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Hepatitis B, ChronicNCT04886102

Molecular Epidemiology of Hepatitis B in Cayenne General Hospital, French Guiana

An observational study of Hepatitis B, Chronic and Adults, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In South America, the prevalence of HBV is variable but high (> 8%) in the Amazon basin. In some areas, a third of HBsAg carriers are also infected with HDV, a major comorbidity factor. The pre-core mutations are associated with the negative HBe Ag phenotype which is associated with a more severe course. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis B, Chronic, Adults
What is being tested?
An additional 5 mL venous blood tube taken from patients during their routine medical check-up at the hospital
How many people
400 participants
Where
1 siteFrench Guiana
Study dates
11 Feb 2021to 1 Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients infected with hepatitis B followed at the Cayenne hospital center (adult day hospital consultations, consultations with the infectious and tropical diseases department and hepatology B medicine consultations) Estimated size of target population: 1000

Who may be able to join

  • Age ≥ 18 years old
  • Person with confirmed chronic hepatitis B
  • Person who does not object to their participation in the protocol
  • HBV viral load> = 500 copies / mL
  • Person who has planned / is willing to have their next HBV assessment of current care taken at the Cayenne Hospital center

Who cannot join

  • Refusal to participate
  • Age <18 years old
  • Person opposing their participation in the protocol
  • HBV viral load <500 copies / mL
  • Person who has not planned / been unwilling to have their next HBV assessment of current care taken at the Cayenne Hospital center

Trial locations and contacts

1 site in 1 country.

DRISP General Hospital of Cayenne contact

+594 594 39 53 85

cicec@ch-cayenne.fr

French Guiana1 site, 1 recruiting
  • General Hospital of Cayenne

    Cayenne, 97306

    Mathieu Nacher, MD, PhD, +594 594 39 50 24 ext. 5024, mathieu.nacher@ch-cayenne.fr

    Recruiting

Other trials in French Guiana

About this study

In South America, the prevalence of HBV is variable but high (> 8%) in the Amazon basin. In some areas, a third of HBsAg carriers are also infected with HDV, a major comorbidity factor. The pre-core mutations are associated with the negative HBe Ag phenotype which is associated with a more severe course. These mutations are of increasing and high frequency. French Guiana is populated by populations of African, European and Asian origins with chains of viral transmission which are not known and viruses probably of different origins with variable virulence and transmission potentials.

Read the detailed description

Human demography and migrations play a crucial role in the phylogeography of viral populations. Hepatitis B viruses are characterized by a high genetic diversity which results from the fact that this virus uses a reverse transcriptase during its replicative cycle, which induces errors and therefore variation. A dozen genotypes have so far been described and are subdivided into sub-genotypes which have a distinct ethnogeographic distribution. Genotypes A and D are ubiquitous and represent the most common genotypes in Europe; genotypes B and C are very common in Asia and Oceania, genotype E in Central Africa and West Africa, genotypes H and F in Latin America and Alaska, and Genotype I in Southeast Asia. The populations originating from these different continents are all represented in Guyana and it is therefore interesting to understand what are the chains of transmission and the phylodynamic aspects of the epidemic in French Guiana. In addition, the different genotypes have variable clinical consequences, and this in different ways depending on the ethnicity of the host. Thus, in Mexico, the F and H genotypes appear to be rather benign in the Amerindians among whom they have circulated for a long time. On the other hand, genotypes F, A and D are of rather severe evolution in Mexicans of Caucasian origin, thus suggesting that the immunogenetic factors of the host are important determinants of the pathogenic power of the viruses (Roman and al WJG 2014).

Some pre-core mutations leave the virus with the capacity to replicate. The absence of the HBe antigen deprives the immune system of an important target and the virus can therefore continue to replicate. These pre-core mutations are associated with the HBe Ag negative phenotype (7 to 30% of patients) which is associated with a more severe course of chronic hepatitis. These mutations are of increasing and high frequency (Funk ML, and al 2001).

Addiction to crack cocaine is widespread in French Guiana and appears to be one of the drivers of the epidemic. The pipes used to smoke crack cause burns on the lips and when sharing the pipe could contribute to increasing the risk of transmission (Fischer and al 2008). Risky sexual behavior is associated with the use of crack cocaine, suggesting that there may be specific chains of transmission around crack users.

