Hepatitis B Virus InfectionNCT05392387
Treatment and Prognosis of Patients With Chronic HBV Infection
An observational study of Hepatitis B Virus Infection, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Hepatitis B virus (HBV) infection is a major global health issue with 257 million chronically infected individuals. Of note, China has the largest population accounting for one third of the world's infected population. Approximately, about 300 000 people die each year due to the consequences of HBV. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B Virus Infection
- What is being tested?
- Standard antiviral therapy
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2021to 25 Oct 2026
- How long will I take part?
- 3 Years
- 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 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The chronic HBV-infected patients with differential antiviral strategies were recruited and separated to peg-IFN-alpha alone, NAs alone or combination treatment groups according to their antiviral therapies. The clinical outcomes of patients with differential treatments were compared during the follow-up management.
Who may be able to join
- patients with evidence of chronic HBV infection
Who cannot join
- chronic liver injury mainly caused by other reasons, such as autoimmune diseases, alcohol, drugs and so on.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Infectious Disease, Xiangya Hospital, Central South University
Changsha, Hunan, 410008
Yan Huang, +86 13874854142, ganrankedrhyan@163.com
About this study
Official title: Study on the Antiviral Therapy and Prognosis of Patients With Chronic HBV Infection
Hepatitis B virus (HBV) infection is a major global health issue with 257 million chronically infected individuals. Of note, China has the largest population accounting for one third of the world's infected population. Approximately, about 300 000 people die each year due to the consequences of HBV. In 2016, the World Health Organization (WHO) proposed the goal for elimination of hepatitis B as public health threat by 2030 and China will be a major contributor towards this global goal. Currently, two approved therapeutic strategies are available including pegylated interferon (IFN) or nucleos (t) ide analogues (NA), which could suppress HBV replication and slow disease progression. Here, investigators hope to launch a cohort study to reveal the clinical features relating to therapeutic efficacy of antiviral therapy and the prognosis of patients with differential therapeutic strategies.
Read the detailed description
Patients with chronic HBV infection were recruited in the current study and divided in to peg-IFN-alpha alone group, NAs alone group and the combination therapy group. The serum HBV DNA level, HBV serological test and biochemical examination including serum transaminase level and AFP were recorded every three or six months. The serum, feces, urine and liver (if necessary) samples were collected during follow-up. And the clinical outcomes of patients were evaluated. The clinical and biological features of patients with different clinical outcomes will be compared to explore the factors affecting the antiviral therapeutic efficacy.
- Conditions
- Hepatitis B Virus Infection
- Being tested
- Standard antiviral therapy
- Keywords
- Hepatitis B Virus Infection, antiviral therapy, prognosis
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard antiviral therapyOther
pegylated interferon or/and nucleos(t)ide analogues
| Study group | Role | What they receive |
|---|---|---|
| peg-IFN-alpha alone | Patients with chronic HBV infection only treated with peg-IFN-alpha Receives: Other: Standard antiviral therapy | |
| nucleos(t)ide analogues alone | Patients with chronic HBV infection only treated with nucleos(t)ide analogues Receives: Other: Standard antiviral therapy | |
| combination | Patients with chronic HBV infection treated with nucleos(t)ide analogues and peg-IFN-alpha Receives: Other: Standard antiviral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
virological response
serum HBV DNA level below the detection limit
Measured: 3 years
HBeAg seroconversion
Loss of HBeAg and presence of anti-hepatitis B e antibody (anti-HBe) in a person who was previously HBeAg-positive and anti-HBe-negative
Measured: 3 years
Clinical cure
Sustained virological response and HBsAg clearance or with anti-HBs seroconversion, alanine aminotransferase (ALT) within the normal range, and mild or no lesions in the liver
Measured: 3 years
Secondary outcomes (4)
HBV DNA
The serum HBV DNA level will be detected and reported every 3 to 6 months
Measured: 3 years
HBV serological test
HBV serological markers include HBsAg, anti-HBs, HBeAg, anti-HBe, hepatitis B core antibody (anti-HBc) were detected and reported every 3 months
Measured: 3 years
liver function
The serum levels of transaminase including ALT and aspartate aminotransferase (AST) will be collected and reported every 3 months
Measured: 3 years
Alpha-fetoprotein (AFP)
The serum AFP level will be detected and reported every 3 to 6 months
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start25 Oct 2021
- Primary completion25 Oct 2024 (estimated)
- Study completion25 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B Virus InfectionStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Huang, MD, Xiangya Hospital of Central South University
- Investigators
- Yan Huang, Study director, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392387
- Sponsor's protocol ID
- Xiangya HBV project
- Status last verified
- May 2022
- First submitted
- 17 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Antiviral Therapy and Prognosis of Patients With Chronic HBV Infection
- ClinicalTrials.gov ID
- NCT05392387
- Acronym / sponsor ID
- Xiangya HBV project
- Conditions
- Hepatitis B Virus Infection
- Keywords
- Hepatitis B Virus Infection, antiviral therapy, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 25 Oct 2024 (estimated)
- Study completion
- 25 Oct 2026 (estimated)
- First posted
- 26 May 2022 (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.
