Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT06746701

Reclutando

Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA.

Observacional

Fase no especificada

The Third Affiliated Hospital of Sun Yat-sen University

Patrocinador: Xiangya Hospital of Central South University

Última actualización: 24 de diciembre de 2024
Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.

This is a retrospective prospective, open-label, multicenter clinical study aiming to recruit 400 individuals with a family history of liver cancer to explore the clinical cure rate and the effectiveness, feasibility, and safety of PEGylated interferon α-2b combined with nucleos(t)ide analogues in treating chronic HBV carriers with a family history of liver cancer for reducing the risk of liver cancer occurrence. Patients will enrolled into Group A (Peg-IFNα-2b combined with NA treatment group) or Group B (NA monotherapy group) based on their medication choices. Each group is expected to enroll 200 patients, with all patients followed up to 240 weeks. The dosage, frequency, and duration of treatment with Peg-IFN α-2b and NA will be prescribed by the researchers according to clinical practice and standard treatment protocols.

Categoría de tratamiento

Otros medicamentos

Erforderliche Mutationen

Ninguna

Ensayo iniciado

25 de mayo de 2023

Última actualización por el patrocinador

24 de diciembre de 2024

Finalización estimada

25 de mayo de 2027

Contacto del estudio

Nombre:LeDu Zhou, Ph.D

Correo electrónico:zhould@scu.cn

Teléfono:17373120367

Nombre:Lei Fu, Ph.D

Correo electrónico:fulei92@126.com

Teléfono:0731-84327221

Elegibilidad

Criterios de inclusión

* Age18-65 years (inclusive of 18 and 65), no restriction on gender;

* HBsAg positive history for at least 6 months;

* Family history of liver cancer [including first-degree and second-degree relatives; first-degree relatives are parents, children, and siblings (same parents), while second-degree relatives are uncles, aunts, grandparents, and great-grandparents; a family history of liver cancer means that one or more first-degree or second-degree relatives have had liver cancer];

* Planning to or already receiving treatment with Peginterferon alpha-2b in combination with nucleoside (acid) analogs, or receiving nucleoside (acid) analogs treatment alone;

* Negative urine or serum pregnancy test within 24 hours before the first dose (for women of childbearing age);

* Willing to receive treatment and sign an informed consent form.

Criterios de exclusión

* Allergy to interferon;

* History of using telbivudine for antiviral treatment;

* ALT(Alanine Aminotransferase) greater than 10 times the upper limit of normal, total bilirubin greater than 2 times the upper limit of normal;

* Decompensated liver cirrhosis;

* Neutrophil count < 1.5 x 10^9/L or platelet count < 80 x 10^9/L;

* Presence of severe lesions in vital organs such as the cardiovascular, pulmonary, renal, brain, and fundus;

* Those with autoimmune diseases, psychiatric disorders, poorly controlled diabetes, or thyroid dysfunction (hyperthyroidism or hypothyroidism);

* Confirmed or suspected liver cancer or other malignant tumors;

* Post-organ transplant or preparing for organ transplantation;

* Currently using immunosuppressants;

* Pregnant or planning to become pregnant within 2 years;

* Alcohol or drug addicts;

* HIV co-infection;

* Other conditions deemed unsuitable for interferon use by the attending physician.

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Detalles del diseño

AsignaciónN/A

Modelo de intervenciónN/A

EnmascaramientoN/A

Número a inscribir400

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: N/A

Descripción:

Intervenciones:

Peg-IFNα-2b combined with NA
Nucleotide Analogues

Medidas de resultado

Medidas de resultado primarias

Clinical cure ratethrough study completion, an average of 24 weeks.

The definition of a cure is: maintaining HBsAg(Hepatitis B surface antigen) negativity (with or without the appearance of anti-HBs), undetectable HBV DNA, normal liver biochemical indices, and improvement in liver tissue lesions after discontinuation of treatment.

Liver cancer incidence ratethrough study completion, an average of 24 weeks.

Medidas de resultado secundarias

The decrease in HBsAg compared to baseline.through study completion, an average of 24 weeks.

HBsAg seroconversion ratethrough study completion, an average of 24 weeks.

Changes of biomarkers after disease progression-related markers such as HBV DNA quantification compared to baseline.through study completion, an average of 24 weeks.

Incidence of abnormal and clinically relevant changes in vital signsthrough study completion, an average of 24 weeks.

Incidence of treatment-emergent adverse event (AE)through study completion, an average of 24 weeks.

Incidence of abnormal and clinically relevant changes in laboratory assessmentsthrough study completion, an average of 24 weeks.

Incidence of severe acute allergic reactions occurring during treatment.through study completion, an average of 24 weeks.

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Sitios del ensayo

Este estudio tiene 4 sitios de ensayo

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, CN

Nombre:LeDu Zhou, Ph.D

Reclutando

Guangzhou, Guangdong, CN

The Third Affiliated Hospital of Sun Yat-sen University

Reclutando

Chenzhou, Hunan, CN

Chenzhou Second People's Hospital

Reclutando

Hengyang, Hunan, CN

First Affiliated Hospital of Nanhua University

Reclutando

Hengyang, Hunan, CN

Hengyang Third People's Hospital

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