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NCT Number: NCT05965388

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

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nucleoside analogues or interferon

Drug

ETV、TDF、TAF、TAF、IFN-a-2b

Primary outcomes

  1. Number of Participants with Diagnosis of hepatocellular carcinoma during the observation period

    Time frame: 5 years

    Number of Participants with Diagnosis of hepatocellular carcinoma

Secondary outcomes

  1. Number of Participants with Diagnosis of participants with decompensation cirrhosis during the observation period

    Time frame: 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

  2. Number of Participants with Diagnosis of participants with liver transplantation during the observation period

    Time frame: 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

  3. Number of Participants with Diagnosis of participants with fibrosis regression and progression during the observation period

    Time frame: 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

  4. Number of Participants with Diagnosis of participants with serological response during the observation period

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Wenhong Zhang, MD

CONTACT

[email protected]

13801844344

Sponsors and collaborators

Lead sponsor

Wen-hong Zhang

Other

Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University
  • First Affiliated Hospital of Fujian Medical University
  • Shandong Provincial Hospital
  • 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
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Jul 28, 2023
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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