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

Sponsor

Wen-hong Zhang (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05965388

Collaborator

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

5,000

Enrollment

Locations

62.1

Anticipated Duration (Months)

500

Patients Per Site

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HBV HCC	Drug: nucleoside analogues or interferon

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2029

Anticipated Study Completion Date :

Feb 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Chronic hepatitis B patients treated with nucleoside analogues or interferon Chronic hepatitis B patients treated with nucleoside analogues or interferon	Drug: nucleoside analogues or interferon ETV、TDF、TAF、TAF、IFN-a-2b

Arm

Intervention/Treatment

Chronic hepatitis B patients treated with nucleoside analogues or interferon

Drug: nucleoside analogues or interferon

ETV、TDF、TAF、TAF、IFN-a-2b

Outcome Measures

Primary Outcome Measures

Number of Participants with Diagnosis of hepatocellular carcinoma during the observation period [5 years]
Number of Participants with Diagnosis of hepatocellular carcinoma

Secondary Outcome Measures

Number of Participants with Diagnosis of participants with decompensation cirrhosis during the observation period [Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240]
Number of Participants with Diagnosis of participants with decompensation cirrhosis
Number of Participants with Diagnosis of participants with liver transplantation during the observation period [Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240]
Number of Participants with Diagnosis of participants with liver transplantation
Number of Participants with Diagnosis of participants with fibrosis regression and progression during the observation period [Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240]
Number of Participants with Diagnosis of participants with fibrosis regression and progression
Number of Participants with Diagnosis of participants with serological response during the observation period [Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui	China	230022
2	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	China	350004
3	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430000
4	Jiangsu Province Hospital	Nanjing	Jiangsu	China	210000
5	the Affiliated Hosptial of Xuzhou Medical University	Xuzhou	Jiangsu	China	221000
6	Shandong Provincial Hospital of Shandong University	Jinan	Shandong	China
7	The Third People's Hospital of Taiyuan	Taiyuan	Shanxi	China
8	First Affiliated Hospital Xi'an Jiaotong University	Xi'an	Shanxi	China	710061
9	The First People's Hospital Of YunNan	Kunming	Yunnan	China	650100
10	Huashan Hospital	Shanghai		China	200040

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Wen-hong Zhang, Director of Division ofInfectious Diseases Affiliation: Huashan Hospital, Huashan Hospital

ClinicalTrials.gov Identifier:

NCT05965388

Other Study ID Numbers:

COMPASS by REASON

First Posted:

Jul 28, 2023

Last Update Posted:

Jul 28, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Hepatitis B

Interferons

Study Results

No Results Posted as of Jul 28, 2023