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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03149627 |
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Date of registration:
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08/05/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Chronic Hepatitis B Virus Clinical Epidemiology in a Representative Sample of Zambian Adults
HEP-ZED |
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Scientific title:
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Chronic Hepatitis B Virus Clinical Epidemiology in a Representative Sample of Zambian Adults |
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Date of first enrolment:
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June 7, 2017 |
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Target sample size:
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5003 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03149627 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Zambia
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Contacts
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Name:
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Michael J Vinikoor, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alabama at Birmingham |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Part 1: 18 years or older, current residence in selected household
- Part 2: Participant in part 1 of the study, HBsAg-positive by rapid point-of-care test
Exclusion Criteria:
- Part 1: Unable to provide informed consent
- Part 2: Unwilling to travel to a hospital in their province
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Alcoholic Hepatitis
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HBV
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Liver Fibroses
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Intervention(s)
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Other: Estimates - prevalence of lifetime/chronic HBV infection
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Primary Outcome(s)
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Prevalence and correlates of lifetime HBV infection
[Time Frame: baseline]
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Secondary Outcome(s)
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HIV prevalence in HBV-patients
[Time Frame: within 1 month of part 1]
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Unhealthy alcohol use in HBV-positive patients
[Time Frame: within 1 month of part 1]
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Hepatosplenic schistosomiasis co-infection with liver fibrosis markers among patients with chronic HBV infection
[Time Frame: within 1 month of part 1]
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Clinical phenotypes of patients with chronic HBV infection
[Time Frame: within 1 month of part 1]
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Proportion of Zambian adults who require antiviral therapy for chronic HBV infection
[Time Frame: within 1 month of part 1]
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Frequency of primary drug resistance mutations.
[Time Frame: within 1 month of part 1]
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The proportion of patients with chronic HBV infection who have significant liver fibrosis or cirrhosis.
[Time Frame: within 1 month of part 1]
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Secondary ID(s)
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X160524001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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