Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study

Hepatitis B Clinical Trial

Official title:

Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02766933
• Other study ID #: 16-001716
• Status: Active, not recruiting
• Start date: May 2016
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Locations

Country	Name	City	State
Cameroon	Mbingo Baptist Hospital	Bamenda	Northwest

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Cameroon Baptist Convention Health

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Enrollment
Primary	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	5 years
Primary	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	5 years
Primary	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	5 years

External Links

•   Mayo Clinic Clinical Trials