Hepatitis B, ChronicWATCHNCT02129829
PROLIFICA - West African Treatment Cohort for Hepatitis B
An observational study of Hepatitis B, Chronic and Hepatocellular Carcinoma, run by Imperial College London at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic, Hepatocellular Carcinoma
- What is being tested?
- Tenofovir disoproxil
- How many people
- 1,079 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2011to 31 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults are included for community screening. Selection criteria (below) are applied for recruitment into cohorts
Who may be able to join
- Adult Informed consent HBsAg positive Resident in Gambia or Senegal
Who cannot join
- HIV infection HCV infection Known liver cancer
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Prevention of Liver Fibrosis and Cancer in Africa. Observational Study of Screening, Assessment and Treatment for Chronic Hepatitis B Virus Infection
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.
Read the detailed description
Objectives Primary:
To determine whether suppression of HBV with a nucleotide analogue reduces the risk of liver cancer in West African populations.
Secondary:
To demonstrate that HBV replication can be effectively suppressed with a nucleotide analogue in West African populations To evaluate whether European treatment guidelines are applicable in West Africa To establish the applicability and efficacy of population based screening, clinical assessment and treatment in West Africa To enumerate the proportion of the adult population who carry HBV To evaluate the proportion of the HBV infected population who meet European Association for Study of the Liver (EASL) criteria for treatment
Endpoints Primary:
Incidence of Hepatocellular Carcinoma over the period of study in a treated cohort of patients with chronic HBV compared to historical controls
Secondary:
Proportion of adult population in Gambia and Senegal with chronic HBV infection Proportion of patients with chronic HBV infection who meet EASL treatment criteria Proportion of patients with undetectable HBV DNA < 400 copies/ml at 1, 2, 3, 4 and 5 years of treatment.
Incidence of hepatocellular Carcinoma in patients who do not meet EASL treatment criteria.
Treatment adherence rate. Average change in Fibroscan score after 3 and 5 years of treatment Emergence of resistance to treatment
Study Phase 4
Study Design A two part study:
Part 1 - Population based screening for HBV infection using a point-of-care test.
Part 2 - Non-randomised, open label, treatment cohort with parallel observation cohort
Number of Subjects Part 1:
Approximately 13,500 adults from the general population.
Part 2:
300 subjects in the treatment group 600 subjects in the observation group
Study Population Part 1:
Males and females aged over 30 years
Part 2:
Patients with chronic hepatitis B virus infection identified through population based screening.
Treatment Cohort There will be a single treatment group of 300 patients who meet EASL treatment criteria.
Schedule of Study Visits Part 1:
A single visit to an individual at their home or workplace when screening for HBV infection will be performed using a point-of-care test..
Part 2:
One screening visit will be performed to determine viral load, liver function tests, clinical examination, ultrasound examination and liver fibrosis assessment.
A second visit, 1 - 3 months later, will be used to verify viral load and ALT values
For those on treatment cohort:
A baseline visit will take place 2 weeks after the second screening visit and study drug will be dispensed with instructions for the patient.
First follow-up will be at 1 month to check adherence Second follow-up will be at 3 months for viral load and liver functions tests Treatment subjects will be seen every 3 months to dispense study drug and check compliance Viral load, liver function, renal function, AFP and ultrasound will be performed every 6 months.
Serum/plasma and urine samples for biomarkers of cancer development will be taken at baseline and annually.
Population Screening (Part 1 only) Communities will be sensitised about the study prior to visits by fieldworkers to individual homes, places of work or recreational facilities. A point-of-care test based on the detection of hepatitis B surface antigen (HBsAg) in a finger-prick blood sample will be used for screening. Subjects with a positive test will be given a hospital appointment for full clinical assessment.
Efficacy Evaluations (Part 2 only) Detection of liver cancer - Surveillance for liver cancer will be made using ultrasound and serum AFP every 6 months on all subjects. In some centres further imaging will be available.
Liver cancer will be diagnosed according to the following criteria:
- Liver mass with typical features of hepatocellular carcinoma on two imaging modalities (ultrasound, bubble ultrasound or CT), or
- liver mass on ultrasound and AFP > 400 iu/ml or
- histological or cytological confirmation of diagnosis.
Viral Load - viral load will be measure on EDTA plasma samples using an in-house real-time PCR assay verified for accuracy against commercial assays every 6 months.
Safety Evaluations (Part 2 only) Liver function tests, serum phosphate and renal function will be tested every 6 months
Evaluation of treatment guidelines Subjects who do not meet the EASL treatment criteria at baseline will be enrolled in the observational study with surveillance for liver cancer every 6 months
Detection of viral resistance Viral load monitoring of patients in the treatment study every 6 months will be used to detect possible virological resistance. A rise in viral load from nadir values or reappearance of detectable viraemia in patients who had achieved undetectable viral load will be investigated for emergence of viral sequence variants and for adherence to therapy
- Conditions
- Hepatitis B, Chronic, Hepatocellular Carcinoma
- Being tested
- Tenofovir disoproxil
- Keywords
- Cirrhosis, HBV, HIV, HCV
- Medical subject headings
- Hepatitis B, Chronic, Carcinoma, Hepatocellular, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir disoproxilDrug
Also called Viread
Tenofovir disoproxil 245 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Tenofovir disoproxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HCC or decompensated cirrhosis
Subjects will be reviewed 6 monthly with liver biochemistry and ultrasound to detect onset of hepatocellular carcinoma or decompensated cirrhosis
Measured: 5 years
Secondary outcomes (4)
Uptake of screening
Proportion of community subjects who accept screening tests
Measured: 2 years
Prevalence of HBV infection
Proportion of patients who test positive for HBsAg
Measured: 2 years
Rate of linkage into care
Proportion of patients who test positive for HBsAg who attend clinic for assessment
Measured: 2 years
Treatment rate
Proportion of patients with HBsAg who meet EASL treatment criteria
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startOct 2011
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,079 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Mark Thursz, MD FRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129829
- Sponsor's protocol ID
- WMDH-P34114
- Acronym
- WATCH
- Status last verified
- Sep 2020
- First submitted
- 30 Apr 2014
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lemoine 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.
PubMed 24308698Lemoine 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.
PubMed 27443781Nayagam 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.
PubMed 27443782Shimakawa 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.
PubMed 31102406Shimakawa 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.
PubMed 30104154Lemoine M, Shimakawa Y, Nayagam S, Khalil M, Suso P, Lloyd J, Goldin R, Njai HF, Ndow G, Taal M, Cooke G, D'Alessandro U, Vray M, Mbaye PS, Njie R, Mallet V, Thursz M. The gamma-glutamyl transpeptidase to platelet ratio (GPR) predicts significant liver fibrosis and cirrhosis in patients with chronic HBV infection in West Africa. Gut. 2016 Aug;65(8):1369-76. doi: 10.1136/gutjnl-2015-309260. Epub 2015 Jun 24.
PubMed 26109530Shimakawa Y, Lemoine M, Bottomley C, Njai HF, Ndow G, Jatta A, Tamba S, Bojang L, Taal M, Nyan O, D'Alessandro U, Njie R, Thursz M, Hall AJ. Birth order and risk of hepatocellular carcinoma in chronic carriers of hepatitis B virus: a case-control study in The Gambia. Liver Int. 2015 Oct;35(10):2318-26. doi: 10.1111/liv.12814. Epub 2015 Mar 11.
PubMed 25728498Njai HF, Shimakawa Y, Sanneh B, Ferguson L, Ndow G, Mendy M, Sow A, Lo G, Toure-Kane C, Tanaka J, Taal M, D'alessandro U, Njie R, Thursz M, Lemoine M. Validation of rapid point-of-care (POC) tests for detection of hepatitis B surface antigen in field and laboratory settings in the Gambia, Western Africa. J Clin Microbiol. 2015 Apr;53(4):1156-63. doi: 10.1128/JCM.02980-14. Epub 2015 Jan 28.
PubMed 25631805Shimakawa Y, Lemoine M, Njai HF, Bottomley C, Ndow G, Goldin RD, Jatta A, Jeng-Barry A, Wegmuller R, Moore SE, Baldeh I, Taal M, D'Alessandro U, Whittle H, Njie R, Thursz M, Mendy M. Natural history of chronic HBV infection in West Africa: a longitudinal population-based study from The Gambia. Gut. 2016 Dec;65(12):2007-2016. doi: 10.1136/gutjnl-2015-309892. Epub 2015 Jul 16.
PubMed 26185161Shimakawa Y, Lemoine M, Mendy M, Njai HF, D'Alessandro U, Hall A, Thursz M, Njie R. Population-based interventions to reduce the public health burden related with hepatitis B virus infection in the gambia, west Africa. Trop Med Health. 2014 Jun;42(2 Suppl):59-64. doi: 10.2149/tmh.2014-S08.
PubMed 25425952Shimakawa Y, Takao Y, Anderson ST, Taal M, Yamaguchi T, Giana L, Ndow G, Sarr L, Kambi A, Njai HF, Bottomley C, Nyan O, Sabally S, D'Alessandro U, Taylor-Robinson SD, Thursz M, Lemoine M, Njie R. The prevalence and burden of symptoms in patients with chronic liver diseases in The Gambia, West Africa. Palliat Med. 2015 Feb;29(2):184-5. doi: 10.1177/0269216314547103. Epub 2014 Sep 5. No abstract available.
PubMed 25193933
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Liver Fibrosis and Cancer in Africa. Observational Study of Screening, Assessment and Treatment for Chronic Hepatitis B Virus Infection
- ClinicalTrials.gov ID
- NCT02129829
- Acronym / sponsor ID
- WATCH / WMDH-P34114
- Conditions
- Hepatitis B, Chronic, Hepatocellular Carcinoma
- Keywords
- Cirrhosis, HBV, HIV, HCV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,079 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- 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
- Study start
- Oct 2011 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives Primary:
To determine whether suppression of HBV with a nucleotide analogue reduces the risk of liver cancer in West African populations.
Secondary:
To demonstrate that HBV replication can be effectively suppressed with a nucleotide analogue in West African populations To evaluate whether European treatment guidelines are applicable in West Africa To establish the applicability and efficacy of population based screening, clinical assessment and treatment in West Africa To enumerate the proportion of the adult population who carry HBV To evaluate the proportion of the HBV infected population who meet European Association for Study of the Liver (EASL) criteria for treatment
Endpoints Primary:
Incidence of Hepatocellular Carcinoma over the period of study in a treated cohort of patients with chronic HBV compared to historical controls
Secondary:
Proportion of adult population in Gambia and Senegal with chronic HBV infection Proportion of patients with chronic HBV infection who meet EASL treatment criteria Proportion of patients with undetectable HBV DNA < 400 copies/ml at 1, 2, 3, 4 and 5 years of treatment.
Incidence of hepatocellular Carcinoma in patients who do not meet EASL treatment criteria.
Treatment adherence rate. Average change in Fibroscan score after 3 and 5 years of treatment Emergence of resistance to treatment
Study Phase 4
Study Design A two part study:
Part 1 - Population based screening for HBV infection using a point-of-care test.
Part 2 - Non-randomised, open label, treatment cohort with parallel observation cohort
Number of Subjects Part 1:
Approximately 13,500 adults from the general population.
Part 2:
300 subjects in the treatment group 600 subjects in the observation group
Study Population Part 1:
Males and females aged over 30 years
Part 2:
Patients with chronic hepatitis B virus infection identified through population based screening.
Treatment Cohort There will be a single treatment group of 300 patients who meet EASL treatment criteria.
Schedule of Study Visits Part 1:
A single visit to an individual at their home or workplace when screening for HBV infection will be performed using a point-of-care test..
Part 2:
One screening visit will be performed to determine viral load, liver function tests, clinical examination, ultrasound examination and liver fibrosis assessment.
A second visit, 1 - 3 months later, will be used to verify viral load and ALT values
For those on treatment cohort:
A baseline visit will take place 2 weeks after the second screening visit and study drug will be dispensed with instructions for the patient.
First follow-up will be at 1 month to check adherence Second follow-up will be at 3 months for viral load and liver functions tests Treatment subjects will be seen every 3 months to dispense study drug and check compliance Viral load, liver function, renal function, AFP and ultrasound will be performed every 6 months.
Serum/plasma and urine samples for biomarkers of cancer development will be taken at baseline and annually.
Population Screening (Part 1 only) Communities will be sensitised about the study prior to visits by fieldworkers to individual homes, places of work or recreational facilities. A point-of-care test based on the detection of hepatitis B surface antigen (HBsAg) in a finger-prick blood sample will be used for screening. Subjects with a positive test will be given a hospital appointment for full clinical assessment.
Efficacy Evaluations (Part 2 only) Detection of liver cancer - Surveillance for liver cancer will be made using ultrasound and serum AFP every 6 months on all subjects. In some centres further imaging will be available.
Liver cancer will be diagnosed according to the following criteria:
- Liver mass with typical features of hepatocellular carcinoma on two imaging modalities (ultrasound, bubble ultrasound or CT), or
- liver mass on ultrasound and AFP > 400 iu/ml or
- histological or cytological confirmation of diagnosis.
Viral Load - viral load will be measure on EDTA plasma samples using an in-house real-time PCR assay verified for accuracy against commercial assays every 6 months.
