Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study
Hepatitis B, Chronic
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||5 Years|
|Official Title:||Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study|
- Proportion of subjects in each phase of chronic hepatitis B infection at enrollment [ Time Frame: Enrollment ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
Biospecimen Retention: Samples Without DNA
|Study Start Date:||May 2016|
|Estimated Study Completion Date:||May 2022|
|Estimated Primary Completion Date:||May 2022 (Final data collection date for primary outcome measure)|
hepatitis B cohort
CBCHB employees and/or spouses found to be hepatitis B surface antigen positive on screening
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02766933
|Contact: Norah Nyah, M.D.||email@example.com|
|Principal Investigator:||Norah Nyah, M.D.||Cameroon Baptist Convention Health Board|