Impact of Chlordecone on Active Chronic Hepatitis

Study Overview
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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.

Official Title
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Impact of Chlordecone Exposure on Evolution of Fibrosis to Cirrhosis in Chronic Hepatitis C, B or Alcoholic, in Guadeloupe.

Conditions
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Fibrosis, Liver

Intervention / Treatment
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* Diagnostic Test: Blood samples


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Case group with Metavir score between F1 and F4<br>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. | Diagnostic Test: Blood samples<br>* Collected data will contain epidemiological and biological data, blood samples with chlordecone dosage.<br>|
| Other: Control group with Metavir score of between F0<br>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. | Diagnostic Test: Blood samples<br>* Collected data will contain epidemiological and biological data, blood samples with chlordecone dosage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of progression to cirrhosis with a correlation test between chlordecone exposure and fibrosis in active and chronic hepatitis due to virus B, C or alcohol. | : Chlordecone level will be compared among the two groups (patients with or without significant fibrosis) in order to determine the impact of chlordecone on the evolution of fibrosis. Patients of each group will be paired according to the age, sex, origin of the liver disease. Analysis will be performed using SPSS software. | through study completion, an average of 5 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiological study of hepatitis B, C and alcoholic in Guadeloupe | Distribution of the main etiologies of chronic hepatitis according to age, sex and origin and severity of the liver disease for patients of each group will be performed. | through study completion, an average of 5 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chlordecone, fibrosis, cirrhosis, chronic hepatitis B, C, alcohol, viral hepatitis, transaminases, fibroscan