiviral agent (DAA). However, patients with chronic hepatitis B still need long-term management due to the complexity and persistence of their disease. Therefore, rapid, stable and accurate assessment of the disease status of hepatitis B patients and clear classification of liver fibrosis are of great significance for clinical management of chronic hepatitis B patients.
Meanwhile, Antiviral therapy can significantly slow liver disease progression and improve long-term survival in CHB patients. Treatment is only recommended for CHB adults when histological evidences ≥ F2; evidence of F4 based on clinical criteria; HBV DNA > 2000 IU/mL with ALT > ULN (Men: 30 U/L, Women: 19 U/L); or persistent ALT abnormality. For treated patients, imaging and clinical indicators are monitored every six months during the first year, then annually. For untreated patients, monitoring is conducted on an annual basis . However, these current tests often fail to reflect pathological changes in real-time, as they tend to lag behind actual disease progression. Therefore, finding an effective method for regular follow-up is also essential for both treated and untreated patients.
The current diagnostic gold standard, liver biopsy, has limitations due to its invasive nature, sampling error, complications, and high cost, making it impractical for evaluating liver fibrosis and longitudinal monitoring in CHB patients. There is an urgent need for noninvasive evaluation of liver fibrosis and antiviral treatment efficacy. Magnetic resonance elastography (MRE) has shown promise in assessing liver fibrosis and necroinflammation in CHB patients. At present, there are few studies on CHB, all of which are single-center studies. The reported cut-off point is not uniform, which is generally lower than the international standard, and whether 2D/3D MRE affects the threshold are inconsistent. Therefore, a multi-center clinical study on the evaluation of CHB fibrosis based on MRE and its application in clinical longitudinal follow-up need to be carried out.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort of patients confirmed diagnosed with chronic hepatitis B | – | Device: MRE, Device: Liver biopsyPatients aged ≥ 18 who have been diagnosed with chronic hepatitis B from Jan 2010 to Oct 2024 |
| Prospective follow-up cohort of patients confirmed diagnosed with chronic hepatitis B | – | Device: MRE, Device: Liver biopsyPatients aged ≥ 18 who have been diagnosed with chronic hepatitis B, both treated and untreated from Aug 2022 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Organize paticipating units to collect standard-of-care data including radiological and clinical data. Patients diagnosed with CHB who received liver biopsy and MRE should be enrolled.
Key inclusion criteria (6 listed)
- Age ≥ 18 years old
- Confirmed CHB (laboratory, imaging and clinical tests)
- MRE within 6 months before and after liver biopsy
- Treatment-naïve
- Child-Pugh Grade A (<7 points)
Key exclusion criteria (6 listed)
- Patients with liver malignant tumor
- Chronic hepatitis due to other causes (such as alcoholic hepatitis)
- CHB combined with hepatitis C, hepatitis D, or HIV
- Patients with biliary tract diseases
- Contraindications of MRE examination, MRE failure
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 |
|---|---|---|
| MREAll imaging studies were performed by using a 1.5T/3.0-T MRI system | Device | Prospective follow-up cohort of patients confirmed diagnosed with chronic hepatitis B, Retrospective cohort of patients confirmed diagnosed with chronic hepatitis B |
| Liver biopsyLiver biopsy are performed by well-trained pathologists in accordance with standard operating procedures. | Device | Prospective follow-up cohort of patients confirmed diagnosed with chronic hepatitis B, Retrospective cohort of patients confirmed diagnosed with chronic hepatitis B |
Primary outcome
Accuracy of the features of MRE for grading fibrosis in chronic hepatitis B.
Time frame: 6 months
WIth liver biopsy as reference standand, the diagnostic perforemace (accuracy) for fibrosis of MRE was assessed.
2 secondary outcomes
The efficacy of grading liver fibrosis in CHB patients evaluated by MRE superior to TE and serological indicators (APRI, FIB-4).
Time frame: 6 months
The excellent ability of MRE as a non-invasive biomarker for longitudinal monitoring in CHB patients.
Time frame: 12 months
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 27 Feb 2026.
- 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.
Yu Shi principal investigator
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B and Liver Fibrosis, run by Shengjing 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 6 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 27 Feb 2026. 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.
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 Yiyang Wang (+86 15291014907, 15291014907@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the features of MRE for grading fibrosis in chronic hepatitis B. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.