NCT02766933

Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 207 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B
• Hepatitis B, Chronic

Timeline

• Start date: 2016-05-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2016-05-10
• Last updated: 2025-01-20

Locations

1 site across 1 country: Cameroon