Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02344498

Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Fibrosis Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Paul Hospital Millennium Medical College

Addis Ababa, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consenting adults (≥18 years) residing in Ethiopia who are HBsAg positive

Exclusion criteria

  • Children <18 years, other terminal disease (cancer etc.)

Treatment and study plan

Tenofovir disoproxil

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. Viral suppression and genotypic resistance

    Time frame: 3 years

    Proportion of patients with viral load suppression and absence of resistance after >1 year of antiviral treatment.

  2. Regression of liver inflammation/fibrosis

    Time frame: 3 years

    Proportion of patients with normalization of ALT and improvement of liver stiffness (by transient elastography)

  3. Adherence to therapy

    Time frame: 3 years

    Proportion of patients with >95% adherence measured by pill count and visual analogue scale

Other outcomes

  1. Sensitivity and specificity of HBsAg rapid tests

    Time frame: 1 year

    Sensitivity and specificity of commonly used HBsAg rapid tests compared to a gold standard ELISA method

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Addis Ababa University
  • Haramaya University,Ethiopia
  • South-Eastern Norway Regional Health Authority
  • St. Paul's Hospital Millennium Medical College, Ethiopia
  • The Research Council of Norway
  • University of Agder

Registry information

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2015
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.