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Impact of Chlordecone on Active Chronic Hepatitis

NCT ID: NCT03373396

Last Updated: 2017-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

283 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-08

Study Completion Date

2015-12-21

Brief Summary

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Chlordecone is known to induce liver damage in rat and mice but no data exists in human being. However chlordecone was used until 1993 in French West Indies for banana fields, it is important to test what damage can be induced now, for patients exposed. We should consider chlordecone as a potential cofactor of liver fibrosis. So we have chosen to compare two populations of chronic hepatitis B, C or alcoholic, with cirrhosis or without fibrosis due to active hepatitis, who had been exposed to chlordecone.

Detailed Description

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Actually, there is no data concerning the impact of chlordecone on the evolution of fibrosis to cirrhosis in chronic hepatitis whereas many studies have been reported liver damage in mice. The goal of this study is to know if co-exposition to chlordecone can induce evolution to cirrhosis in chronic hepatitis due to alcohol or viral hepatitis. At first, we will assess a group of patients with chronic hepatitis B, C or due to alcohol without fibrosis. And they will be compared to patients with cirrhosis exposed to chlordecone too. Patients will be included in 2 hospital centers. All these patients should have an active liver disease. The activity will be defined by histology or elevated transaminases (\>2N), fibrosis will be defined by histology or an association of fibroscan and biological markers. Exposition to chlordecone will be evaluated by a blood chlordecone measure for every patient.

Conditions

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Fibrosis, Liver

Keywords

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Chlordecone fibrosis cirrhosis chronic hepatitis B, C alcohol viral hepatitis transaminases fibroscan

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

It is a case-control study. There will be two groups. The patient will be assigned to a group according to the Metavir classification. F0 patients will be in the control group.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Case group with Metavir score between F1 and F4

Patient with Metavir score between F1 and F4 will be assigned to the case group. Collected data will contain epidemiological and biological data, blood samples with chlordecone dosage.

Group Type OTHER

Blood samples

Intervention Type DIAGNOSTIC_TEST

Collected data will contain epidemiological and biological data, blood samples with chlordecone dosage.

Control group with Metavir score of between F0

Patient with Metavir score of F0 will be assigned to the control group. Collected data will contain epidemiological and biological data. Blood samples with chlordecone dosage will be performed.

Group Type OTHER

Blood samples

Intervention Type DIAGNOSTIC_TEST

Collected data will contain epidemiological and biological data, blood samples with chlordecone dosage.

Interventions

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Blood samples

Collected data will contain epidemiological and biological data, blood samples with chlordecone dosage.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age above 18 years
* Active chronic hepatitis B or C or alcoholic
* Patient without previous antiviral therapy, activity confirmed by histology or elevated transaminases
* Alcohol consumption more than 20g/d for women and 30g/d for men responsible of chronic alcoholic disease
* Seronegative HIV status, inform consent signed, health insurance

Exclusion Criteria

* Inactive chronic hepatitis
* Other chronic hepatitis as auto-immune hepatitis, hemochromatosis, wilson disease, acute hepatitis due to medication, transplantation, antiviral or imunosupressive treatment, psychiatric disease
* Co-infection with HIV, HBV or HCV
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de la Guadeloupe

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moana GELU SIMEON, hepato-gastoenterology

Role: PRINCIPAL_INVESTIGATOR

Hospital University Center of Pointe-à-Pitre

Locations

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Hospital University Center of Pointe-à-Pitre

Pointe-à-Pitre, , Guadeloupe

Site Status

Countries

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Guadeloupe

References

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Gelu-Simeon M, Lafrance MJ, Michineau L, Saillard E, Thome JP, Emond C, Samson M, Multigner L. Inverse association between plasma chlordecone concentrations and progression of alcoholic liver fibrosis: the role of liver metabolism. Environ Health. 2024 Mar 20;23(1):30. doi: 10.1186/s12940-024-01054-6.

Reference Type DERIVED
PMID: 38504260 (View on PubMed)

Other Identifiers

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RBM-PAP-2011/25

Identifier Type: -

Identifier Source: org_study_id