Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study

Mayo Clinic logo

Mayo Clinic

Status

Active, not recruiting

Conditions

Hepatitis B, Chronic
Hepatitis B

Study type

Observational

Funder types

Other

Identifiers

NCT02766933
16-001716

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

hepatitis B cohort
Description:
CBCHB employees and/or spouses found to be hepatitis B surface antigen positive on screening

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems