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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02344498
• Other study ID #: 2014/1146
• Status: Active, not recruiting
• Start date: January 2015
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1350
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Drug:
• Tenofovir disoproxil

Locations

Country	Name	City	State
Ethiopia	St Paul Hospital Millennium Medical College	Addis Abeba

Sponsors (7)

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

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sensitivity and specificity of HBsAg rapid tests	Sensitivity and specificity of commonly used HBsAg rapid tests compared to a gold standard ELISA method	1 year
Primary	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	Viral suppression and genotypic resistance	Proportion of patients with viral load suppression and absence of resistance after >1 year of antiviral treatment.	3 years
Secondary	Regression of liver inflammation/fibrosis	Proportion of patients with normalization of ALT and improvement of liver stiffness (by transient elastography)	3 years
Secondary	Adherence to therapy	Proportion of patients with >95% adherence measured by pill count and visual analogue scale	3 years