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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier:
NCT01306071
First received: February 26, 2011
Last updated: November 11, 2014
Last verified: July 2014

February 26, 2011
November 11, 2014
February 2011
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To describe participants with hepatitis
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Complete list of historical versions of study NCT01306071 on ClinicalTrials.gov Archive Site
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Observational Study of Persons With Hepatitis B Virus Infection in North America
Observational Study of Persons With Hepatitis B Virus Infection in North America (Cohort Study)

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.

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.

Observational
Time Perspective: Prospective
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  • Chronic Hepatitis B e Antigen Positive
  • Chronic Hepatitis B e Antigen Negative
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2500
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  • 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
  • Chronic immunosuppression therapy
  • Current hepatitis B antiviral treatment (except pregnant women and patients who are anti-HDV positive)
  • 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
Both
18 Years and older
No
Contact: Nancy Fryzek (301) 435-6122 nancy.fryzek@nih.gov
Contact: Marc G Ghany, M.D. (301) 402-5115 mg228m@nih.gov
United States
 
NCT01306071
110108, 11-DK-0108
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National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Marc G Ghany, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health Clinical Center (CC)
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP