Clinical trial · Observational
PROLIFICA - West African Treatment Cohort for Hepatitis B
Prevention of Liver Fibrosis and Cancer in Africa. Observational Study of Screening, Assessment and Treatment for Chronic Hepatitis B Virus Infection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatitis B, Chronic | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tenofovir disoproxil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Observational Group
- description
- Patients whose viral load, ALT value and fibrosis status does not meet EASL criteria for treatment and are observed 6 monthly
- label
- Treatment Group (Tenofovir disoproxil)
- description
- Patients who meet EASL treatment criteria who receive Tenofovir disoproxil
- interventionNames
- Drug: Tenofovir disoproxil
Primary outcomes (1)
- measure
- Incidence of HCC or decompensated cirrhosis
- timeFrame
- 5 years
- description
- Subjects will be reviewed 6 monthly with liver biochemistry and ultrasound to detect onset of hepatocellular carcinoma or decompensated cirrhosis
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult Informed consent HBsAg positive Resident in Gambia or Senegal Exclusion Criteria: * HIV infection HCV infection Known liver cancer
References
Publications (11)
- BACKGROUNDLemoine M, Shimakawa Y, Njie R, Njai HF, Nayagam S, Khalil M, Goldin R, Ingiliz P, Taal M, Nyan O, Corrah T, D'Alessandro U, Thursz M. Food intake increases liver stiffness measurements and hampers reliable values in patients with chronic hepatitis B and healthy controls: the PROLIFICA experience in The Gambia. Aliment Pharmacol Ther. 2014 Jan;39(2):188-96. doi: 10.1111/apt.12561. Epub 2013 Dec 5. PMID 24308698
- BACKGROUNDLemoine M, Shimakawa Y, Njie R, Taal M, Ndow G, Chemin I, Ghosh S, Njai HF, Jeng A, Sow A, Toure-Kane C, Mboup S, Suso P, Tamba S, Jatta A, Sarr L, Kambi A, Stanger W, Nayagam S, Howell J, Mpabanzi L, Nyan O, Corrah T, Whittle H, Taylor-Robinson SD, D'Alessandro U, Mendy M, Thursz MR; PROLIFICA investigators. Acceptability and feasibility of a screen-and-treat programme for hepatitis B virus infection in The Gambia: the Prevention of Liver Fibrosis and Cancer in Africa (PROLIFICA) study. Lancet Glob Health. 2016 Aug;4(8):e559-67. doi: 10.1016/S2214-109X(16)30130-9. PMID 27443781
- BACKGROUNDNayagam S, Conteh L, Sicuri E, Shimakawa Y, Suso P, Tamba S, Njie R, Njai H, Lemoine M, Hallett TB, Thursz M. Cost-effectiveness of community-based screening and treatment for chronic hepatitis B in The Gambia: an economic modelling analysis. Lancet Glob Health. 2016 Aug;4(8):e568-78. doi: 10.1016/S2214-109X(16)30101-2. PMID 27443782
- BACKGROUNDShimakawa Y, Ndow G, Njie R, Njai HF, Takahashi K, Akbar SMF, Cohen D, Nayagam S, Jeng A, Ceesay A, Sanneh B, Baldeh I, Imaizumi M, Moriyama K, Aoyagi K, D'Alessandro U, Mishiro S, Chemin I, Mendy M, Thursz MR, Lemoine M. Hepatitis B Core-related Antigen: An Alternative to Hepatitis B Virus DNA to Assess Treatment Eligibility in Africa. Clin Infect Dis. 2020 Mar 17;70(7):1442-1452. doi: 10.1093/cid/ciz412. PMID 31102406
- BACKGROUNDShimakawa Y, Njie R, Ndow G, Vray M, Mbaye PS, Bonnard P, Sombie R, Nana J, Leroy V, Bottero J, Ingiliz P, Post G, Sanneh B, Baldeh I, Suso P, Ceesay A, Jeng A, Njai HF, Nayagam S, D'Alessandro U, Chemin I, Mendy M, Thursz M, Lemoine M. Development of a simple score based on HBeAg and ALT for selecting patients for HBV treatment in Africa. J Hepatol. 2018 Oct;69(4):776-784. doi: 10.1016/j.jhep.2018.05.024. Epub 2018 Jul 1.