An observational study in Hepatitis B and Hepatitis B, Chronic, sponsored by Mayo Clinic. Completed at 1 site in Cameroon. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-20.
Sponsored by Mayo Clinic · Observational
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.
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:
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.
895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.
This study's enrollment of 207 is below the median of 400 across 206 observational studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Compared within Hepatitis B, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hepatitis B. The counts are of registry records indexed under each term, refreshed daily. How we classify →
CBCHB employees and their spouses who are found to be hepatitis B surface antigen positive during screening.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CBCHB employees and/or spouses found to be hepatitis B surface antigen positive on screening
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 years
Plan to share: No
The record gives a start of May 2016, a primary completion of Dec 2024 and a completion of Dec 2024. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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