Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy

HCC Clinical Trial

Official title:

Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05965388
• Other study ID #: COMPASS by REASON
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: February 1, 2029

Study information

• Verified date: July 2023
• Source: Huashan Hospital
• Contact: Wenhong Zhang, MD
• Phone: 13801844344
• Email: zhangwenhong[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this prospective, exploratory, non-intervention, multi-center, real-world study is to investigate the predictive value of HBV pgRNA in the occurrence of long-term outcomes under antiviral therapy in patients with chronic hepatitis B. Participants will take the necessary clinical examination and blood draw during the patient's treatment and follow-up, and all the treatment is determined by clinicians.

Description:

This study is a prospective, exploratory, multi-center, real-world study, with Huashan Hospital as the leading unit. The study includes patients with chronic hepatitis B who have been determined by clinicians to start, or have already taken the first-line treatment { including pegylated interferon [IFN] monotherapy, a potent nucleos(t)ide analogue [NA] monotherapy, two different potent NAs combination therapy, or NA plus IFN combination therapy. The study only collects clinical data and serum samples, without imposing any additional intervention measures or affecting any relevant clinical decisions. The clinical data is collected from the patient's clinical follow-up examination data, without additional visits and auxiliary examinations. Sample collection During the necessary clinical examination and blood draw during the patient's treatment and follow-up, one additional serum separation tube (3ml) was drawn, without additional invasive examination for the patient. The study will follow up with patients for 5 years to explore the relationship between the serum HBV pgRNA level and the endpoint event at different time points.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: February 1, 2029
• Est. primary completion date: February 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• CHB defined as positive hepatitis B surface antigen at least 6 months, or HBV-related histological changes within 1 year if HBsAg positive less than 6 months;
• Age between 18-80 years, gender is not limited;
• Patients with chronic hepatitis B who have been determined by clinicians to start, or have already taken the first-line treatment {including pegylated interferon [IFN] monotherapy, a potent nucleos(t)ide analogue [NA] monotherapy, two different potent NAs combination therapy, or NA plus IFN combination therapy;
• Patient who reads and signs informed consent.

Exclusion Criteria:

• Patients with malignancies other than hepatocellular carcinoma.

Related Conditions & MeSH terms

• HBV
• HCC
• Hepatitis B

Intervention

Drug:
• nucleoside analogues or interferon
ETV?TDF?TAF?TAF?IFN-a-2b

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Shandong Provincial Hospital of Shandong University	Jinan	Shandong
China	The First People's Hospital Of YunNan	Kunming	Yunnan
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Huashan Hospital	Shanghai
China	The Third People's Hospital of Taiyuan	Taiyuan	Shanxi
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	First Affiliated Hospital Xi'an Jiaotong University	Xi'an	Shanxi
China	the Affiliated Hosptial of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (10)

Lead Sponsor

Collaborator

Wen-hong Zhang

First Affiliated Hospital of Fujian Medical University, First Affiliated Hospital Xi'an Jiaotong University, Shandong Provincial Hospital Affiliated to Shandong First Medical University, The Affiliated Hospital of Xuzhou Medical University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital with Nanjing Medical University, The First People's Hospital of Yunnan, The Third People's Hospital of Taiyuan, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Diagnosis of hepatocellular carcinoma during the observation period	Number of Participants with Diagnosis of hepatocellular carcinoma	5 years
Secondary	Number of Participants with Diagnosis of participants with decompensation cirrhosis during the observation period	Number of Participants with Diagnosis of participants with decompensation cirrhosis	Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240
Secondary	Number of Participants with Diagnosis of participants with liver transplantation during the observation period	Number of Participants with Diagnosis of participants with liver transplantation	Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240
Secondary	Number of Participants with Diagnosis of participants with fibrosis regression and progression during the observation period	Number of Participants with Diagnosis of participants with fibrosis regression and progression	Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240
Secondary	Number of Participants with Diagnosis of participants with serological response during the observation period	Hepatitis B s Antigen (HBsAg) Loss, seroconversion to HBsAg, Hepatitis B s Antigen (HBeAg) Loss (only patients who are HBeAg positive at baseline), and seroconversion to HBeAg	Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240