Hepatitis BNCT02766933
Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study
An observational study of Hepatitis B and Hepatitis B, Chronic, run by Mayo Clinic at 1 site in Cameroon.
Trial summary
The natural history and response to therapy of chronic hepatitis B infection in West Africa are currently poorly understood. In this study, employees of the Cameroon Baptist Convention Health Board (CBCHB) and spouses who are found to be hepatitis B positive on screening will be offered enrollment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Hepatitis B, Chronic
- How many people
- 207 participants
- Where
- 1 siteCameroon
- Study dates
- May 2016to 31 Dec 2024
- How long will I take part?
- 5 Years
- 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: CBCHB employees and their spouses who are found to be hepatitis B surface antigen positive during screening.
Who may be able to join
- Age at least 18yrs.
- CBCHB employee or spouse of an employee.
- Able to provide written informed consent.
- Willing to comply with follow-up visits.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The natural history and response to therapy of chronic hepatitis B infection in West Africa are currently poorly understood. In this study, employees of the Cameroon Baptist Convention Health Board (CBCHB) and spouses who are found to be hepatitis B positive on screening will be offered enrollment. Disease monitoring and treatment will be provided following current WHO guidelines. Clinical data will be prospectively recorded for 5 years, and bio-specimens will be frozen for future analysis.
Read the detailed description
Chronic hepatitis B (CHB) is common in Cameroon, and hepatitis B-related hepatocellular carcinoma is a leading cause of cancer death throughout West and Central Africa. Little is known about the natural history of CHB in sub-Saharan Africa and the long term response to antiviral therapy. The study hypothesis is that these can be determined by prospective follow-up of a population-based cohort.
Aims, purpose, or objectives:
- To determine the characteristics of a population of asymptomatic Cameroonian adults who work for the Cameroon Baptist Convention Health Board (CBCHB) who have chronic hepatitis B infection.
- To determine the phase of infection into which these Hepatitis B carriers fall.
- To determine the incidence and risk factors for cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma in this cohort over time.
- To offer treatment according to a standardized protocol, and to determine the outcome of treatment.
- To archive serum samples from patients for potential future studies of specific markers associated with hepatitis B and liver disease outcomes.
Methods: Adult employees of the Cameroon Baptist Convention Health Board (CBCHB) and their spouses who are known to be positive for hepatitis B surface antigen (HBsAg+) will be offered the enrollment in a cohort study for CHB. Following enrollment, their stage of disease will be determined using clinical, laboratory and imaging studies. Patients will then be followed at regular intervals for 5 years. Antiviral therapy will be offered to patients who qualify according to current World Health Organization guidelines.
Significance: This protocol will prospectively determine the scope of CHB-related illness in an initially asymptomatic, population-based cohort and the outcomes of current WHO treatment guidelines in this African cohort.
- Conditions
- Hepatitis B, Hepatitis B, Chronic
- Keywords
- tenofovir, hepatocellular carcinoma, cirrhosis
- Medical subject headings
- Hepatitis B, 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.
| Study group | Role | What they receive |
|---|---|---|
| hepatitis B cohort | CBCHB employees and/or spouses found to be hepatitis B surface antigen positive on screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects in each phase of chronic hepatitis B infection at enrollment
distribution of subjects across the 4 phases of chronic hepatitis B at enrollment (immune tolerant, immune clearance, inactive carrier, and reactivation phases). This is determined by enrollment age, ALT, HBeAg status, clinical and imaging findings of cirrhosis, and (in some cases) serum hepatitis B DNA quantification
Measured: Enrollment
yearly incidence of compensated and decompensated cirrhosis in the study cohort
incidence of compensated and decompensated cirrhosis over time in the study cohort, as determined by interval history, physical exam, APRI (AST to platelet ratio index), and ultrasound findings
Measured: 5 years
yearly incidence of hepatocellular carcinoma in the study cohort
incidence of hepatocellular carcinoma over time in the study cohort as determined by serum alpha fetoprotein, per-protocol imaging studies, and biopsy when appropriate
Measured: 5 years
Percentage of treated subjects who achieve and maintain a complete response to antiviral treatment.
