Predicting functional cure in chronic hepatitis B patients after treatment

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

This study is testing a new way to predict which patients with chronic hepatitis B can achieve a lasting recovery after receiving a specific combination of treatments.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 16 Years to 70 Years
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06196632 on ClinicalTrials.gov

What this trial studies

This study aims to develop and validate logistic regression models that can predict a durable functional cure in patients with chronic hepatitis B (CHB) who are treated with a combination of peginterferon-α and nucleoside analogs. By analyzing baseline clinical laboratory indicators, the study seeks to provide personalized treatment recommendations for physicians. The models are designed to be applicable across various medical institutions, potentially enhancing the effectiveness of current antiviral therapies for CHB. The ultimate goal is to improve patient outcomes through better-informed treatment decisions.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 16 to 70 with chronic hepatitis B who have been infected for more than six months.

Not a fit: Patients with liver cirrhosis, co-infections with other viruses, or a history of allergy to the study medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and personalized treatment strategies for patients with chronic hepatitis B.

How similar studies have performed: While the approach of using predictive models in hepatitis B treatment is promising, the specific methodology of this study has not been widely tested in previous research.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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;
* 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.

Where this trial is running

Jinan, Shandong

• Qilu hospital of Shandong University — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Shuai Gao, MD;PhD

Conditions Hepatitis B, Chronic