Observational Study of Persons With Hepatitis B Virus Infection in North America

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Updated on 8 November 2020

Summary

Background
  • Chronic hepatitis B virus infection is a leading cause of morbidity and mortality from end stage liver disease and liver cancer. Although significant progress has been made recently in hepatitis B therapy, current knowledge about how to manage the infection is limited because most treatment trials involve 1 to 2 years of therapy at most, even though most patients require treatment of much longer duration for optimal long-term outcome. To improve current knowledge on the disease and long-term disease progression, the Hepatitis B Research Network is collecting health and disease information from individuals who have been diagnosed with hepatitis B.
    Objectives
  • To study individuals with hepatitis B and identify factors that affect the way the disease progresses.
    Eligibility
  • Individuals at least 18 years of age who have been diagnosed with hepatitis B.
    Design
  • Participants will be screened with a physical examination and medical history. Health information will be collected through questionnaires and surveys on health behaviors, and family history of liver disease. Participants will also provide blood samples, and those who have had a liver biopsy within the past 2 years or have one during the course of the study will provide biopsy material for further study.
  • Information will be collected during a series of study visits. Each visit will take approximately 1 hour. During the first year, participants will have study visits 12 weeks, 24 weeks, and 48 weeks after entering the study. In subsequent years, participants will have a study visit approximately every 24 weeks (6 months) until the end of the study.
  • Additional visits will be required of women who are pregnant when enrolled in the study or become pregnant during the course of the study.
  • Participants whose hepatitis B status changes during the course of the study (for example, a flare of disease activity) may be asked to return for more frequent visits.

Description

Chronic hepatitis B virus infection is a leading cause of morbidity and mortality due to end stage liver disease and liver cancer. Although significant progress has been made in hepatitis B therapy, current knowledge about how to manage the infection is limited. To improve current knowledge on the disease and long-term disease progression, the Hepatitis B Research Network is collecting health and disease information from individuals who have been diagnosed with hepatitis B.

The objectives of this study are to study individuals with acute and chronic hepatitis B to identify factors that affect disease progression. Individuals at least 18 years of age who have been diagnosed with hepatitis B will be eligible to participate. Participants will be screened with a physical examination and medical history. Health information will be collected through questionnaires and surveys on health behaviors and family history of liver disease. Participants will also provide blood samples, and those who have had a liver biopsy within the past 2 years or have one during the course of the study will be asked to provide biopsy material for further study. Information will be collected during a series of study visits, and additional visits will be required of women who are pregnant when enrolled in the study or become pregnant during the course of the study. Participants whose hepatitis B status changes during the course of the study (for example, a flare of disease activity) may be asked to return for more frequent visits and may be eligible for treatment trials within the network.

Details
Condition Chronic Hepatitis B e Antigen Positive, Chronic Hepatitis B e Antigen Negative
Clinical Study IdentifierNCT01306071
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent
At least 18 years of age
HBsAg-positive and either
Pregnant
Anti-HDV positive
Diagnosed with acute HBV infection or experiencing a hepatitis flare
Immune tolerant or immune active phenotype
Potentially eligible for the Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B ancillary study

Exclusion Criteria

History of hepatic decompensation
Hepatocellular carcinoma (HCC)
History of solid organ transplantation or bone marrow transplantation
Current hepatitis B antiviral treatment (except pregnant women and patients who are anti-HDV positive)
Chronic immunosuppression therapy
Known HIV co-infection (patients with HDV or HCV co-infection are not excluded)
Medical or social condition which, in the opinion of the investigator, would make the patient unsuitable for the study or interfere with or prevent follow-up per protocol
Unable or unwilling to return for follow-up visits
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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