Clinical trial NCT02766933: Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study
Official title: Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Hepatitis B, Chronic
Keywords: tenofovir
hepatocellular carcinoma
cirrhosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Cameroon Baptist Convention Health
First posted: 2016-05-10
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CBCHB employees and their spouses who are found to be hepatitis B surface antigen positive during screening.

Brief 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. 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:

1. 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.
2. To determine the phase of infection into which these Hepatitis B carriers fall.
3. To determine the incidence and risk factors for cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma in this cohort over time.
4. To offer treatment according to a standardized protocol, and to determine the outcome of treatment.
5. 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.

Eligibility criteria: Inclusion Criteria:

* Age at least 18yrs.
* CBCHB employee or spouse of an employee.
* Able to provide written informed consent.
* Willing to comply with follow-up visits.

Exclusion Criteria:

* None

Primary outcomes:
measure: Proportion of subjects in each phase of chronic hepatitis B infection at enrollment
timeFrame: Enrollment
measure: yearly incidence of compensated and decompensated cirrhosis in the study cohort
timeFrame: 5 years
measure: yearly incidence of hepatocellular carcinoma in the study cohort
timeFrame: 5 years
measure: Percentage of treated subjects who achieve and maintain a complete response to antiviral treatment.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bamenda
country: Cameroon
facility: Mbingo Baptist Hospital
state: Northwest
Study officials:
affiliation: Cameroon Baptist Convention Health Board
name: Norah Nyah, M.D.
role: PRINCIPAL_INVESTIGATOR
References: