Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa
NCT ID: NCT02344498
Last Updated: 2024-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
7350 participants
OBSERVATIONAL
2015-01-31
2026-12-31
Brief Summary
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Detailed Description
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The present study will investigate a simplified approach to hepatitis B treatment in resource-limited settings, inspired by the recent success of HIV treatment in such settings. The critical research question is how to identify patients with expected benefit of treatment in the absence of advanced laboratory support. A WHO expert panel recently suggested treatment criteria for use in settings without advanced laboratory facilities, but these criteria have not yet been tested out in real life. The present study will build on and develop the WHO approach to treatment of hepatitis B, aiming to develop a treatment protocol that can be feasible in other resource-limited countries. The potential public health benefit for poor people in low- and middle-income countries is substantial.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Urban
HBV patients in Addis Abeba. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.
Tenofovir disoproxil
Rural
HBV patients in Adama, Afar, Jigjiga and Jimma. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.
Tenofovir disoproxil
Interventions
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Tenofovir disoproxil
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Addis Ababa University
OTHER
The Research Council of Norway
OTHER
University of Agder
OTHER
South-Eastern Norway Regional Health Authority, Norway
UNKNOWN
St. Paul's Hospital Millennium Medical College, Ethiopia
OTHER
Haramaya University,Ethiopia
UNKNOWN
Oslo University Hospital
OTHER
Responsible Party
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Asgeir Johannessen
Researcher / project manager
Principal Investigators
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Asgeir Johannessen, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Nega Berhe, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Addis Abeba University
Locations
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St Paul Hospital Millennium Medical College
Addis Ababa, Addis Abeba, Ethiopia
Countries
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References
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Rossvoll L, Desalegn H, Gudissa FG, Birhanu D, Hussen A, Cheneke W, Jeylan A, Debela EA, Yusuf M, Sugule A, Berhanu N, Gudina EK, Orlien SM, Stockdale AJ, Berhe N, Johannessen A. Treatment of chronic hepatitis B in Ethiopia: 1-year results from a real-life, multicentre, prospective cohort study. Lancet Glob Health. 2025 Nov;13(11):e1914-e1923. doi: 10.1016/S2214-109X(25)00309-2.
Desalegn H, Orlien SMS, Aberra H, Mamo E, Grude S, Hommersand K, Berhe N, Gundersen SG, Johannessen A. Five-year results of a treatment program for chronic hepatitis B in Ethiopia. BMC Med. 2023 Sep 29;21(1):373. doi: 10.1186/s12916-023-03082-4.
Desalegn H, Aberra H, Berhe N, Medhin G, Mekasha B, Gundersen SG, Johannessen A. Predictors of mortality in patients under treatment for chronic hepatitis B in Ethiopia: a prospective cohort study. BMC Gastroenterol. 2019 May 15;19(1):74. doi: 10.1186/s12876-019-0993-1.
Aberra H, Desalegn H, Berhe N, Mekasha B, Medhin G, Gundersen SG, Johannessen A. The WHO guidelines for chronic hepatitis B fail to detect half of the patients in need of treatment in Ethiopia. J Hepatol. 2019 Jun;70(6):1065-1071. doi: 10.1016/j.jhep.2019.01.037. Epub 2019 Mar 28.
Desalegn H, Aberra H, Berhe N, Mekasha B, Stene-Johansen K, Krarup H, Pereira AP, Gundersen SG, Johannessen A. Treatment of chronic hepatitis B in sub-Saharan Africa: 1-year results of a pilot program in Ethiopia. BMC Med. 2018 Dec 17;16(1):234. doi: 10.1186/s12916-018-1229-x.
Aberra H, Gordien E, Desalegn H, Berhe N, Medhin G, Mekasha B, Gundersen SG, Gerber A, Stene-Johansen K, Overbo J, Johannessen A. Hepatitis delta virus infection in a large cohort of chronic hepatitis B patients in Ethiopia. Liver Int. 2018 Jun;38(6):1000-1009. doi: 10.1111/liv.13607. Epub 2017 Oct 20.
Aberra H, Desalegn H, Berhe N, Medhin G, Stene-Johansen K, Gundersen SG, Johannessen A. Early experiences from one of the first treatment programs for chronic hepatitis B in sub-Saharan Africa. BMC Infect Dis. 2017 Jun 19;17(1):438. doi: 10.1186/s12879-017-2549-8.
Desalegn H, Aberra H, Berhe N, Gundersen SG, Johannessen A. Are non-invasive fibrosis markers for chronic hepatitis B reliable in sub-Saharan Africa? Liver Int. 2017 Oct;37(10):1461-1467. doi: 10.1111/liv.13393. Epub 2017 Mar 23.
Other Identifiers
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2014/1146
Identifier Type: -
Identifier Source: org_study_id
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