- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03362866
Epidemiology of Hepatitis B, C and Delta in Reunion Island (HEPEPID)
September 4, 2018 updated by: Centre Hospitalier Universitaire de la Réunion
Viral hepatitis B, C and Δ represent a global public health problem for which France was very early mobilized.
Despite this, in its foreword, the Dhumeaux report on "Management of people infected with hepatitis B or hepatitis C viruses" identifies a residual area of weakness in this care that is the incomplete regional epidemiological data in the Overseas Territories.
The specific ethno-socio-cultural characteristics of these territories make it difficult to transpose data from the mainland France.
This study aims at improving our knowledge on the characteristics of patients with hepatitis B, C and Δ in Reunion Island, their follow-up, their evolution and complications.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
2000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Hepatitis B, C, D patients in Reunion Island
Description
Inclusion Criteria:
Major patient
- with confirmed HBsAg and / or anti HCV positive Ab
- residing in Reunion Island
- followed in one of the participating centers
Exclusion Criteria:
• Patient carrying isolated anti HBc antibodies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with hepatitis B, C and Δ in Reunion
Time Frame: Up to 5 years
|
Hepatitis diagnosis will be made according to the ongoing guidelines in France (referred by the National AIDS and Hepatitis Research Agency (ANRS)
|
Up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
January 1, 2019
Primary Completion (ANTICIPATED)
April 1, 2023
Study Completion (ANTICIPATED)
April 1, 2023
Study Registration Dates
First Submitted
November 24, 2017
First Submitted That Met QC Criteria
November 29, 2017
First Posted (ACTUAL)
December 5, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 5, 2018
Last Update Submitted That Met QC Criteria
September 4, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis D
Other Study ID Numbers
- 2016/CHU/14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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