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NCT05965388Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 28 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
5000 (estimated)
First submitted
28 Jun 2023
Start date
1 Dec 2023
Primary completion date
1 Feb 2029
Lead sponsor
Wen-hong Zhang
Diseases
Hepatitis B
NCT number
NCT05965388

What you commit to

  • Study type: Observational
  • Planned participants: 5000
  • From 1 Dec 2023 to the primary completion date, 1 Feb 2029
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with malignancies other than hepatocellular carcinoma.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaUnknown status
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaUnknown status
Shandong Provincial Hospital of Shandong University
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JinanChinaUnknown status
The First People's Hospital of Yunnan
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KunmingChinaUnknown status
Jiangsu Province Hospital
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NanjingChinaUnknown status
Huashan Hospital
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ShanghaiChinaUnknown status
The Third People's Hospital of Taiyuan
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TaiyuanChinaUnknown status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
First Affiliated Hospital Xi'an Jiaotong University
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Xi’anChinaUnknown status
the Affiliated Hosptial of Xuzhou Medical University
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XuzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.