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

NCT05965388 | Not Yet Recruiting FDA Drug

• 1 other identifier: COMPASS by REASON
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 10

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.

Conditions

HBV; HCC

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Diagnosis of hepatocellular carcinoma during the observation period

  Number of Participants with Diagnosis of hepatocellular carcinoma

  5 years

Secondary Outcomes (4)

• 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 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 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 serological response during the observation period

  Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240

Study Arms (1)

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

Interventions

nucleoside analogues or interferon DRUG

ETV、TDF、TAF、TAF、IFN-a-2b

Chronic hepatitis B patients treated with nucleoside analogues or interferon

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patients with malignancies other than hepatocellular carcinoma.

Sponsors & Collaborators

• Wen-hong Zhang: lead
• Shandong Provincial Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• First Affiliated Hospital of Fujian Medical University: collaborator
• The Third People's Hospital of Taiyuan: collaborator
• The First People's Hospital of Yunnan: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator

Study Sites (10)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350004, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210000, China

Location

the Affiliated Hosptial of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

Shandong Provincial Hospital of Shandong University

Jinan, Shandong, China

Location

The Third People's Hospital of Taiyuan

Taiyuan, Shanxi, China

Location

First Affiliated Hospital Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

Location

The First People's Hospital Of YunNan

Kunming, Yunnan, 650100, China

Location

Huashan Hospital

Shanghai, 200040, China

Location

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Collect the serum samples of CHB patients receiving antiviral therapy during long-term follow-up, and detect the concentration of HBV pgRNA in the samples

MeSH Terms

Interventions

Interferons

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Wenhong Zhang, MD

CONTACT

13801844344; zhangwenhong@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Division ofInfectious Diseases Affiliation: Huashan Hospital

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 28, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

CN (10)