Safety Evaluations (Part 2 only) Liver function tests, serum phosphate and renal function will be tested every 6 months
Evaluation of treatment guidelines Subjects who do not meet the EASL treatment criteria at baseline will be enrolled in the observational study with surveillance for liver cancer every 6 months
Detection of viral resistance Viral load monitoring of patients in the treatment study every 6 months will be used to detect possible virological resistance. A rise in viral load from nadir values or reappearance of detectable viraemia in patients who had achieved undetectable viral load will be investigated for emergence of viral sequence variants and for adherence to therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) | – | Drug: Tenofovir disoproxilPatients who meet EASL treatment criteria who receive Tenofovir disoproxil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults are included for community screening. Selection criteria (below) are applied for recruitment into cohorts
Key inclusion criteria (1 listed)
- Adult Informed consent HBsAg positive Resident in Gambia or Senegal
Key exclusion criteria (1 listed)
- HIV infection HCV infection Known liver cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir disoproxilAlso: VireadTenofovir disoproxil 245 mg once daily | Drug | Treatment Group (Tenofovir disoproxil) |
Primary outcome
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
4 secondary outcomes
Uptake of screening
Time frame: 2 years
Prevalence of HBV infection
Time frame: 2 years
Rate of linkage into care
Time frame: 2 years
Treatment rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Background: PubMed 24308698Lemoine 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.
- Background: PubMed 27443781Lemoine 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.
- Background: PubMed 27443782Nayagam 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.
- Background: PubMed 31102406Shimakawa 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.
- Background: PubMed 30104154Shimakawa 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.
- Background: PubMed 26109530Lemoine M, Shimakawa Y, Nayagam S, Khalil M, Suso P, Lloyd J, Goldin R, Njai HF, Ndow G, Taal M, Cooke G, D'Alessandro U, Vray M, Mbaye PS, Njie R, Mallet V, Thursz M. The gamma-glutamyl transpeptidase to platelet ratio (GPR) predicts significant liver fibrosis and cirrhosis in patients with chronic HBV infection in West Africa. Gut. 2016 Aug;65(8):1369-76. doi: 10.1136/gutjnl-2015-309260. Epub 2015 Jun 24.
- Background: PubMed 25728498Shimakawa Y, Lemoine M, Bottomley C, Njai HF, Ndow G, Jatta A, Tamba S, Bojang L, Taal M, Nyan O, D'Alessandro U, Njie R, Thursz M, Hall AJ. Birth order and risk of hepatocellular carcinoma in chronic carriers of hepatitis B virus: a case-control study in The Gambia. Liver Int. 2015 Oct;35(10):2318-26. doi: 10.1111/liv.12814. Epub 2015 Mar 11.
- Background: PubMed 25631805Njai HF, Shimakawa Y, Sanneh B, Ferguson L, Ndow G, Mendy M, Sow A, Lo G, Toure-Kane C, Tanaka J, Taal M, D'alessandro U, Njie R, Thursz M, Lemoine M. Validation of rapid point-of-care (POC) tests for detection of hepatitis B surface antigen in field and laboratory settings in the Gambia, Western Africa. J Clin Microbiol. 2015 Apr;53(4):1156-63. doi: 10.1128/JCM.02980-14. Epub 2015 Jan 28.
- Background: PubMed 26185161Shimakawa Y, Lemoine M, Njai HF, Bottomley C, Ndow G, Goldin RD, Jatta A, Jeng-Barry A, Wegmuller R, Moore SE, Baldeh I, Taal M, D'Alessandro U, Whittle H, Njie R, Thursz M, Mendy M. Natural history of chronic HBV infection in West Africa: a longitudinal population-based study from The Gambia. Gut. 2016 Dec;65(12):2007-2016. doi: 10.1136/gutjnl-2015-309892. Epub 2015 Jul 16.
- Background: PubMed 25425952Shimakawa Y, Lemoine M, Mendy M, Njai HF, D'Alessandro U, Hall A, Thursz M, Njie R. Population-based interventions to reduce the public health burden related with hepatitis B virus infection in the gambia, west Africa. Trop Med Health. 2014 Jun;42(2 Suppl):59-64. doi: 10.2149/tmh.2014-S08.
- Derived from this study: PubMed 25193933Shimakawa Y, Takao Y, Anderson ST, Taal M, Yamaguchi T, Giana L, Ndow G, Sarr L, Kambi A, Njai HF, Bottomley C, Nyan O, Sabally S, D'Alessandro U, Taylor-Robinson SD, Thursz M, Lemoine M, Njie R. The prevalence and burden of symptoms in patients with chronic liver diseases in The Gambia, West Africa. Palliat Med. 2015 Feb;29(2):184-5. doi: 10.1177/0269216314547103. Epub 2014 Sep 5. No abstract available.
- Individual participant dataSharing planned: No
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Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Thursz, MD FRCP principal investigator
Imperial College London
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, Chronic and Hepatocellular Carcinoma, run by Imperial College London at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Senegal, The Gambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of HCC or decompensated cirrhosis (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02129829, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.