Chronic Hepatitis bNCT03777969
Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients
An observational study of Chronic Hepatitis b, run by Beijing Friendship Hospital at 7 sites in China.
Trial summary
A total of 2000 chronic hepatitis B (CHB) patients with liver biopsy performed at least 1 year after antiviral therapy are enrolled. All the patients will receive original antiviral treatment for the following 10 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Hepatitis b
- How many people
- 2,000 participants
- Where
- 7 sitesChina
- Study dates
- 29 Jun 2018to 31 Dec 2028
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: CHB patients with liver biopsy performed at least 1 year after antiviral therapy; or CHB patients with antiviral therapy for at least 1 year content to be performed liver biopsy at enrollment.
Who may be able to join
- No age limit;
- Male or female;
- Patients with liver biopsy performed at least 1 year after antiviral therapy; patients with history of clinical endpoint events (decompensated cirrhosis, hepatocellular carcinoma, liver transplantation or liver-related death) after liver biopsy;
- Patients with liver biopsy or liver stiffness or aspartate aminotransferase (AST)-to-platelet (PLT) ratio index (APRI) before antiviral treatment.
- No age limit;
- Male or female;
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- Patients with liver biopsy performed at least 1 year after antiviral therapy; or chronic hepatitis B (CHB) patients with antiviral therapy at least 1 year content to be performed liver biopsy at enrollment;
- Patients with liver biopsy or liver stiffness or APRI before antiviral treatment;
- Agree to be followed up regularly;
- Signature of informed consent.
Who cannot join
- Patients with decompensated cirrhosis (including ascites, hepatic encephalopathy, esophageal varices bleeding, hepatorenal syndrome, spontaneous bacterial peritonitis, or other complications of decompensated cirrhosis), hepatocellular carcinoma, or liver transplantation before liver biopsy;
- Patients with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, or other chronic liver diseases;
- Patients with malignant lesion on liver image;
- Patients with other uncured malignant tumors;
- Patients with severe heart, lung, kidney, brain, blood, neuropsychiatric or other organs diseases;
- Pregnant or lactating women;
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- Patients with any other reasons not suitable for the study.
- Group 2: Patients without history of clinical endpoint events
- Patients with decompensated cirrhosis (including ascites, hepatic encephalopathy, esophageal varices bleeding, hepatorenal syndrome, spontaneous bacterial peritonitis, or other complications of decompensated cirrhosis), hepatocellular carcinoma, or liver transplantation;
- Patients with HCV or HIV infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, or other chronic liver diseases;
- Patients with malignant lesion on liver image;
- Patients with other uncured malignant tumors, exclude who were cured;
- Patients with severe heart, lung, kidney, brain, blood, neuropsychiatric or other organs diseases;
- Pregnant or lactating women;
- Patients with any other reasons not suitable for the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Hangzhou Choutu Technology Co.,Ltd.
Hangzhou, Zhejiang
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality
Wuxi Hisky Medical Technologies Co., Ltd.
Wuxi, Jiangsu
About this study
Official title: Precise Prediction System for Clinical Endpoint Events of Chronic Hepatitis B Patients in the Ear of Antiviral Therapy
A total of 2000 chronic hepatitis B (CHB) patients with liver biopsy performed at least 1 year after antiviral therapy are enrolled. All the patients will receive original antiviral treatment for the following 10 years. Patients will be assessed at baseline and at every six months for blood count, liver function test, alpha fetoprotein (AFP), prothrombin time, liver ultrasonography, liver stiffness measurement (LSM), Hepatitis B virus (HBV) DNA and HBV serological markers. HBV-related endpoint events, including cirrhosis decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), hepatocellular carcinoma (HCC), liver transplantation and liver-related death, will be collected during follow-up.
Read the detailed description
No.
- Conditions
- Chronic Hepatitis b
- Keywords
- Chronic Hepatitis B, Liver fibrosis/cirrhosis, HBV-related endpoint events, Precise prediction model
- Medical subject headings
- Hepatitis B, Chronic, Liver Cirrhosis, Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV-related clinical endpoint events, including liver decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), HCC, liver transplantation and liver-related death
Incidence of HBV-related clinical endpoint events during follow-ups
Measured: 1 to 10 years
Secondary outcomes (3)
Predicted probability of HBV-related clinical endpoint events
The predicted probability is measured by histological prediction model or non-invasive prediction model
Measured: 1 to 10 years
Predicted probability of HBV-induced fibrosis/cirrhosis regression
The predicted probability is measured by histological prediction model or non-invasive prediction model
Measured: 1 to 10 years
Percentage of HBV-induced liver fibrosis/cirrhosis regression
Liver fibrosis regression was defined as decrease >= 1 point by Ishak fibrosis scoring system (range from 0 to 6, higher values represent a worse outcome) or Predominantly Regressive in P-I-R ( predominantly progressive, indeterminate and predominately regressive) score
Measured: 1 to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start29 Jun 2018
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Beijing Friendship 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
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Ruijin Hospital, ShuGuang Hospital, Beijing Ditan Hospital, Hangzhou Choutu Technology Co.,Ltd., Wuxi Hisky Medical Technologies Co., Ltd.
- Responsible party
- Principal investigator, Hong You, Beijing Friendship Hospital
- Investigators
- Hong You, Doctor, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777969
- Sponsor's protocol ID
- 2018ZX10302204-001
- Status last verified
- Sep 2022
- First submitted
- 27 Oct 2018
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun Y, Chen W, Chen S, Wu X, Zhang X, Zhang L, Zhao H, Xu M, Chen Y, Piao H, Li P, Li L, Jiang W, Li X, Xing H, Liu X, Zhang Y, Wang B, Zhou J, Meng T, Zhao X, Shao C, Kong Y, Zhao X, Ou X, Liu C, Jia J, You H. Regression of Liver Fibrosis in Patients on Hepatitis B Therapy Is Associated With Decreased Liver-Related Events. Clin Gastroenterol Hepatol. 2024 Mar;22(3):591-601.e3. doi: 10.1016/j.cgh.2023.11.017. Epub 2023 Nov 30.
PubMed 38040276
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precise Prediction System for Clinical Endpoint Events of Chronic Hepatitis B Patients in the Ear of Antiviral Therapy
- ClinicalTrials.gov ID
- NCT03777969
- Acronym / sponsor ID
- 2018ZX10302204-001
- Conditions
- Chronic Hepatitis b
- Keywords
- Chronic Hepatitis B, Liver fibrosis/cirrhosis, HBV-related endpoint events, Precise prediction model
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Ruijin Hospital, ShuGuang Hospital, Beijing Ditan Hospital, Hangzhou Choutu Technology Co.,Ltd., Wuxi Hisky Medical Technologies Co., Ltd.
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Dec 2018 (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.
A total of 2000 chronic hepatitis B (CHB) patients with liver biopsy performed at least 1 year after antiviral therapy are enrolled. All the patients will receive original antiviral treatment for the following 10 years. Patients will be assessed at baseline and at every six months for blood count, liver function test, alpha fetoprotein (AFP), prothrombin time, liver ultrasonography, liver stiffness measurement (LSM), Hepatitis B virus (HBV) DNA and HBV serological markers. HBV-related endpoint events, including cirrhosis decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), hepatocellular carcinoma (HCC), liver transplantation and liver-related death, will be collected during follow-up.
Detailed description
No.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CHB patients with liver biopsy performed at least 1 year after antiviral therapy; or CHB patients with antiviral therapy for at least 1 year content to be performed liver biopsy at enrollment.
Key inclusion criteria (10 listed)
- No age limit;
- Male or female;
- Patients with liver biopsy performed at least 1 year after antiviral therapy; patients with history of clinical endpoint events (decompensated cirrhosis, hepatocellular carcinoma, liver transplantation or liver-related death) after liver biopsy;
- Patients with liver biopsy or liver stiffness or aspartate aminotransferase (AST)-to-platelet (PLT) ratio index (APRI) before antiviral treatment.
- No age limit;
Key exclusion criteria (15 listed)
- Patients with decompensated cirrhosis (including ascites, hepatic encephalopathy, esophageal varices bleeding, hepatorenal syndrome, spontaneous bacterial peritonitis, or other complications of decompensated cirrhosis), hepatocellular carcinoma, or liver transplantation before liver biopsy;
- Patients with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, or other chronic liver diseases;
- Patients with malignant lesion on liver image;
- Patients with other uncured malignant tumors;
- Patients with severe heart, lung, kidney, brain, blood, neuropsychiatric or other organs diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HBV-related clinical endpoint events, including liver decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), HCC, liver transplantation and liver-related death
Time frame: 1 to 10 years
Incidence of HBV-related clinical endpoint events during follow-ups
3 secondary outcomes
Predicted probability of HBV-related clinical endpoint events
Time frame: 1 to 10 years
Predicted probability of HBV-induced fibrosis/cirrhosis regression
Time frame: 1 to 10 years
Percentage of HBV-induced liver fibrosis/cirrhosis regression
Time frame: 1 to 10 years
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 6 Sep 2022.
- Derived from this study: PubMed 38040276Sun Y, Chen W, Chen S, Wu X, Zhang X, Zhang L, Zhao H, Xu M, Chen Y, Piao H, Li P, Li L, Jiang W, Li X, Xing H, Liu X, Zhang Y, Wang B, Zhou J, Meng T, Zhao X, Shao C, Kong Y, Zhao X, Ou X, Liu C, Jia J, You H. Regression of Liver Fibrosis in Patients on Hepatitis B Therapy Is Associated With Decreased Liver-Related Events. Clin Gastroenterol Hepatol. 2024 Mar;22(3):591-601.e3. doi: 10.1016/j.cgh.2023.11.017. Epub 2023 Nov 30.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hong You, Doctor principal investigator
Beijing Friendship Hospital
7 sites 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, run by Beijing Friendship Hospital at 7 sites 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 10 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBV-related clinical endpoint events, including liver decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), HCC, liver transplantation and liver-related death (time frame: 1 to 10 years). 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 NCT03777969, which also lists 1 linked publication.
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 6 Sep 2022.