Clinical trial NCT03373396: Impact of Chlordecone on Active Chronic Hepatitis
Official title: Impact of Chlordecone Exposure on Evolution of Fibrosis to Cirrhosis in Chronic Hepatitis C, B or Alcoholic, in Guadeloupe.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibrosis, Liver
Keywords: Chlordecone
fibrosis
cirrhosis
chronic hepatitis B, C
alcohol
viral hepatitis
transaminases
fibroscan
Lead sponsor: Centre Hospitalier Universitaire de la Guadeloupe
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 283
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: through study completion, an average of 5 years.
Secondary outcomes:
measure: Epidemiological study of hepatitis B, C and alcoholic in Guadeloupe
timeFrame: through study completion, an average of 5 years.
Other outcomes:
Locations:
city: Pointe-à-Pitre
country: Guadeloupe
facility: Hospital University Center of Pointe-à-Pitre
Study officials:
affiliation: Hospital University Center of Pointe-à-Pitre
name: Moana GELU SIMEON, hepato-gastoenterology
role: PRINCIPAL_INVESTIGATOR
References: