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

Hepatitis B, Chronic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06196632
• Other study ID #: KYLL-2023(ZM)-726
• Status: Recruiting
• Start date: January 6, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Qilu Hospital of Shandong University
• Contact: Shuai Gao, MD;PhD
• Phone: +86-18560088213
• Email: qilugaoshuai[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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-IFNa 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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• Peginterferon-a; Nucleoside analogs
Patients with chronic hepatitis B were treated with the combination of peginterferon-a and nucleoside analogs

Locations

Country	Name	City	State
China	Qilu hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional cure of chronic hepatit B	The level of hepatitis B surface antigen (HBsAg) is below 0.05IU/ml.	48 weeks