Hepatitis B, ChronicNCT05057065
A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB
An observational study of Hepatitis B, Chronic, run by Hong Ren at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis B, Chronic
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2021to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chronic hepatitis B patients
Who may be able to join
- Chronic hepatitis B (positive HBsAg for at least 6 months prior to NA therapy start)
- Patients on-treatment with NAs
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 2nd affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
HONG REN, +8613983888786, renhong0531@vip.sina.com
DACHUAN CAI, +8613883596197, dachuancai@yahoo.com
About this study
Official title: Disease Progression and Intervention of Chronic HepatitisB Based on Diabetes and Hyperlipidemia
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
- Conditions
- Hepatitis B, Chronic
- Keywords
- HBV, metabolic diseases
- Medical subject headings
- Hepatitis B, Chronic, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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）
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start15 Sep 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Ren
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hong Ren, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- HONG REN, Prof., Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057065
- Sponsor's protocol ID
- LS2021037
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Progression and Intervention of Chronic HepatitisB Based on Diabetes and Hyperlipidemia
- ClinicalTrials.gov ID
- NCT05057065
- Acronym / sponsor ID
- LS2021037
- Conditions
- Hepatitis B, Chronic
- Keywords
- HBV, metabolic diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Hong RenUniversity, hospital or other
- Study start
- 15 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chronic hepatitis B patients
Key inclusion criteria (2 listed)
- Chronic hepatitis B (positive HBsAg for at least 6 months prior to NA therapy start)
- Patients on-treatment with NAs
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy of NAs therapy
Time frame: 2 year
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.
1 secondary outcome
Incidence of liver fibrosis and cirrhosis
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HONG REN, Prof. principal investigator
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, Chronic, run by Hong Ren at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HONG REN, Prof. (8613983888786, renhong0531@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of NAs therapy (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.