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Completed

NCT Number: NCT03373396

Impact of Chlordecone on Active Chronic Hepatitis

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.

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Key information

Conditions

Fibrosis, Liver Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Fibrosis Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital University Center of Pointe-à-Pitre

Pointe-à-Pitre, 97159, Guadeloupe

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood samples

Diagnostic Test

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

Primary outcomes

  1. 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.

    Time frame: through study completion, an average of 5 years.

    : 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.

Secondary outcomes

  1. Epidemiological study of hepatitis B, C and alcoholic in Guadeloupe

    Time frame: through study completion, an average of 5 years.

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Guadeloupe

Other

Registry information

Official study title

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

Acronym: HEPATOCHLORD

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 14, 2017
Registry last updated
Dec 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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