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:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01306071
First received: February 26, 2011
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.

Condition
Chronic Hepatitis B e Antigen Positive
Chronic Hepatitis B e Antigen Negative

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Observational Study of Persons With Hepatitis B Virus Infection in North America (Cohort Study)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To describe participants with hepatitis

Estimated Enrollment: 2500
Study Start Date: February 2011
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306071

Contacts
Contact: Nancy Fryzek (301) 435-6122 nancy.fryzek@nih.gov
Contact: Marc G Ghany, M.D. (301) 402-5115 mg228m@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Marc G Ghany, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01306071     History of Changes
Other Study ID Numbers: 110108, 11-DK-0108
Study First Received: February 26, 2011
Last Updated: July 29, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cirrhosis
Natural History
Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Hepatitis, Viral, Human
Virus Diseases
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on October 23, 2014