This trial is active, not recruiting.

Condition hepatitis b
Treatment tenofovir disoproxil
Sponsor Oslo University Hospital
Collaborator Addis Ababa University
Start date January 2015
End date December 2017
Trial size 1350 participants
Trial identifier NCT02344498, 2014/1146


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
HBV patients in Addis Abeba. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.
tenofovir disoproxil
HBV patients in Harar. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.
tenofovir disoproxil

Primary Outcomes

Death, HCC or decompensated cirrhosis
time frame: 3 years

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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Consenting adults (≥18 years) residing in Ethiopia who are HBsAg positive Exclusion Criteria: - Children <18 years, other terminal disease (cancer etc.)

Additional Information

Official title Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa
Principal investigator Asgeir Johannessen, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Oslo University Hospital.