NCT03777969Active, not recruiting
Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients
Precise Prediction System for Clinical Endpoint Events of Chronic Hepatitis B Patients in the Ear of Antiviral Therapy
Source: ClinicalTrials.gov · Last updated 6 Sept 2022
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 27 Oct 2018
- Start date
- 29 Jun 2018
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Beijing Friendship Hospital
- Diseases
- Hepatitis B
- NCT number
- NCT03777969
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 29 Jun 2018 to the primary completion date, 31 Dec 2028
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- 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;
Other
- Pregnant or lactating women;
- Pregnant or lactating women;
- Patients with any other reasons not suitable for the study.
Who the study is looking for
- 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;
- 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.
Criteria the registry did not label
- Group 1: Patients with history of HBV-related clinical endpoint events
Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Hangzhou Choutu Technology Co.,Ltd. Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Wuxi Hisky Medical Technologies Co., Ltd. Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.