Observational Study of Persons With Hepatitis B Virus Infection in North America
|First Received Date ICMJE||February 26, 2011|
|Last Updated Date||May 1, 2013|
|Start Date ICMJE||February 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01306071 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Observational Study of Persons With Hepatitis B Virus Infection in North America|
|Official Title ICMJE||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.
- To describe participants with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression
Type of Study:
Patients with HBV infection will be identified by sites participating in the NIH-funded Hepatitis B Research Network (HBRN). Consenting patients who meet entry criteria will undergo a baseline evaluation. Those who are eligible for one of the treatment studies being conducted by the network will be approached about participating. If they are not eligible, unwilling to participate or have completed their participation in a treatment study, they will be followed longitudinally to observe clinical outcomes and changes in their virologic and immunologic status.
It is estimated that approximately 2,500 participants with HBV infection will be enrolled over a period of approximately 24 months. They will be followed indefinitely until the conclusion of the study, which is estimated presently to be up to 72 months.
Briefly, the standard visit schedule for participants will be at baseline, weeks 12, 24 and 48 in their first year of enrollment and every 24 weeks in subsequent years.
Variable follow up visits may be required if certain events are encountered. For example, for participants experiencing an ALT flare, as defined in section 3.2.1 and Appendix A, follow up will occur every 2-4 weeks until resolved and for HBeAg or HBsAg loss, participants will be asked to return in 12 and 24 weeks, and then resume follow-up of every 24 weeks.
The following events will be noted:
For women who are, or become, pregnant while enrolled in the cohort study, one visit will occur early in pregnancy (1st or 2nd trimester) and one later in pregnancy (at or after 28 weeks gestation). Such visits may coincide with a regularly scheduled visit or may be an additional visit. Following delivery, extra data will be collected at 12, 24, and 72 weeks post delivery (see Appendix E), either at a regularly scheduled visit or at a special visit.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||2500|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01306071|
|Other Study ID Numbers ICMJE||110108, 11-DK-0108|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP