Observational Study of Persons With Hepatitis B Virus Infection in North America
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|ClinicalTrials.gov Identifier: NCT01306071|
Recruitment Status : Recruiting
First Posted : March 1, 2011
Last Update Posted : March 2, 2018
|First Submitted Date||February 26, 2011|
|First Posted Date||March 1, 2011|
|Last Update Posted Date||March 2, 2018|
|Start Date||February 26, 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||To describe participants with hepatitis|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01306071 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Observational Study of Persons With Hepatitis B Virus Infection in North America|
|Official Title||Observational Study of Persons With Hepatitis B Virus Infection in North America (Cohort Study)|
- 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.
- To study individuals with hepatitis B and identify factors that affect the way the disease progresses.
- Individuals at least 18 years of age who have been diagnosed with hepatitis B.
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.
|Study Design||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Ages||18 Years to 100 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||110108
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )|
|Study Sponsor||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 21, 2018|