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PROLIFICA - West African Treatment Cohort for Hepatitis B (WATCH)

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ClinicalTrials.gov Identifier: NCT02129829
Recruitment Status : Unknown
Verified June 2011 by Imperial College London.
Recruitment status was:  Recruiting
First Posted : May 2, 2014
Last Update Posted : June 2, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
The West African Treatment Cohort for Hepatitis B (WATCH) study is a component of the European Commission Funded FP7 project PROLIFICA. It aims to evaluate a number of steps required to successfully treat patients with chronic hepatitis B virus infection to prevent cirrhosis and liver cancer. The first step is to determine whether screening for hepatitis B using a point of care test is feasible and effective. The second is to monitor linkage from screening into care. The third is to evaluate cheap non-invasive assessments to determine the need for treatment. The fourth is to determine what proportion of patients meet treatment eligibility criteria. The fifth step is to establish a treatment cohort which can be used to measure adherence to therapy and avoidance of HBV related complications. A parallel untreated cohort will be established to determine whether treatment criteria are relevant in this West African setting by monitoring for complications of HBV infection.

Condition or disease Intervention/treatment
Hepatitis B, Chronic Hepatocellular Carcinoma Drug: Tenofovir disoproxil

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevention of Liver Fibrosis and Cancer in Africa. Observational Study of Screening, Assessment and Treatment for Chronic Hepatitis B Virus Infection
Study Start Date : October 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Observational Group
Patients whose viral load, ALT value and fibrosis status does not meet EASL criteria for treatment and are observed 6 monthly
Treatment Group (Tenofovir disoproxil)
Patients who meet EASL treatment criteria who receive Tenofovir disoproxil
Drug: Tenofovir disoproxil
Tenofovir disoproxil 245 mg once daily
Other Name: Viread

Outcome Measures

Primary Outcome Measures :
  1. Incidence of HCC or decompensated cirrhosis [ Time Frame: 5 years ]
    Subjects will be reviewed 6 monthly with liver biochemistry and ultrasound to detect onset of hepatocellular carcinoma or decompensated cirrhosis

Secondary Outcome Measures :
  1. Uptake of screening [ Time Frame: 2 years ]
    Proportion of community subjects who accept screening tests

  2. Prevalence of HBV infection [ Time Frame: 2 years ]
    Proportion of patients who test positive for HBsAg

  3. Rate of linkage into care [ Time Frame: 2 years ]
    Proportion of patients who test positive for HBsAg who attend clinic for assessment

  4. Treatment rate [ Time Frame: 2 years ]
    Proportion of patients with HBsAg who meet EASL treatment criteria

Other Outcome Measures:
  1. Reliability of PoC test [ Time Frame: 2 years ]
    Sensitivity and specificity of capillary blood sample HBsAg test applied at point of care

  2. Accuracy of non-invasive fibrosis assessment [ Time Frame: 2 years ]
    Sensitivity, specificity and ROC analysis of Fibroscan, APRI and FIB4 tests compared to liver biopsy to assess liver fibrosis

Biospecimen Retention:   Samples With DNA
Serum, plasma, urine and DNA

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adults are included for community screening. Selection criteria (below) are applied for recruitment into cohorts

Inclusion Criteria:

  • Adult Informed consent HBsAg positive Resident in Gambia or Senegal

Exclusion Criteria:

  • HIV infection HCV infection Known liver cancer
Contacts and Locations

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): NCT02129829

Contact: Mark R Thursz, MD FRCP 0207 886 6454 m.thursz@imperial.ac.uk
Contact: Maud N Lemoine, MD PhD 0207 886 6454 m.lemoine@imperial.ac.uk

MRC Laboratories Hospital Recruiting
Fajara, Gambia
Contact: Ramou Njie, MBBS FRCP       r.njie@mrc.gm   
UFR Sante Thies, Recruiting
Thies, Senegal
Contact: Mourtalla Ka, MD       mmka@refer.sn   
Sponsors and Collaborators
Imperial College London
Medical Research Council Unit, The Gambia
Department of State for Health and Social Welfare, The Gambia
UFR Sante de Thies, Senegal
Cheikh Anta Diop University, Senegal
Institut National de la Santé Et de la Recherche Médicale, France
International Agency for Research on Cancer
Principal Investigator: Mark Thursz, MD FRCP Imperial College London
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02129829     History of Changes
Other Study ID Numbers: WMDH-P34114
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: June 2011

Keywords provided by Imperial College London:

Additional relevant MeSH terms:
Hepatitis A
Carcinoma, Hepatocellular
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action