Percentage of subjects receiving antiviral treatment who achieve and maintain a complete response as determined by normalization of serum transaminases and (in some cases) loss of detectable serum hepatitis B DNA
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startMay 2016
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 207 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Cameroon Baptist Convention Health
- Responsible party
- Principal investigator, Lewis R. Roberts, Mayo Clinic
- Investigators
- Norah Nyah, M.D., Principal investigator, Cameroon Baptist Convention Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766933
- Sponsor's protocol ID
- 16-001716
- Status last verified
- Jan 2025
- First submitted
- 20 Apr 2016
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study
- ClinicalTrials.gov ID
- NCT02766933
- Acronym / sponsor ID
- 16-001716
- Conditions
- Hepatitis B, Hepatitis B, Chronic
- Keywords
- tenofovir, hepatocellular carcinoma, cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Cameroon Baptist Convention Health
- Study start
- May 2016
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 May 2016 (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 natural history and response to therapy of chronic hepatitis B infection in West Africa are currently poorly understood. In this study, employees of the Cameroon Baptist Convention Health Board (CBCHB) and spouses who are found to be hepatitis B positive on screening will be offered enrollment. Disease monitoring and treatment will be provided following current WHO guidelines. Clinical data will be prospectively recorded for 5 years, and bio-specimens will be frozen for future analysis.
Detailed description
Chronic hepatitis B (CHB) is common in Cameroon, and hepatitis B-related hepatocellular carcinoma is a leading cause of cancer death throughout West and Central Africa. Little is known about the natural history of CHB in sub-Saharan Africa and the long term response to antiviral therapy. The study hypothesis is that these can be determined by prospective follow-up of a population-based cohort.
Aims, purpose, or objectives:
- To determine the characteristics of a population of asymptomatic Cameroonian adults who work for the Cameroon Baptist Convention Health Board (CBCHB) who have chronic hepatitis B infection.
- To determine the phase of infection into which these Hepatitis B carriers fall.
- To determine the incidence and risk factors for cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma in this cohort over time.
- To offer treatment according to a standardized protocol, and to determine the outcome of treatment.
- To archive serum samples from patients for potential future studies of specific markers associated with hepatitis B and liver disease outcomes.
Methods: Adult employees of the Cameroon Baptist Convention Health Board (CBCHB) and their spouses who are known to be positive for hepatitis B surface antigen (HBsAg+) will be offered the enrollment in a cohort study for CHB. Following enrollment, their stage of disease will be determined using clinical, laboratory and imaging studies. Patients will then be followed at regular intervals for 5 years. Antiviral therapy will be offered to patients who qualify according to current World Health Organization guidelines.
Significance: This protocol will prospectively determine the scope of CHB-related illness in an initially asymptomatic, population-based cohort and the outcomes of current WHO treatment guidelines in this African cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hepatitis B cohort | – | –CBCHB employees and/or spouses found to be hepatitis B surface antigen positive on screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CBCHB employees and their spouses who are found to be hepatitis B surface antigen positive during screening.
Key inclusion criteria (4 listed)
- Age at least 18yrs.
- CBCHB employee or spouse of an employee.
- Able to provide written informed consent.
- Willing to comply with follow-up visits.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of subjects in each phase of chronic hepatitis B infection at enrollment
Time frame: Enrollment
distribution of subjects across the 4 phases of chronic hepatitis B at enrollment (immune tolerant, immune clearance, inactive carrier, and reactivation phases). This is determined by enrollment age, ALT, HBeAg status, clinical and imaging findings of cirrhosis, and (in some cases) serum hepatitis B DNA quantification
yearly incidence of compensated and decompensated cirrhosis in the study cohort
Time frame: 5 years
incidence of compensated and decompensated cirrhosis over time in the study cohort, as determined by interval history, physical exam, APRI (AST to platelet ratio index), and ultrasound findings
yearly incidence of hepatocellular carcinoma in the study cohort
Time frame: 5 years
incidence of hepatocellular carcinoma over time in the study cohort as determined by serum alpha fetoprotein, per-protocol imaging studies, and biopsy when appropriate
Percentage of treated subjects who achieve and maintain a complete response to antiviral treatment.
Time frame: 5 years
Percentage of subjects receiving antiviral treatment who achieve and maintain a complete response as determined by normalization of serum transaminases and (in some cases) loss of detectable serum hepatitis B DNA
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 20 Jan 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Norah Nyah, M.D. principal investigator
Cameroon Baptist Convention Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B and Hepatitis B, Chronic, run by Mayo Clinic at 1 site in Cameroon.
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 4 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 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. 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?
Proportion of subjects in each phase of chronic hepatitis B infection at enrollment (time frame: Enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2025.