Hepatitis B virus (HBV) infection is a major global health issue with 257 million chronically infected individuals. Of note, China has the largest population accounting for one third of the world's infected population. Approximately, about 300 000 people die each year due to the consequences of HBV. In 2016, the World Health Organization (WHO) proposed the goal for elimination of hepatitis B as public health threat by 2030 and China will be a major contributor towards this global goal. Currently, two approved therapeutic strategies are available including pegylated interferon (IFN) or nucleos (t) ide analogues (NA), which could suppress HBV replication and slow disease progression. Here, investigators hope to launch a cohort study to reveal the clinical features relating to therapeutic efficacy of antiviral therapy and the prognosis of patients with differential therapeutic strategies.
Detailed description
Patients with chronic HBV infection were recruited in the current study and divided in to peg-IFN-alpha alone group, NAs alone group and the combination therapy group. The serum HBV DNA level, HBV serological test and biochemical examination including serum transaminase level and AFP were recorded every three or six months. The serum, feces, urine and liver (if necessary) samples were collected during follow-up. And the clinical outcomes of patients were evaluated. The clinical and biological features of patients with different clinical outcomes will be compared to explore the factors affecting the antiviral therapeutic efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| peg-IFN-alpha alone | – | Other: Standard antiviral therapyPatients with chronic HBV infection only treated with peg-IFN-alpha |
| nucleos(t)ide analogues alone | – | Other: Standard antiviral therapyPatients with chronic HBV infection only treated with nucleos(t)ide analogues |
| combination | – | Other: Standard antiviral therapyPatients with chronic HBV infection treated with nucleos(t)ide analogues and peg-IFN-alpha |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The chronic HBV-infected patients with differential antiviral strategies were recruited and separated to peg-IFN-alpha alone, NAs alone or combination treatment groups according to their antiviral therapies. The clinical outcomes of patients with differential treatments were compared during the follow-up management.
Key inclusion criteria (1 listed)
- patients with evidence of chronic HBV infection
Key exclusion criteria (1 listed)
- chronic liver injury mainly caused by other reasons, such as autoimmune diseases, alcohol, drugs and so on.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard antiviral therapypegylated interferon or/and nucleos(t)ide analogues | Other | combination, nucleos(t)ide analogues alone, peg-IFN-alpha alone |
Primary outcome
virological response
Time frame: 3 years
serum HBV DNA level below the detection limit
HBeAg seroconversion
Time frame: 3 years
Loss of HBeAg and presence of anti-hepatitis B e antibody (anti-HBe) in a person who was previously HBeAg-positive and anti-HBe-negative
Clinical cure
Time frame: 3 years
Sustained virological response and HBsAg clearance or with anti-HBs seroconversion, alanine aminotransferase (ALT) within the normal range, and mild or no lesions in the liver
4 secondary outcomes
HBV DNA
Time frame: 3 years
HBV serological test
Time frame: 3 years
liver function
Time frame: 3 years
Alpha-fetoprotein (AFP)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Yan Huang study director
Xiangya Hospital of Central South 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 Virus Infection, run by Xiangya Hospital of Central South University 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 1 inclusion and 1 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 26 May 2022. 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 Yan Huang (+86 13874854142, ganrankedrhyan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
virological response (time frame: 3 years). The study lists 3 primary outcomes in all. 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 26 May 2022.