Hepatitis B, ChronicNCT06196632
Development and Validation of Models to Predict Functional Cure in Patients With CHB After Peg-IFN Based Therapy
An observational study of Hepatitis B, Chronic, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Hepatitis B virus (HBV) infection is prevalent across the world. Functional cure is the optimal endpoint of antiviral therapy for chronic hepatitis B virus (HBV) infection. Currently available anti-HBV therapy includes nucleoside analogs (NAs) and peginterferon-α (Peg-IFNα). Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Peginterferon-α; Nucleoside analogs
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2024to 31 Dec 2025
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The participants were retrospectively enrolled from more than 10 hospitals in China.
Who may be able to join
- 1. Sign an informed consent form;
- 2. HBsAg (+), and the course of the disease exceeds six months;
- 3. Age range from 16 to 70 years old;
- 4. Female participants of childbearing age who had a negative pregnancy test before the trial and were able to take effective contraceptive measures;
- 5. During the treatment period, within six months after the end of treatment, the patients agrees to use contraception
Who cannot join
- 1. Patients with a known history of allergy to Peg-IFNα and NAs;
- 2. Co-infection with other virus such as HAV, HCV, HDV, HEV, HIV, etc;
- 3. Patients with liver cirrhosis or a Child Pugh score of 7 or above;
- 4. History or evidence of liver disease caused by other factors (such as autoimmune liver disease, alcoholic liver disease, non-alcoholic fatty liver disease, drug-induced hepatitis, hepatolenticular degeneration, etc.);
- 5. Pregnant or lactating women; Have a history of alcohol or drug abuse within the year prior to the trial enrollment screening;
- 6. Neutrophil count<1.5 × 109/L or hemoglobin<100g/L or platelet count<80 × 109/L; During the trial enrollment screening, serum creatinine was higher than the upper normal limit;
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- 7. A history of severe diseases in important organs and tissues such as the heart, brain, kidneys, retina, and muscles;
- 8. Having a history of mental illness or a family history of mental illness, or a Hamilton Depression Scale score greater than 7 points;
- 9. History of endocrine system or autoimmune diseases, such as thyroid disease, diabetes, systemic lupus erythematosus, sarcoidosis, autoimmune thrombocytopenic purpura, etc;
- 10. History of malignant tumors;
- 11. During the trial enrollment screening, suspicious liver malignant tumors were detected by ultrasound, or AFP was greater than 100ng/mL or AFP cannot remain stable within 3 months prior to the experiment;
- 12. Has a history of important organ transplantation;
- 13. Other diseases that researchers believe are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu hospital of Shandong University
Jinan, Shandong, 250012
Shuai Gao, MD;PhD, +86-18560088213, qilugaoshuai@sdu.edu.cn
About this study
Official title: Development and Validation of Logistic Regression Models to Predict Durable Functional Cure in Patients With Chronic Hepatitis B After Pegylated Interferon Alpha-2b Based Therapy
Hepatitis B virus (HBV) infection is prevalent across the world. Functional cure is the optimal endpoint of antiviral therapy for chronic hepatitis B virus (HBV) infection. Currently available anti-HBV therapy includes nucleoside analogs (NAs) and peginterferon-α (Peg-IFNα). Combination of Peg-IFNα and NAs, each with different mechanisms of action, is an attractive approach for treating chronic HBV infection. In this study, we aim to establish logistic regression models to predict durable functional cure in patients with CHB treated by combination of Peg-IFNα and NAs, which might be useful for clinical physicians to make personalized treatment decisions. These models will be constructed using baseline routine clinical laboratory indicators with high diagnostic accuracy. These models might be widely applicable to almost all medical institutions and will effectively promote the application of Peg IFN α plus NAs therapy in clinical work. The findings in this study might greatly improve the functional cure rate of CHB and reducing the incidence rate and mortality of HBV related end-stage liver diseases.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Peginterferon-α; Nucleoside analogs
- 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.
Peginterferon-α; Nucleoside analogsDrug
Patients with chronic hepatitis B were treated with the combination of peginterferon-α and nucleoside analogs
| Study group | Role | What they receive |
|---|---|---|
| "de novo" strategy-HBeAg positive | HBeAg positive patients treated with simultaneous administration of NA and Peg-IFN Receives: Drug: Peginterferon-α; Nucleoside analogs | |
| "de novo" strategy-HBeAg negative | HBeAg positive patients treated with simultaneous administration of NA and Peg-IFN Receives: Drug: Peginterferon-α; Nucleoside analogs | |
| "add-on" strategy-HBeAg positive | HBeAg positive patients treated with NA followed by addition of Peg-IFN. Receives: Drug: Peginterferon-α; Nucleoside analogs | |
| "add-on" strategy-HBeAg negative | HBeAg negative patients treated with NA followed by addition of Peg-IFN. Receives: Drug: Peginterferon-α; Nucleoside analogs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional cure of chronic hepatit B
The level of hepatitis B surface antigen (HBsAg) is below 0.05IU/ml.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start6 Jan 2024
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196632
- Sponsor's protocol ID
- KYLL-2023(ZM)-726
- Status last verified
- Dec 2023
- First submitted
- 25 Dec 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu HH, Jiang XM, Cui C, Zhao J, Xu J, Wang SK, Hu LH, Yin YP, Wang X, Yu LJ, Xu C, Zhao ZH, Xing YQ, Liu Y, Wang K, Gao S. Development and Validation of a Predictive Model for HBsAg Seroclearance After Peg-IFN-Based Therapy: A Multicentre Study. Drug Des Devel Ther. 2025 Nov 7;19:9973-9982. doi: 10.2147/DDDT.S545700. eCollection 2025.
