The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02766933
Recruitment Status : Active, not recruiting
First Posted : May 10, 2016
Last Update Posted : October 6, 2023
Sponsor:
Collaborator:
Cameroon Baptist Convention Health
Information provided by (Responsible Party):
Lewis R. Roberts, Mayo Clinic

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Hepatitis B Hepatitis B, Chronic

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study
Study Start Date : May 2016
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Proportion of subjects in each phase of chronic hepatitis B infection at enrollment [ Time Frame: 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

  2. yearly incidence of compensated and decompensated cirrhosis in the study cohort [ Time Frame: 5 years ]
    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

  3. yearly incidence of hepatocellular carcinoma in the study cohort [ Time Frame: 5 years ]
    incidence of hepatocellular carcinoma over time in the study cohort as determined by serum alpha fetoprotein, per-protocol imaging studies, and biopsy when appropriate

  4. Percentage of treated subjects who achieve and maintain a complete response to antiviral treatment. [ Time Frame: 5 years ]
    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
Serum and urine at enrollment and follow-up visits

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CBCHB employees and their spouses who are found to be hepatitis B surface antigen positive during screening.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766933


Locations
Layout table for location information
Cameroon
Mbingo Baptist Hospital
Bamenda, Northwest, Cameroon
Sponsors and Collaborators
Mayo Clinic
Cameroon Baptist Convention Health
Investigators
Layout table for investigator information
Principal Investigator: Norah Nyah, M.D. Cameroon Baptist Convention Health Board
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Lewis R. Roberts, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02766933    
Other Study ID Numbers: 16-001716
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: October 6, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lewis R. Roberts, Mayo Clinic:
tenofovir
hepatocellular carcinoma
cirrhosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Chronic Disease
Disease Attributes
Pathologic Processes