A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB

NCT ID: NCT05057065

Last Updated: 2021-09-27

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

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-06-01

Brief Summary

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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.

Detailed Description

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Primary objective:

To evaluate the impact of metabolic disease on the progression of chronic hepatitis B

* To observe HBsAg/HBeAg/HBV DNA changes /HBsAg seroconversion
* To determine high rates of Liver Cirrhosis and Hepatocellular Carcinoma

Group 1 : CHB with diabetes Group 2 : CHB with hyperlipemia Group 3 : CHB without metabolic diseases

Study Duration (in months) 24 months

Conditions

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Hepatitis B, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Hyperlipidemia

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

No interventions assigned to this group

diabetes

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

No interventions assigned to this group

CHB without metabolic disease

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hong Ren

OTHER

Sponsor Role lead

Responsible Party

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Hong Ren

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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HONG REN, Prof.

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Chongqing Medical University

Locations

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The 2nd affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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HONG REN, Prof.

Role: CONTACT

8613983888786

DACHUAN CAI, Dr.

Role: CONTACT

8613883596197

Facility Contacts

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HONG REN

Role: primary

+8613983888786

DACHUAN CAI

Role: backup

+8613883596197

Other Identifiers

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LS2021037

Identifier Type: -

Identifier Source: org_study_id

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