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

NCT ID: NCT04032275

Last Updated: 2019-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Hepatitis B

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Chronic hepatitis B infection

Intervention Type OTHER

Chronic hepatitis B infection patients

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Chronic hepatitis B infection

Chronic hepatitis B infection patients

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 1\) Age between 18 and over 65;
* 2\) gender is not limited;
* 3\) 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;

Exclusion Criteria

* 1\) Combine other hepatitis viruses (HCV (HCV, HDV, HDV) infection;
* 2\) autoimmune liver disease;
* 3\) HIVHIV HIV infection;
* 4\) long-term alcohol abuse and / or other liver damage drugs;
* 5\) mental illness;
* 6\) Evidence of liver tumors (cancer or AFP AFP\>100 ng/ml 100 ng/ml 100 ng/ml 100 ng/ml);
* 7\) decompensated cirrhosis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Ditan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yao Xie

Head of liver diseases center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yao Xie, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Ditan Hospital, Beijing, China

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

liver disease center, Beijing Ditan Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DTXY020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.