Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study

NCT02766933 | Completed

• 1 other identifier: 16-001716
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B; Hepatitis B, Chronic

Keywords

tenofovir; hepatocellular carcinoma; cirrhosis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

hepatitis B cohort

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CBCHB employees and their spouses who are found to be hepatitis B surface antigen positive during screening.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Mayo Clinic: lead
• Cameroon Baptist Convention Health: collaborator

Study Sites (1)

Mbingo Baptist Hospital

Bamenda, Northwest, Cameroon

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and urine at enrollment and follow-up visits

MeSH Terms

Conditions

Hepatitis B; Hepatitis B, Chronic; Carcinoma, Hepatocellular; Fibrosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Norah Nyah, M.D.

  Cameroon Baptist Convention Health Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: May 10, 2016
• Study Start: May 1, 2016
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)