PubMed 41229921
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Logistic Regression Models to Predict Durable Functional Cure in Patients With Chronic Hepatitis B After Pegylated Interferon Alpha-2b Based Therapy
- ClinicalTrials.gov ID
- NCT06196632
- Acronym / sponsor ID
- KYLL-2023(ZM)-726
- Conditions
- Hepatitis B, Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 6 Jan 2024 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Jan 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.
Hepatitis B virus (HBV) infection is prevalent across the world. Functional cure is the optimal endpoint of antiviral therapy for chronic hepatitis B virus (HBV) infection. Currently available anti-HBV therapy includes nucleoside analogs (NAs) and peginterferon-α (Peg-IFNα). Combination of Peg-IFNα and NAs, each with different mechanisms of action, is an attractive approach for treating chronic HBV infection. In this study, we aim to establish logistic regression models to predict durable functional cure in patients with CHB treated by combination of Peg-IFNα and NAs, which might be useful for clinical physicians to make personalized treatment decisions. These models will be constructed using baseline routine clinical laboratory indicators with high diagnostic accuracy. These models might be widely applicable to almost all medical institutions and will effectively promote the application of Peg IFN α plus NAs therapy in clinical work. The findings in this study might greatly improve the functional cure rate of CHB and reducing the incidence rate and mortality of HBV related end-stage liver diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| "de novo" strategy-HBeAg positive | – | Drug: Peginterferon-α; Nucleoside analogsHBeAg positive patients treated with simultaneous administration of NA and Peg-IFN |
| "de novo" strategy-HBeAg negative | – | Drug: Peginterferon-α; Nucleoside analogsHBeAg positive patients treated with simultaneous administration of NA and Peg-IFN |
| "add-on" strategy-HBeAg positive | – | Drug: Peginterferon-α; Nucleoside analogsHBeAg positive patients treated with NA followed by addition of Peg-IFN. |
| "add-on" strategy-HBeAg negative | – | Drug: Peginterferon-α; Nucleoside analogsHBeAg negative patients treated with NA followed by addition of Peg-IFN. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The participants were retrospectively enrolled from more than 10 hospitals in China.
Key inclusion criteria (5 listed)
- 1. Sign an informed consent form;
- 2. HBsAg (+), and the course of the disease exceeds six months;
- 3. Age range from 16 to 70 years old;
- 4. Female participants of childbearing age who had a negative pregnancy test before the trial and were able to take effective contraceptive measures;
- 5. During the treatment period, within six months after the end of treatment, the patients agrees to use contraception
Key exclusion criteria (13 listed)
- 1. Patients with a known history of allergy to Peg-IFNα and NAs;
- 2. Co-infection with other virus such as HAV, HCV, HDV, HEV, HIV, etc;
- 3. Patients with liver cirrhosis or a Child Pugh score of 7 or above;
- 4. History or evidence of liver disease caused by other factors (such as autoimmune liver disease, alcoholic liver disease, non-alcoholic fatty liver disease, drug-induced hepatitis, hepatolenticular degeneration, etc.);
- 5. Pregnant or lactating women; Have a history of alcohol or drug abuse within the year prior to the trial enrollment screening;
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 |
|---|---|---|
| Peginterferon-α; Nucleoside analogsPatients with chronic hepatitis B were treated with the combination of peginterferon-α and nucleoside analogs | Drug | "add-on" strategy-HBeAg negative, "add-on" strategy-HBeAg positive, "de novo" strategy-HBeAg negative, "de novo" strategy-HBeAg positive |
Primary outcome
Functional cure of chronic hepatit B
Time frame: 48 weeks
The level of hepatitis B surface antigen (HBsAg) is below 0.05IU/ml.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 41229921Liu HH, Jiang XM, Cui C, Zhao J, Xu J, Wang SK, Hu LH, Yin YP, Wang X, Yu LJ, Xu C, Zhao ZH, Xing YQ, Liu Y, Wang K, Gao S. Development and Validation of a Predictive Model for HBsAg Seroclearance After Peg-IFN-Based Therapy: A Multicentre Study. Drug Des Devel Ther. 2025 Nov 7;19:9973-9982. doi: 10.2147/DDDT.S545700. eCollection 2025.
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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.
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 Qilu Hospital of Shandong 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 5 inclusion and 13 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 7 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuai Gao, MD;PhD (+86-18560088213, qilugaoshuai@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional cure of chronic hepatit B (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06196632, which also lists 1 linked publication.
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 7 Feb 2024.