HBVNCT06746701
Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA.
An observational study of HBV, run by Xiangya Hospital of Central South University at 4 sites in China.
Trial summary
This is a retrospective prospective, open-label, multicenter clinical study aiming to recruit 400 individuals with a family history of liver cancer to explore the clinical cure rate and the effectiveness, feasibility, and safety of PEGylated interferon α-2b combined with nucleos(t)ide analogues in treating chronic HBV… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HBV
- What is being tested?
- Peg-IFNα-2b combined with NA and Nucleotide Analogues
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 400 participants
- Where
- 4 sitesChina
- Study dates
- 25 May 2023to 25 May 2029
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Select chronic HBV carriers with a family history of liver cancer from each center.
Who may be able to join
- Age18-65 years (inclusive of 18 and 65), no restriction on gender;
- HBsAg positive history for at least 6 months;
- Family history of liver cancer [including first-degree and second-degree relatives; first-degree relatives are parents, children, and siblings (same parents), while second-degree relatives are uncles, aunts, grandparents, and great-grandparents; a family history of liver cancer means that one or more first-degree or second-degree relatives have had liver cancer];
- Planning to or already receiving treatment with Peginterferon alpha-2b in combination with nucleoside (acid) analogs, or receiving nucleoside (acid) analogs treatment alone;
- Negative urine or serum pregnancy test within 24 hours before the first dose (for women of childbearing age);
- Willing to receive treatment and sign an informed consent form.
Who cannot join
- Allergy to interferon;
- History of using telbivudine for antiviral treatment;
- ALT(Alanine Aminotransferase) greater than 10 times the upper limit of normal, total bilirubin greater than 2 times the upper limit of normal;
- Decompensated liver cirrhosis;
- Neutrophil count < 1.5 x 10^9/L or platelet count < 80 x 10^9/L;
- Presence of severe lesions in vital organs such as the cardiovascular, pulmonary, renal, brain, and fundus;
Show all 14Show fewer
- Those with autoimmune diseases, psychiatric disorders, poorly controlled diabetes, or thyroid dysfunction (hyperthyroidism or hypothyroidism);
- Confirmed or suspected liver cancer or other malignant tumors;
- Post-organ transplant or preparing for organ transplantation;
- Currently using immunosuppressants;
- Pregnant or planning to become pregnant within 2 years;
- Alcohol or drug addicts;
- HIV co-infection;
- Other conditions deemed unsuitable for interferon use by the attending physician.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Chenzhou Second People's Hospital
Chenzhou, Hunan
LeDu Zhou, Ph.D, 17373120367, zhould@scu.cn
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
LeDu Zhou, Ph.D, 17373120367, zhould@scu.cn
- Recruiting
First Affiliated Hospital of Nanhua University
Hengyang, Hunan
LeDu Zhou, 17373120367, zhould@scu.cn
- Recruiting
Hengyang Third People's Hospital
Hengyang, Hunan
LeDu Zhou, Ph.D, 17373120367, zhould@scu.cn
About this study
Official title: Investigating the Clinical Cure Rate and the Risk Reduction of Hepatocellular Carcinoma in Chronic HBV Infected Individuals With a Family History of Liver Cancer Using PegIFN α-2b Combined With NA Treatment in a Real-world Study.
This is a retrospective prospective, open-label, multicenter clinical study aiming to recruit 400 individuals with a family history of liver cancer to explore the clinical cure rate and the effectiveness, feasibility, and safety of PEGylated interferon α-2b combined with nucleos(t)ide analogues in treating chronic HBV carriers with a family history of liver cancer for reducing the risk of liver cancer occurrence. Patients will enrolled into Group A (Peg-IFNα-2b combined with NA treatment group) or Group B (NA monotherapy group) based on their medication choices. Each group is expected to enroll 200 patients, with all patients followed up to 240 weeks. The dosage, frequency, and duration of treatment with Peg-IFN α-2b and NA will be prescribed by the researchers according to clinical practice and standard treatment protocols.
- Conditions
- HBV
- Being tested
- Peg-IFNα-2b combined with NA, Nucleotide Analogues
- Keywords
- Peginterferon α-2b injection, Nucleotide Analogues, HBV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peg-IFNα-2b combined with NADrug
From baseline day 1, take NA orally once daily until the drug can be discontinued. Concurrently, combine with Peg-IFN α-2b 180μg, administered subcutaneously once a week for 48-96 weeks (if the surface antigen is not converted to negative at week 48, continue Peg-IFN α-2b treatment, but the course of treatment should not exceed 96 weeks). Discontinue Peg-IFN α-2b (while maintaining continuous oral administration of NA), and continue taking NA orally.
Nucleotide AnaloguesDrug
Starting from the first day of enrollment, take NA orally once a day.
| Study group | Role | What they receive |
|---|---|---|
| Peg-IFNα-2b combined with NA | Not described Receives: Drug: Peg-IFNα-2b combined with NA | |
| NA monotherapy | Not described Receives: Drug: Nucleotide Analogues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate
The definition of a cure is: maintaining HBsAg(Hepatitis B surface antigen) negativity (with or without the appearance of anti-HBs), undetectable HBV DNA, normal liver biochemical indices, and improvement in liver tissue lesions after discontinuation of treatment.
Measured: through study completion, an average of 24 weeks.
Liver cancer incidence rate
Measured: through study completion, an average of 24 weeks.
Secondary outcomes (7)
The decrease in HBsAg compared to baseline.
Measured: through study completion, an average of 24 weeks.
HBsAg seroconversion rate
Measured: through study completion, an average of 24 weeks.