Primary objective Identify the factors associated with different genotypes (age, sex, country of birth, sexual orientation, sexual risk taking, notion of IV drug addiction, crack ...) in order to identify specific chains of transmission in French Guiana.

Secondary objectives

  • Describe the molecular epidemiology of hepatitis B (AgS and pre-core mutations) in French Guiana
  • Carry out the phylodynamic study of the different HBV genotypes in order to reconstruct the history of the epidemic in French Guiana
  • Identify the clinical prognostic factors associated with the different genotypes and phylogenetic aspects in order to identify the viruses with the greatest pathogenic potential in French Guiana
  • Describe the molecular epidemiology of hepatitis D in B-D coinfected in French Guiana

Cross-sectional, monocentric, observational study with biological collection.

Research protocol involving the human person (Category 3 - Non-interventional research_ not related to a health product)

Being tested
An additional 5 mL venous blood tube taken from patients during their routine medical check-up at the hospital
Keywords
Hepatitis B, Chronic, Hepatitis B Virus Infection, Adults, French Guiana, Hepatitis C Virus Infection, Co-infection, Chain of transmission, Epidemiology, molecular, Viral phylodynamics, Viral phylogenetics
Medical subject headings
Hepatitis B, Chronic, Hepatitis B, Hepatitis C, Coinfection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • An additional 5 mL venous blood tube taken from patients during their routine medical check-up at the hospitalOther

    Also called Molecular biology analyzes of hepatitis B and D, Phylogenetic and phylodynamic analyzes of hepatitis B, Phylogenetic and phylodynamic analyzes of hepatitis C

    Research protocol involving the human person (Category 3 - Non-interventional research_ not related to a health product) Serology, molecular biology, phylogenetic and phylodynamic analyzes of hepatitis B and D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hepatitis B virus (HBV) sequencing

    The mutations studied will be those relating to AgS and to the pre-core regions.

    The viral nucleic acids will be extracted using the Qiagen® technique on the Qiacube® machine. The HBV genotyping will be carried out by sequencing the nucleotides of a DNA segment amplified from the HBV S gene (nt 414 to nt 822, reference sequence HBV strain NC003977). In order to study the genetic proximity between the HBV strains, the samples will be subjected to whole genome sequencing based on the method of Ramachandran et al using two amplification steps. The first round of whole genome amplification will be followed by a second round of PCR nested on 6 overlapping fragments of 600bp each.

    A phylodynamic approach will estimate the aspects time of viral evolution. Phylogenetic trees will be produced to illustrate the genetic differences between the different types of viruses circulating in French Guiana with Mega software.

    Measured: 2 years

Secondary outcomes (2)
  1. Hepatitis D virus (VHD) sequencing

    In patients also with HDV infection, HDV genotyping will be performed by nucleotide sequencing and phylogenetic analysis of the amplified R0 regions of the genome (nt 889 to nt 1289). The complete sequences will be characterized by the amplification and sequencing of 4 overlapping regions covering the entire genome: R0 (nt 889 to nt 1289), R1 (nt 320 to nt 1289), R2 (nt 889 to nt 420) and R3 (nt 200 to nt 560).

    A phylodynamic approach will estimate the aspects time of viral evolution. Phylogenetic trees will be produced to illustrate the genetic differences between the different types of viruses circulating in French Guiana with Mega software.

    Measured: 2 years

  2. Liver function Markers

    Various liver function markers will be taken. Several groups will be distinguished and compared in terms of genotype and subclades, thus testing the null hypothesis of an absence of difference between genotypes and markers of evolution. Association will be assessed using Chi square tests for crosstabulation of categorical variables and other genotypes (exploratory analyses).

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2021
  2. Study start11 Feb 2021
  3. Primary completion1 Feb 2022 (estimated)
  4. Study completion1 Feb 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04886102
Sponsor's protocol ID
EMOHCAY
Status last verified
May 2021
First submitted
27 Jan 2021
Last updated
13 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis B, Chronic and Adults, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in French Guiana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Roxane SCHAUB, MD (+594 594 39 55 96, roxane.schaub@ch-cayenne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hepatitis B virus (HBV) sequencing (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.

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