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

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ClinicalTrials.gov Identifier: NCT02344498
Recruitment Status : Active, not recruiting
First Posted : January 26, 2015
Last Update Posted : September 4, 2019
Sponsor:
Collaborators:
Addis Ababa University
The Research Council of Norway
University of Agder
South-Eastern Norway Regional Health Authority, Norway
St. Paul's Hospital Millennium Medical College, Ethiopia
Haramaya University,Ethiopia
Information provided by (Responsible Party):
Asgeir Johannessen, Oslo University Hospital

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.

Condition or disease Intervention/treatment
Hepatitis B Drug: Tenofovir disoproxil

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.


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Study Type : Observational
Actual Enrollment : 1350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa
Actual Study Start Date : January 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Urban
HBV patients in Addis Abeba. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.
Drug: Tenofovir disoproxil
Rural
HBV patients in Harar. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.
Drug: Tenofovir disoproxil



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adults with a positive HBsAg rapid test are eligible for inclusion.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344498


Locations
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Ethiopia
St Paul Hospital Millennium Medical College
Addis Abeba, Ethiopia
Sponsors and Collaborators
Oslo University Hospital
Addis Ababa University
The Research Council of Norway
University of Agder
South-Eastern Norway Regional Health Authority, Norway
St. Paul's Hospital Millennium Medical College, Ethiopia
Haramaya University,Ethiopia
Investigators
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Principal Investigator: Asgeir Johannessen, MD PhD Oslo University Hospital
Principal Investigator: Nega Berhe, MD PhD Addis Abeba University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Asgeir Johannessen, Researcher / project manager, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02344498     History of Changes
Other Study ID Numbers: 2014/1146
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Keywords provided by Asgeir Johannessen, Oslo University Hospital:
Liver cirrhosis
Antiviral agents
Liver diseases
Additional relevant MeSH terms:
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Hepatitis B
Tenofovir
Hepatitis A
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents