Chronic Hepatitis BNCT06696664
Exploring the Genome-wide Association Study of the Population With Clinical Cure Advantage in the Treatment of Chronic Hepatitis B With Long-acting Interferon
An observational study of Chronic Hepatitis B, run by Minghui Li at 1 site in China.
Trial summary
This study is a real-world case-control study conducted, with 120 CHB patients who received continuous treatment with PEG-IFN-α for more than 24 weeks as study subjects. Among them, the clinical cure group obtained through PEG-IFN-α treatment is the case group; The group that did not achieve clinical cure after… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- PEG-IFN-α
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Mar 2026
- How long will I take part?
- 96 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Adult, Older adult
Study population: Collect blood samples from CHB patients who have completed PEG-IFN - α continuous treatment for more than 24 weeks (two groups of CHB patients who have obtained and have not obtained clinical cure after PEG-IFN - α treatment), to provide samples for sequencing candidate genes.
Who may be able to join
- 18 years old ≤ age ≤ 70 years old, Han ethnicity, gender not limited;
- According to the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022)", patients with HBsAg and/or HBV DNA positivity for more than 6 months and chronic inflammatory liver disease caused by persistent HBV infection are diagnosed with chronic hepatitis B (CHB);
- The patient receives subcutaneous injections of PEG-IFN-α for at least 24 consecutive weeks;
- Patients voluntarily sign an informed consent form before the start of the study.
Who cannot join
- Patients with co infection of HCV, HDV, HIV, and Treponema pallidum;
- Patients with evidence of alcohol abuse, decompensated cirrhosis, liver tumors (liver cancer or AFP>100 ng/ml), or autoimmune diseases.
- Patients who become pregnant during PEG-IFN - α treatment;
- Other situations that the patient deems unsuitable for inclusion in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015
Minghui Li, Dr, +8613693259096, wuhm2000@sina.com
About this study
Official title: Exploring the Genome-wide Association Study of the Advantageous Population for Clinical Cure of Chronic Hepatitis B With Long-acting Interferon Therapy
This study is a real-world case-control study conducted, with 120 CHB patients who received continuous treatment with PEG-IFN-α for more than 24 weeks as study subjects. Among them, the clinical cure group obtained through PEG-IFN-α treatment is the case group; The group that did not achieve clinical cure after PEG-IFN-α treatment was used as the control group, and the case group and control group were allocated cases in a 2:1 ratio. Collect blood samples from subjects as sequencing samples for candidate genes, use high-throughput sequencing technology to detect the whole genome of subjects, identify relevant genetic polymorphism that have predictive value for clinical cure of chronic hepatitis B treated with PEG-IFN-α, and establish a predictive model and calculation formula between gene polymorphism and the efficacy of PEG-IFN-α antiviral therapy.
Read the detailed description
This study is a real-world case-control study conducted on 120 patients with chronic hepatitis B (CHB) who were continuously treated with pegylated interferon-α (PEG-IFN-α) for more than 24 weeks. Among them, the clinical cure group obtained through PEG-IFN-α treatment is the case group; The group that did not achieve clinical cure after PEG-IFN-α treatment was used as the control group, and the case group and control group were allocated cases in a 2:1 ratio. Collect blood samples as candidate gene sequencing samples, use high-throughput sequencing technology to detect the whole genome of the subjects, identify relevant genetic polymorphism that have predictive value for clinical cure of chronic hepatitis B with PEG-IFN-α therapy, and establish a predictive model and calculation formula between gene polymorphism and the efficacy of PEG-IFN-α antiviral therapy.
- Conditions
- Chronic Hepatitis B
- Being tested
- PEG-IFN-α
- Keywords
- chronic hepatitis B, pegylated interferon-α, clinical cure, gene sequencing, genetic polymorphism
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-IFN-αDrug
chronic hepatitis B (CHB) who were continuously treated with pegylated interferon (PEG-IFN - α) for more than 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Case group | Case group (HBsAg negative conversion group): 120 CHB patients who achieved clinical cure after continuous treatment with PEG-IFN-α for more than 24 weeks. Receives: Drug: PEG-IFN-α | |
| Control group | Control group: 300 CHB patients who were continuously treated with PEG-IFN - α for more than 24 weeks without clinical cure. Receives: Drug: PEG-IFN-α |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure
HBsAg negative, with or without the presence of anti HBs, HBV DNA below the lower limit of detection, ALT<lower limit of normal value
Measured: 96 weeks
Non clinical cure
Non clinical cure (partially effective and ineffective): HBsAg has not turned negative Partially effective: HBV DNA is below the lower limit of detection, ALT is below the lower limit of normal. Invalid: Not partially valid.
Measured: 96 weeks
Secondary outcomes (4)
HBV DNA turns negative
HBV DNA suppression (HBV DNA below the detection limit or not detected);
Measured: 96 weeks
HBeAg conversion to negative
HBeAg conversion to negative (disappearance of HBeAg in patients with previous HBeAg positivity).
