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Search / Trial NCT04896255

Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B

Launched by HUASHAN HOSPITAL · May 20, 2021

Trial Information

Current as of May 02, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the long-term effects of different anti-viral treatments for patients with chronic Hepatitis B, a liver infection caused by the Hepatitis B virus. The researchers want to compare how well two types of treatments—one that includes a medication called peginterferon alpha and another that uses nucleos(t)ide medications—work over time. They will monitor participants for five years to see how these treatments affect health outcomes, such as the risk of liver cancer and severe liver problems.

To join the study, participants need to be at least 18 years old and have a positive Hepatitis B test for over six months. People over 70 should be generally healthy. They must be planning to start or already be on one of the anti-viral treatments, like Entecavir or Tenofovir. Participants will need to agree to take part in the study and sign a consent form. This research is important as it will help doctors better understand which treatments are most effective for managing chronic Hepatitis B over the long term.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Male and female patients with age ≥18; subjects who are over 70 years of age must be in generally stable health conditions.
  • There should be evidences that HBsAg has been positive for more than 6 months or HBV-related histological changes.
  • Planned to receive or already receiving anti-viral treatment with nucleos(t)ide including Entecavir, Tenofovir, and Tenofoviralafenamide. Or planned to receive peginterferon alpha 2b, either treated or treatment-naive.
  • Agree to participate in the study and sign the patient informed consent form.
  • Exclusion Criteria:
  • Currently treatment-related participating clinical trials.

About Huashan Hospital

Huashan Hospital, affiliated with Fudan University in Shanghai, is a leading medical institution renowned for its commitment to innovative research and high-quality patient care. As a prominent clinical trial sponsor, Huashan Hospital leverages its extensive expertise in various medical disciplines to advance the development of new therapies and treatment modalities. The hospital's state-of-the-art facilities and multidisciplinary teams facilitate rigorous clinical investigations, ensuring adherence to ethical standards and regulatory compliance. With a focus on improving patient outcomes, Huashan Hospital actively collaborates with academic and industry partners to drive forward-thinking research initiatives that address critical healthcare challenges.

Locations

Shanghai, , China

Patients applied

0 patients applied

Trial Officials

Wenhong Zhang, MD

Principal Investigator

Huashan Hospital

Jiming Zhang, MD

Principal Investigator

Huashan Hospital

Feng Sun, MD

Study Chair

Huashan Hospital

Qiran Zhang, MD

Study Director

Huashan Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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