Impact of Chlordecone on Active Chronic Hepatitis (HEPATOCHLORD)

Centre Hospitalier Universitaire de Pointe-a-Pitre

Status: Completed

Conditions: Fibrosis, Liver

Treatments: Diagnostic Test: Blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT03373396

RBM-PAP-2011/25

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 283 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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283 participants in 2 patient groups

Case group with Metavir score between F1 and F4

Other group

Description:

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.

Treatment:

Diagnostic Test: Blood samples

Control group with Metavir score of between F0

Other group

Description:

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.

Treatment:

Diagnostic Test: Blood samples