Development and Validation of Models to Predict Functional Cure in Patients With CHB After Peg-IFN Based Therapy

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Dec 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat chronic hepatitis B (CHB) by using a combination of two treatments: peginterferon-α (Peg-IFNα) and nucleoside analogs (NAs). The goal is to find out if these treatments can help patients achieve a "functional cure," meaning that the virus is no longer active in the body and doesn’t cause liver damage. Researchers are creating models that can help doctors predict which patients are most likely to respond well to this combination therapy. This could lead to more personalized treatment plans and potentially better outcomes for patients with chronic hepatitis B.

To participate in this trial, you need to be between 16 and 70 years old, have been diagnosed with hepatitis B for at least six months, and be willing to use effective contraception if you are a woman of childbearing age. Certain individuals, such as those with severe liver disease, other viral infections, or specific medical conditions, are not eligible to participate. If you join the trial, you can expect close monitoring and support from the research team throughout the treatment process, which may help improve your chances of achieving a functional cure and reduce the risk of serious liver problems in the future.

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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.