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NCT Number: NCT03181113

Long-term Benefit in Chronic Hepatitis B Patients After Standard Peginterferon Alfa Therapy

In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN study and received at least 39 doses of peginterferon alfa will be enrolled. HBsAg/anti-HBs level, HBeAg/anti-HBe level, Serum HBV DNA load and alanine transaminase level will be test every year from the second year to the fifth year after the ending of peginterferon alfa treatment, and long-term benefit of interferon treatment will be evaluated.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

302 Military Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Understand and sign the informed consent form.
  • Participated in NCT01760122 study (TB1211IFN) and has received at least 39 doses of peginterferon.

Exclusion criteria

  • Conditions which in the opinion of the investigator should be precluded from the study(e.g., poor compliance).

Treatment and study plan

Peginterferon alfa-2b

Drug

pre-received standard peginterferon alfa-2b therapy

Other names: pegberon

Peginterferon alfa-2a

Drug

pre-received standard peginterferon alfa-2a therapy

Other names: pegasys

Primary outcomes

  1. rate of HBeAg seroconversion

    Time frame: from the second year to the fifth year

Secondary outcomes

  1. decent degree of HBeAg

    Time frame: from the second year to the fifth year

  2. decent degree of HBV DNA

    Time frame: from the second year to the fifth year

  3. rate of alanine aminotransferase normalization

    Time frame: from the second year to the fifth year

  4. rate of HBeAg loss

    Time frame: from the second year to the fifth year

  5. rate of HBV DNA undetectable

    Time frame: from the second year to the fifth year

  6. rate of HBeAg seroconversion

    Time frame: from the second year to the fifth year

Sponsors and collaborators

Lead sponsor

Xiamen Amoytop Biotech Co., Ltd.

Industry

Collaborators

  • Peking University First Hospital

Registry information

Official study title

A Multi-center, Prospective Study to Acess Long-term Benefit in HBeAg Positive Chronic Hepatitis B Patients Who Previously Received Standard Peginterferon Alfa Therapy

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 8, 2017
Registry last updated
Apr 13, 2021

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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