An observational study in Hepatitis B, Chronic, sponsored by Qilu Hospital of Shandong University. Recruiting at 1 site in China. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by Qilu Hospital of Shandong University · Observational
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.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 390 across 407 observational studies indexed under Hepatitis B.
Browse Hepatitis B studies →Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The participants were retrospectively enrolled from more than 10 hospitals in China.
Exclusion Criteria:
HBeAg positive patients treated with simultaneous administration of NA and Peg-IFN
Drug: Peginterferon-α; Nucleoside analogs
HBeAg positive patients treated with simultaneous administration of NA and Peg-IFN
Drug: Peginterferon-α; Nucleoside analogs
HBeAg positive patients treated with NA followed by addition of Peg-IFN.
Drug: Peginterferon-α; Nucleoside analogs
HBeAg negative patients treated with NA followed by addition of Peg-IFN.
Drug: Peginterferon-α; Nucleoside analogs
Patients with chronic hepatitis B were treated with the combination of peginterferon-α and nucleoside analogs
Functional cure of chronic hepatit B
The level of hepatitis B surface antigen (HBsAg) is below 0.05IU/ml.
Time frame: 48 weeks
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Qilu Hospital of Shandong University