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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Imperial College London
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT02129829
First received: April 30, 2014
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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 Intervention
Hepatitis B, Chronic
Hepatocellular Carcinoma
Drug: Tenofovir disoproxil

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Incidence of HCC or decompensated cirrhosis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Subjects will be reviewed 6 monthly with liver biochemistry and ultrasound to detect onset of hepatocellular carcinoma or decompnsated cirrhosis


Secondary Outcome Measures:
  • Uptake of screening [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Proportion of community subjects who accept screening tests

  • Prevalence of HBV infection [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Proportion of patients who test positive for HBsAg

  • Rate of linkage into care [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Proportion of patients who test positive for HBsAg who attend clinic for assessment

  • Treatment rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Proportion of patients with HBsAg who meet EASL treatment criteria


Other Outcome Measures:
  • Relaibility of PoC test [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Sensitivity and specificity of capillary blood sample HBsAg test applied at point of care

  • Accuracy of non-invasive fibrosis assessment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 1000
Study Start Date: October 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

  • Adult Informed consent HBsAg positive Resident in Gambia or Senegal

Exclusion Criteria:

  • HIV infection HCV infection Known liver cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02129829

Contacts
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

Locations
Gambia
MRC Laboratories Hospital Recruiting
Fajara, Gambia
Contact: Ramou Njie, MBBS FRCP       r.njie@mrc.gm   
Senegal
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
Investigators
Principal Investigator: Mark Thursz, MD FRCP Imperial College London
  More Information

Publications:
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02129829     History of Changes
Other Study ID Numbers: WMDH-P34114
Study First Received: April 30, 2014
Last Updated: April 30, 2014
Health Authority: Gambia: MRC Ethics Committee

Keywords provided by Imperial College London:
Cirrhosis
HBV
HIV
HCV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Hepatitis, Viral, Human
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 22, 2014