Measured: 96 weeks
HBsAg re positivity rate
Hepatitis B surface antigen re positive rate after PEG-IFN-α withdrawal
Measured: 96 weeks
Improvement in liver function
Liver function status after PEG-IFN-α treatment
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Aug 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 96 Weeks
Sponsor and investigators
- Lead sponsor
- Minghui Li
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Minghui Li, Beijing Municipal Administration of Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696664
- Sponsor's protocol ID
- BTP-CHB04
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- 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 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Genome-wide Association Study of the Advantageous Population for Clinical Cure of Chronic Hepatitis B With Long-acting Interferon Therapy
- ClinicalTrials.gov ID
- NCT06696664
- Acronym / sponsor ID
- BTP-CHB04
- Conditions
- Chronic Hepatitis B
- Keywords
- chronic hepatitis B, pegylated interferon-α, clinical cure, gene sequencing, genetic polymorphism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Minghui LiOther government
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 20 Nov 2024 (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.
This study is a real-world case-control study conducted, with 120 CHB patients who received continuous treatment with PEG-IFN-α for more than 24 weeks as study subjects. Among them, the clinical cure group obtained through PEG-IFN-α treatment is the case group; The group that did not achieve clinical cure after PEG-IFN-α treatment was used as the control group, and the case group and control group were allocated cases in a 2:1 ratio. Collect blood samples from subjects as sequencing samples for candidate genes, use high-throughput sequencing technology to detect the whole genome of subjects, identify relevant genetic polymorphism that have predictive value for clinical cure of chronic hepatitis B treated with PEG-IFN-α, and establish a predictive model and calculation formula between gene polymorphism and the efficacy of PEG-IFN-α antiviral therapy.
Detailed description
This study is a real-world case-control study conducted on 120 patients with chronic hepatitis B (CHB) who were continuously treated with pegylated interferon-α (PEG-IFN-α) for more than 24 weeks. Among them, the clinical cure group obtained through PEG-IFN-α treatment is the case group; The group that did not achieve clinical cure after PEG-IFN-α treatment was used as the control group, and the case group and control group were allocated cases in a 2:1 ratio. Collect blood samples as candidate gene sequencing samples, use high-throughput sequencing technology to detect the whole genome of the subjects, identify relevant genetic polymorphism that have predictive value for clinical cure of chronic hepatitis B with PEG-IFN-α therapy, and establish a predictive model and calculation formula between gene polymorphism and the efficacy of PEG-IFN-α antiviral therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 96 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Drug: PEG-IFN-αCase group (HBsAg negative conversion group): 120 CHB patients who achieved clinical cure after continuous treatment with PEG-IFN-α for more than 24 weeks. |
| Control group | – | Drug: PEG-IFN-αControl group: 300 CHB patients who were continuously treated with PEG-IFN - α for more than 24 weeks without clinical cure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Collect blood samples from CHB patients who have completed PEG-IFN - α continuous treatment for more than 24 weeks (two groups of CHB patients who have obtained and have not obtained clinical cure after PEG-IFN - α treatment), to provide samples for sequencing candidate genes.
Key inclusion criteria (4 listed)
- 18 years old ≤ age ≤ 70 years old, Han ethnicity, gender not limited;
- According to the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022)", patients with HBsAg and/or HBV DNA positivity for more than 6 months and chronic inflammatory liver disease caused by persistent HBV infection are diagnosed with chronic hepatitis B (CHB);
- The patient receives subcutaneous injections of PEG-IFN-α for at least 24 consecutive weeks;
- Patients voluntarily sign an informed consent form before the start of the study.
Key exclusion criteria (4 listed)
- Patients with co infection of HCV, HDV, HIV, and Treponema pallidum;
- Patients with evidence of alcohol abuse, decompensated cirrhosis, liver tumors (liver cancer or AFP>100 ng/ml), or autoimmune diseases.
- Patients who become pregnant during PEG-IFN - α treatment;
- Other situations that the patient deems unsuitable for inclusion in this trial.
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 |
|---|---|---|
| PEG-IFN-αchronic hepatitis B (CHB) who were continuously treated with pegylated interferon (PEG-IFN - α) for more than 24 weeks | Drug | Case group, Control group |
Primary outcome
Clinical cure
Time frame: 96 weeks
HBsAg negative, with or without the presence of anti HBs, HBV DNA below the lower limit of detection, ALT<lower limit of normal value
Non clinical cure
Time frame: 96 weeks
Non clinical cure (partially effective and ineffective): HBsAg has not turned negative Partially effective: HBV DNA is below the lower limit of detection, ALT is below the lower limit of normal. Invalid: Not partially valid.
4 secondary outcomes
HBV DNA turns negative
Time frame: 96 weeks
HBeAg conversion to negative
Time frame: 96 weeks
HBsAg re positivity rate
Time frame: 96 weeks
Improvement in liver function
Time frame: 96 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- 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.
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 Chronic Hepatitis B, run by Minghui Li 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weihua Cao, Dr (18811333129, weihuacaohappy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure (time frame: 96 weeks). The study lists 2 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 20 Nov 2024.