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Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Mayo Clinic
Sponsor:
Collaborator:
Cameroon Baptist Convention Health
Information provided by (Responsible Party):
Mark Topazian, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02766933
First received: April 20, 2016
Last updated: November 7, 2016
Last verified: November 2016
  Purpose
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
Hepatitis B
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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
Serum and urine at enrollment and follow-up visits

Estimated Enrollment: 500
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)
Groups/Cohorts
hepatitis B cohort
CBCHB employees and/or spouses found to be hepatitis B surface antigen positive on screening

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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:

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02766933

Contacts
Contact: Norah Nyah, M.D. norah_ndi@yahoo.com

Locations
Cameroon
Mbingo Baptist Hospital Recruiting
Bamenda, Northwest, Cameroon
Contact: Pius Ntomakeh       puisnto@gmail.com   
Contact: Norah Nyah, M.D.       norah_ndi@yahoo.com   
Sponsors and Collaborators
Mayo Clinic
Cameroon Baptist Convention Health
Investigators
Principal Investigator: Norah Nyah, M.D. Cameroon Baptist Convention Health Board
  More Information

Responsible Party: Mark Topazian, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02766933     History of Changes
Other Study ID Numbers: 16-001716 
Study First Received: April 20, 2016
Last Updated: November 7, 2016
Health Authority: United States: Institutional Review Board
Cameroon: Mbingo Baptist Hospital Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Mayo Clinic:
tenofovir
hepatocellular carcinoma
cirrhosis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on December 07, 2016