Changes of biomarkers after disease progression-related markers such as HBV DNA quantification compared to baseline.
Measured: through study completion, an average of 24 weeks.
Incidence of abnormal and clinically relevant changes in vital signs
Measured: through study completion, an average of 24 weeks.
Incidence of treatment-emergent adverse event (AE)
Measured: through study completion, an average of 24 weeks.
Incidence of abnormal and clinically relevant changes in laboratory assessments
Measured: through study completion, an average of 24 weeks.
Incidence of severe acute allergic reactions occurring during treatment.
Measured: through study completion, an average of 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start25 May 2023
- Primary completion25 May 2027 (estimated)
- Study completion25 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBVStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LeDu Zhou, Ph.D, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746701
- Sponsor's protocol ID
- 202207428
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 24 Dec 2024
- 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 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Clinical Cure Rate and the Risk Reduction of Hepatocellular Carcinoma in Chronic HBV Infected Individuals With a Family History of Liver Cancer Using PegIFN α-2b Combined With NA Treatment in a Real-world Study.
- ClinicalTrials.gov ID
- NCT06746701
- Acronym / sponsor ID
- 202207428
- Conditions
- HBV
- Keywords
- Peginterferon α-2b injection, Nucleotide Analogues, HBV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 25 May 2027 (estimated)
- Study completion
- 25 May 2029 (estimated)
- First posted
- 24 Dec 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 is a retrospective prospective, open-label, multicenter clinical study aiming to recruit 400 individuals with a family history of liver cancer to explore the clinical cure rate and the effectiveness, feasibility, and safety of PEGylated interferon α-2b combined with nucleos(t)ide analogues in treating chronic HBV carriers with a family history of liver cancer for reducing the risk of liver cancer occurrence. Patients will enrolled into Group A (Peg-IFNα-2b combined with NA treatment group) or Group B (NA monotherapy group) based on their medication choices. Each group is expected to enroll 200 patients, with all patients followed up to 240 weeks. The dosage, frequency, and duration of treatment with Peg-IFN α-2b and NA will be prescribed by the researchers according to clinical practice and standard treatment protocols.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peg-IFNα-2b combined with NA | – | Drug: Peg-IFNα-2b combined with NA |
| NA monotherapy | – | Drug: Nucleotide Analogues |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Select chronic HBV carriers with a family history of liver cancer from each center.
Key inclusion criteria (6 listed)
- Age18-65 years (inclusive of 18 and 65), no restriction on gender;
- HBsAg positive history for at least 6 months;
- Family history of liver cancer [including first-degree and second-degree relatives; first-degree relatives are parents, children, and siblings (same parents), while second-degree relatives are uncles, aunts, grandparents, and great-grandparents; a family history of liver cancer means that one or more first-degree or second-degree relatives have had liver cancer];
- Planning to or already receiving treatment with Peginterferon alpha-2b in combination with nucleoside (acid) analogs, or receiving nucleoside (acid) analogs treatment alone;
- Negative urine or serum pregnancy test within 24 hours before the first dose (for women of childbearing age);
Key exclusion criteria (14 listed)
- Allergy to interferon;
- History of using telbivudine for antiviral treatment;
- ALT(Alanine Aminotransferase) greater than 10 times the upper limit of normal, total bilirubin greater than 2 times the upper limit of normal;
- Decompensated liver cirrhosis;
- Neutrophil count < 1.5 x 10^9/L or platelet count < 80 x 10^9/L;
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-IFNα-2b combined with NAFrom baseline day 1, take NA orally once daily until the drug can be discontinued. Concurrently, combine with Peg-IFN α-2b 180μg, administered subcutaneously once a week for 48-96 weeks (if the surface antigen is not converted to negative at week 48, continue Peg-IFN α-2b treatment, but the course of treatment should not exceed 96 weeks). Discontinue Peg-IFN α-2b (while maintaining continuous oral administration of NA), and continue taking NA orally. | Drug | Peg-IFNα-2b combined with NA |
| Nucleotide AnaloguesStarting from the first day of enrollment, take NA orally once a day. | Drug | NA monotherapy |
Primary outcome
Clinical cure rate
Time frame: through study completion, an average of 24 weeks.
The definition of a cure is: maintaining HBsAg(Hepatitis B surface antigen) negativity (with or without the appearance of anti-HBs), undetectable HBV DNA, normal liver biochemical indices, and improvement in liver tissue lesions after discontinuation of treatment.
Liver cancer incidence rate
Time frame: through study completion, an average of 24 weeks.
7 secondary outcomes
The decrease in HBsAg compared to baseline.
Time frame: through study completion, an average of 24 weeks.
HBsAg seroconversion rate
Time frame: through study completion, an average of 24 weeks.
Changes of biomarkers after disease progression-related markers such as HBV DNA quantification compared to baseline.
Time frame: through study completion, an average of 24 weeks.
Incidence of abnormal and clinically relevant changes in vital signs
Time frame: through study completion, an average of 24 weeks.
Incidence of treatment-emergent adverse event (AE)
Time frame: through study completion, an average of 24 weeks.
Incidence of abnormal and clinically relevant changes in laboratory assessments
Time frame: through study completion, an average of 24 weeks.
Incidence of severe acute allergic reactions occurring during treatment.
Time frame: through study completion, an average of 24 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 24 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for HBV
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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.
LeDu Zhou, Ph.D principal investigator
Xiangya Hospital of Central South University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HBV, run by Xiangya Hospital of Central South University at 4 sites 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 6 inclusion and 14 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 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 LeDu Zhou, Ph.D (17373120367, zhould@scu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure rate (time frame: through study completion, an average of 24 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 24 Dec 2024.