Correlation Between Virus and Biochemical Characteristics and Liver Histological Damage in Untreated Chronic HBV Infection

NCT04032275 | Completed

• 1 other identifier: DTXY020
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a retrospective study. Enrollment study. Enrolled in the Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Department of Liver Histology, Department of Hepatology, Chronic HBV HBV infection. The data collected included patient gender, . The data collected included patient gender, . The data collected included the patient's gender, age, HBV age of infection, past family history, etc., the age of the collected subjects, the current family history, etc., the liver histopathological diagnosis information collected in the group, and the liver disease examination Clinical toxicities and indicators, including serological diagnostic information, clinical toxicities and indicators for liver disease tests, including serological diagnostic information, clinical toxicities and indicators for liver disease tests, including serum HBV DNA HBV DNAHBV DNAHBV DNA HBV DNA content, HBsAg/HBsAg/HBsAg/HBsAg/anti-HBsHBsHBs, HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/anti-HBe content, biochemical indicators coagulation function and routine data. Content, biochemical indicators, coagulation function and routine data. Content, biochemical indicators, coagulation function and routine data. Observe patient demographic data, HBV DNA HBV DNAHBV DNAHBV DNA HBV DNA content, HBsAg/HBsAg/HBsAg/HBsAg/HBsAg/anti-HBsHBsHBs, HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/anti-HBe HBe content, biochemical indicators, coagulation Correlation between function and routine, coagulation function and conventional indicators and liver histological changes. Explore the relevance of effective diagnosis of liver changes. To explore the characteristics of clinical indicators that can effectively diagnose liver histopathological changes, and to provide clinical indicators for patients with chronic hepatitis B to receive timely treatment of histopathological changes, and provide important evidence for patients with chronic hepatitis B to receive timely treatment.

Conditions

Chronic Hepatitis B

Keywords

chronic hepatitis B; HBV; HBsAg; HBeAg; HBV DNA; histological examination

Outcome Measures

Primary Outcomes (1)

• the diagnostic ability of clinical indicators

  Clinical indicators characterize the diagnostic ability of liver histology inflammation and fibrosis

  6 months

Study Arms (1)

Untreated chronic HBV infected person group

Enrolled in the Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Department of Liver Histology, Department of Hepatology, Chronic HBV HBV infection.

Other: Chronic hepatitis B infection

Interventions

Chronic hepatitis B infection OTHER

Chronic hepatitis B infection patients

Untreated chronic HBV infected person group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic HBVHBVHBV infection: all meet the diagnostic criteria of China's Guidelines for the Prevention and Treatment of Chronic Hepatitis B (: all meet the diagnostic criteria for the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015), HBsAg HBsAg HBsAg positive for 6 months Month;

You may qualify if:

• \) Age between 18 and over 65;
• \) gender is not limited;
• \) Patients with chronic HBVHBVHBV infection: all meet the diagnostic criteria of China's Guidelines for the Prevention and Treatment of Chronic Hepatitis B (: all meet the diagnostic criteria for the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015), HBsAg HBsAg HBsAg positive for 6 months Month;

You may not qualify if:

• \) Combine other hepatitis viruses (HCV (HCV, HDV, HDV) infection;
• \) autoimmune liver disease;
• \) HIVHIV HIV infection;
• \) long-term alcohol abuse and / or other liver damage drugs;
• \) mental illness;
• \) Evidence of liver tumors (cancer or AFP AFP\>100 ng/ml 100 ng/ml 100 ng/ml 100 ng/ml);
• \) decompensated cirrhosis.

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

liver disease center, Beijing Ditan Hospital

Beijing, Beijing Municipality, 100015, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yao Xie, Doctor

  Beijing Ditan Hospital, Beijing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of liver diseases center

Study Record Dates

• First Submitted: July 20, 2019
• First Posted: July 25, 2019
• Study Start: January 1, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: July 25, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)