Impact of Chlordecone on Active Chronic Hepatitis

Fibrosis, Liver Clinical Trial

— HEPATOCHLORD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03373396
• Other study ID #: RBM-PAP-2011/25
• Status: Completed
• Phase: N/A
• First received: December 4, 2017
• Last updated: December 8, 2017
• Start date: November 8, 2011
• Est. completion date: December 21, 2015

Study information

• Verified date: December 2017
• Source: Centre Hospitalier Universitaire de Pointe-a-Pitre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: December 21, 2015
• Est. primary completion date: December 21, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Fibrosis, Liver
• Hepatitis
• Hepatitis, Chronic
• Liver Cirrhosis

Intervention

Diagnostic Test:
• Blood samples
Collected data will contain epidemiological and biological data, blood samples with chlordecone dosage.

Locations

Country	Name	City	State
Guadeloupe	Hospital University Center of Pointe-à-Pitre	Pointe-à-Pitre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Pointe-a-Pitre

Country where clinical trial is conducted

Guadeloupe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.