CClinicalTrials.gg
Status unknownNCT05057065Updated Sep 27, 2021

A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB

An observational study in Hepatitis B, Chronic, sponsored by Hong Ren. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2021-09-27.

Sponsored by Hong Ren · Observational

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10,000
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Hepatitis B, Chronic

Keywords

  • HBV
  • metabolic diseases
03

In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 390 across 407 observational studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Hong Ren is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Chronic hepatitis B patients

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

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.

    Time frame: 2 year

Secondary outcomes

  1. Incidence of liver fibrosis and cirrhosis

    We will follow up patients every six months and all patients() with a history of hepatitis B will be tested for FibroScan. The influence of metabolic diseases on the progression of hepatitis B was evaluated by comparing the changes of liver hardness between groups(Hyperlipidemia,Diabetes and CHB without metabolic disease)

    Time frame: 2 year

07

Study locations

1 of 1 sites recruiting
  • The 2nd affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing 400010, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05057065
Lead sponsor
Hong Ren
Responsible party
Hong Ren (Principal Investigator, The Second Affiliated Hospital of Chongqing Medical University) — Sponsor-investigator
First posted
Sep 27, 2021
Start date
Sep 15, 2021 (estimated)
Primary completion
Sep 1, 2022 (estimated)
Completion
Jun 1, 2023 (estimated)
Last update
Sep 27, 2021

Study contacts

HONG REN, Prof.
Contact
renhong0531@vip.sina.com
8613983888786
DACHUAN CAI, Dr.
Contact
dachuancai@yahoo.com
8613883596197
HONG REN, Prof.
principal investigator · The Second Affiliated Hospital of Chongqing Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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