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Impact of Chlordecone on Active Chronic Hepatitis (HEPATOCHLORD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03373396
Recruitment Status : Completed
First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Pointe-a-Pitre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fibrosis, Liver Diagnostic Test: Blood samples Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 283 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of Chlordecone Exposure on Evolution of Fibrosis to Cirrhosis in Chronic Hepatitis C, B or Alcoholic, in Guadeloupe.
Actual Study Start Date : November 8, 2011
Actual Primary Completion Date : December 21, 2015
Actual Study Completion Date : December 21, 2015

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Arms and Interventions
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Arm Intervention/treatment
Case group with Metavir score between F1 and F4
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
Collected data will contain epidemiological and biological data, blood samples with chlordecone dosage.
Control group with Metavir score of between F0
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
Collected data will contain epidemiological and biological data, blood samples with chlordecone dosage.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373396


Locations
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Guadeloupe
Hospital University Center of Pointe-à-Pitre
Pointe-à-Pitre, Guadeloupe, 97159
Sponsors and Collaborators
Centre Hospitalier Universitaire de Pointe-a-Pitre
Investigators
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Principal Investigator: Moana GELU SIMEON, hepato-gastoenterology Hospital University Center of Pointe-à-Pitre
More Information
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Responsible Party: Centre Hospitalier Universitaire de Pointe-a-Pitre
ClinicalTrials.gov Identifier: NCT03373396    
Other Study ID Numbers: RBM-PAP-2011/25
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Pointe-a-Pitre:
Chlordecone
fibrosis
cirrhosis
chronic hepatitis B, C
 alcohol
viral hepatitis
transaminases
fibroscan
Additional relevant MeSH terms:
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Hepatitis
Hepatitis, Chronic
Liver Cirrhosis
Fibrosis
 Liver Diseases
Digestive System Diseases
Pathologic Processes