ClinicalTrials.gg
Status unknownNCT03362866HEPEPIDUpdated Sep 5, 2018

Epidemiology of Hepatitis B, C and Delta in Reunion Island

An observational study in Hepatitis B, Hepatitis C and Hepatitis D, sponsored by Centre Hospitalier Universitaire de la Réunion. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Observational

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatitis B
  • Hepatitis C
  • Hepatitis D
03

In context

Hepatitis B

1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 365 across 251 observational studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Hepatitis B, C, D patients in Reunion Island

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Major patient

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

Exclusion criteria

Exclusion Criteria:

  • Patient carrying isolated anti HBc antibodies
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
06

What researchers measure

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)

    Time frame: Up to 5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2019; primary completion for Apr 2023, 51 months later.

Of 69 non-industry observational studies under Hepatitis B, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 126. This study's planned 51 months is below that.

Counting every sponsor, half of 81 studies reached it within 55 months; a quarter within 17 and three quarters within 126.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 24, 2017
First posted
Dec 5, 2017
StartEst.
Jan 2019
Primary completionEst.
Apr 2023
CompletionEst.
Apr 2023
Last update
Sep 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03362866
Responsible party
Sponsor
First posted
Dec 5, 2017
Start date
Jan 2019 (estimated)
Primary completion
Apr 2023 (estimated)
Completion
Apr 2023 (estimated)
Last update
Sep 5, 2018

Study contacts

Olivier Maillard, PharmD
Contact
olmaillard@yahoo.fr
+262693025589

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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