Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa
1 other identifier
observational
7,350
1 country
1
Brief Summary
Viral hepatitis kills nearly one million people each year, even though effective treatment exists. The aim of this study is to establish a treatment protocol for hepatitis B, which is simple and cheap enough to be implemented in resource-limited settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 16, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
November 15, 2024
November 1, 2024
11.9 years
January 16, 2015
November 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death, HCC or decompensated cirrhosis
Patients will be reviewed every 3-6 months with liver function tests and/or ultrasound to detect the proportion of participants who develop liver decompensation or hepatocellular carcinoma.
3 years
Secondary Outcomes (3)
Viral suppression and genotypic resistance
3 years
Regression of liver inflammation/fibrosis
3 years
Adherence to therapy
3 years
Other Outcomes (1)
Sensitivity and specificity of HBsAg rapid tests
1 year
Study Arms (2)
Urban
HBV patients in Addis Abeba. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.
Rural
HBV patients in Adama, Afar, Jigjiga and Jimma. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.
Interventions
Eligibility Criteria
All adults with a positive HBsAg rapid test are eligible for inclusion.
You may qualify if:
- Consenting adults (≥18 years) residing in Ethiopia who are HBsAg positive
You may not qualify if:
- Children \<18 years, other terminal disease (cancer etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- Addis Ababa Universitycollaborator
- The Research Council of Norwaycollaborator
- University of Agdercollaborator
- South-Eastern Norway Regional Health Authority, Norwaycollaborator
- St. Paul's Hospital Millennium Medical College, Ethiopiacollaborator
- Haramaya University,Ethiopiacollaborator
Study Sites (1)
St Paul Hospital Millennium Medical College
Addis Ababa, Addis Abeba, Ethiopia
Related Publications (8)
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.
PMID: 41109262DERIVEDDesalegn 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.
PMID: 37775742DERIVEDDesalegn 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.
PMID: 31092203DERIVEDAberra 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.
PMID: 30929749DERIVEDDesalegn 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.
PMID: 30554571DERIVEDAberra 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.
PMID: 28980394DERIVEDAberra 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.
PMID: 28629395DERIVEDDesalegn 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.
PMID: 28222249DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asgeir Johannessen, MD PhD
Oslo University Hospital
- PRINCIPAL INVESTIGATOR
Nega Berhe, MD PhD
Addis Abeba University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher / project manager
Study Record Dates
First Submitted
January 16, 2015
First Posted
January 26, 2015
Study Start
January 1, 2015
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
November 15, 2024
Record last verified: 2024-11