A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB

NCT05057065 | Unknown

• 1 other identifier: LS2021037
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

HBV(hepatitis B virus) with metabolic comorbidities may accelerate liver disease progression and increase the risk of HCC(Hepatocellular Carcinoma)development. It is reported combination of metabolic diseases and CHB is associated with substantially increased rates of liver cirrhosis and secondary liver-related events compared to CHB alone. Consequently, hepatitis B patients with metabolic comorbidities warrant particular attention in disease surveillance and evaluation of treatment indications.

Conditions

Hepatitis B, Chronic

Keywords

HBV; metabolic diseases

Outcome Measures

Primary Outcomes (1)

• Efficacy of NAs therapy

  We will follow up patients every six months and all patients with a history of hepatitis B will be tested for HBsAg(+) and HBD-DNA.The curative effect was evaluated by observing the changes of serological indexes.

  2 year

Secondary Outcomes (1)

• Incidence of liver fibrosis and cirrhosis

  2 year

Study Arms (3)

Hyperlipidemia

* HBsAg(+) patients * TC\>5.17mmol/L（200mg/dl）and（or）TG\>2.3mmol/L（200mg/dl）

diabetes

* HBsAg(+) patients * FPG\>126 mg/dL(7.0 mmol/L)Fasting is defined as no caloric intake for at least 8 h.

CHB without metabolic disease

* HBsAg(+) patients * without diabetes/ obesity/hyperlipidemia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic hepatitis B patients

You may qualify if:

• Chronic hepatitis B (positive HBsAg for at least 6 months prior to NA therapy start)
• Patients on-treatment with NAs

You may not qualify if:

• Treatment with immunosuppressors (including systemic corticosteroids) or anti-neoplastic treatment (including radiation therapy) \<=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
• History of depression or uncontrolled psychiatric disorders
• Subjects protected by law or not in a position to give consent

Sponsors & Collaborators

• Hong Ren: lead

Study Sites (1)

The 2nd affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic; Metabolic Diseases

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; Nutritional and Metabolic Diseases

Study Officials

• HONG REN, Prof.

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HONG REN, Prof.

CONTACT

8613983888786; renhong0531@vip.sina.com

DACHUAN CAI, Dr.

CONTACT

8613883596197; dachuancai@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 27, 2021
• Study Start: September 15, 2021
• Primary Completion: September 1, 2022
• Study Completion: June 1, 2023
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)