NCT03362866

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

4.2 years

First QC Date

November 24, 2017

Last Update Submit

September 4, 2018

Conditions

Hepatitis BHepatitis CHepatitis D

Outcome Measures

Primary Outcomes (1)

  • Number of patients with hepatitis B, C and Δ in Reunion

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hepatitis B, C, D patients in Reunion Island

You may qualify if:

  • Major patient
  • with confirmed HBsAg and / or anti HCV positive Ab
  • residing in Reunion Island
  • followed in one of the participating centers

You may not qualify if:

  • Patient carrying isolated anti HBc antibodies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis BHepatitis CHepatitis D

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesFlaviviridae InfectionsRNA Virus Infections

Central Study Contacts

Olivier Maillard, PharmD

CONTACT

+262693025589olmaillard@yahoo.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2017

First Posted

December 5, 2017

Study Start

January 1, 2019

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share