Hepatitis BNCT02344498
Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa
An observational study of Hepatitis B, run by Oslo University Hospital at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Tenofovir disoproxil
- How many people
- 7,350 participants
- Where
- 1 siteEthiopia
- Study dates
- Jan 2015to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults with a positive HBsAg rapid test are eligible for inclusion.
Who may be able to join
- Consenting adults (≥18 years) residing in Ethiopia who are HBsAg positive
Who cannot join
- Children <18 years, other terminal disease (cancer etc.)
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
St Paul Hospital Millennium Medical College
Addis Ababa, Addis Ababa
About this study
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.
Read the detailed description
Chronic viral hepatitis is a major health problem globally. Each year nearly one million deaths are attributable to either hepatitis B or C. In Ethiopia 5-10% of the general population are infected with hepatitis B. Oral antiviral treatment of hepatitis B exists, but high costs and advanced laboratory requirements have been barriers to offer such treatment in resource-limited settings, resembling the situation in treatment of HIV/AIDS a decade ago.
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
- Hepatitis B
- Being tested
- Tenofovir disoproxil
- Keywords
- Liver cirrhosis, Antiviral agents, Liver diseases
- Medical subject headings
- Hepatitis B, Liver Cirrhosis, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir disoproxilDrug
| Study group | Role | What they receive |
|---|---|---|
| Urban | HBV patients in Addis Abeba. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD. Receives: Drug: Tenofovir disoproxil | |
| Rural | HBV patients in Adama, Afar, Jigjiga and Jimma. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD. Receives: Drug: Tenofovir disoproxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (3)
Viral suppression and genotypic resistance
Proportion of patients with viral load suppression and absence of resistance after >1 year of antiviral treatment.
Measured: 3 years
Regression of liver inflammation/fibrosis
Proportion of patients with normalization of ALT and improvement of liver stiffness (by transient elastography)
Measured: 3 years
Adherence to therapy
Proportion of patients with >95% adherence measured by pill count and visual analogue scale
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Addis Ababa University, The Research Council of Norway, University of Agder, South-Eastern Norway Regional Health Authority, St. Paul's Hospital Millennium Medical College, Ethiopia, Haramaya University,Ethiopia
- Responsible party
- Principal investigator, Asgeir Johannessen, Oslo University Hospital
- Investigators
- Asgeir Johannessen, MD PhD, Principal investigator, Oslo University HospitalNega Berhe, MD PhD, Principal investigator, Addis Abeba University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344498
- Sponsor's protocol ID
- 2014/1146
- Status last verified
- Nov 2024
- First submitted
- 16 Jan 2015
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 41109262Desalegn H, Yang X, Yen YS, Berhe N, Kenney B, Siwo GH, Tang W, Zhu J, Waljee AK, Johannessen A. Machine-learning methodologies to predict disease progression in chronic hepatitis B in Africa. Hepatol Commun. 2024 Nov 15;8(12):e0584. doi: 10.1097/HC9.0000000000000584. eCollection 2024 Dec 1.
PubMed 39774109Desalegn 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.
PubMed 37775742Desalegn 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.
PubMed 31092203Aberra 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.
PubMed 30929749Desalegn 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.
PubMed 30554571Aberra 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.
PubMed 28980394Aberra 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.
PubMed 28629395Desalegn 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.
PubMed 28222249
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa
- ClinicalTrials.gov ID
- NCT02344498
- Acronym / sponsor ID
- 2014/1146
- Conditions
- Hepatitis B
- Keywords
- Liver cirrhosis, Antiviral agents, Liver diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 7,350 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Addis Ababa University, The Research Council of Norway, University of Agder, South-Eastern Norway Regional Health Authority, St. Paul's Hospital Millennium Medical College, Ethiopia, Haramaya University,Ethiopia
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic viral hepatitis is a major health problem globally. Each year nearly one million deaths are attributable to either hepatitis B or C. In Ethiopia 5-10% of the general population are infected with hepatitis B. Oral antiviral treatment of hepatitis B exists, but high costs and advanced laboratory requirements have been barriers to offer such treatment in resource-limited settings, resembling the situation in treatment of HIV/AIDS a decade ago.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urban | – | Drug: Tenofovir disoproxilHBV patients in Addis Abeba. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD. |
| Rural | – | Drug: Tenofovir disoproxilHBV patients in Adama, Afar, Jigjiga and Jimma. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults with a positive HBsAg rapid test are eligible for inclusion.
Key inclusion criteria (1 listed)
- Consenting adults (≥18 years) residing in Ethiopia who are HBsAg positive
Key exclusion criteria (1 listed)
- Children <18 years, other terminal disease (cancer etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir disoproxil | Drug | Rural, Urban |
Primary outcome
Death, HCC or decompensated cirrhosis
Time frame: 3 years
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 secondary outcomes
Viral suppression and genotypic resistance
Time frame: 3 years
Regression of liver inflammation/fibrosis
Time frame: 3 years
Adherence to therapy
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Derived from this study: PubMed 41109262Rossvoll 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.
- Derived from this study: PubMed 39774109Desalegn H, Yang X, Yen YS, Berhe N, Kenney B, Siwo GH, Tang W, Zhu J, Waljee AK, Johannessen A. Machine-learning methodologies to predict disease progression in chronic hepatitis B in Africa. Hepatol Commun. 2024 Nov 15;8(12):e0584. doi: 10.1097/HC9.0000000000000584. eCollection 2024 Dec 1.
- Derived from this study: PubMed 37775742Desalegn 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.
- Derived from this study: PubMed 31092203Desalegn 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.
- Derived from this study: PubMed 30929749Aberra 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.
- Derived from this study: PubMed 30554571Desalegn 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.
- Derived from this study: PubMed 28980394Aberra 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.
- Derived from this study: PubMed 28629395Aberra 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.
- Derived from this study: PubMed 28222249Desalegn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asgeir Johannessen, MD PhD principal investigator
Oslo University Hospital
Nega Berhe, MD PhD principal investigator
Addis Abeba University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by Oslo University Hospital at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death, HCC or decompensated cirrhosis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02344498, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.