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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Qilu hospital of Shandong University
RECRUITING
Jinan
Contact Information
Primary
Shuai Gao, MD;PhD
qilugaoshuai@sdu.edu.cn
+86-18560088213
Time Frame
Start Date: 2024-01-06
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 1000
Treatments
de novo strategy-HBeAg positive
HBeAg positive patients treated with simultaneous administration of NA and Peg-IFN
de novo strategy-HBeAg negative
HBeAg positive patients treated with simultaneous administration of NA and Peg-IFN
add-on strategy-HBeAg positive
HBeAg positive patients treated with NA followed by addition of Peg-IFN.
add-on strategy-HBeAg negative
HBeAg negative patients treated with NA followed by addition of Peg-IFN.
Related Therapeutic Areas
Sponsors
Leads: Qilu Hospital of Shandong University

This content was sourced from clinicaltrials.gov