Impact of Chlordecone on Active Chronic Hepatitis (HEPATOCHLORD)
Primary Purpose
Fibrosis, Liver
Status
Completed
Phase
Not Applicable
Locations
Guadeloupe
Study Type
Interventional
Intervention
Blood samples
Sponsored by
About this trial
This is an interventional diagnostic trial for Fibrosis, Liver focused on measuring Chlordecone, fibrosis, cirrhosis, chronic hepatitis B, C, alcohol, viral hepatitis, transaminases, fibroscan
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
Sites / Locations
- Hospital University Center of Pointe-à-Pitre
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Case group with Metavir score between F1 and F4
Control group with Metavir score of between F0
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03373396
First Posted
December 4, 2017
Last Updated
December 8, 2017
Sponsor
Centre Hospitalier Universitaire de Pointe-a-Pitre
1. Study Identification
Unique Protocol Identification Number
NCT03373396
Brief Title
Impact of Chlordecone on Active Chronic Hepatitis
Acronym
HEPATOCHLORD
Official Title
Impact of Chlordecone Exposure on Evolution of Fibrosis to Cirrhosis in Chronic Hepatitis C, B or Alcoholic, in Guadeloupe.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 8, 2011 (Actual)
Primary Completion Date
December 21, 2015 (Actual)
Study Completion Date
December 21, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Pointe-a-Pitre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrosis, Liver
Keywords
Chlordecone, fibrosis, cirrhosis, chronic hepatitis B, C, alcohol, viral hepatitis, transaminases, fibroscan
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
283 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Case group with Metavir score between F1 and F4
Arm Type
Other
Arm 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.
Arm Title
Control group with Metavir score of between F0
Arm Type
Other
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood samples
Intervention Description
Collected data will contain epidemiological and biological data, blood samples with chlordecone dosage.
Primary Outcome Measure Information:
Title
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.
Description
: 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.
Time Frame
through study completion, an average of 5 years.
Secondary Outcome Measure Information:
Title
Epidemiological study of hepatitis B, C and alcoholic in Guadeloupe
Description
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.
Time Frame
through study completion, an average of 5 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moana GELU SIMEON, hepato-gastoenterology
Organizational Affiliation
Hospital University Center of Pointe-à-Pitre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital University Center of Pointe-à-Pitre
City
Pointe-à-Pitre
ZIP/Postal Code
97159
Country
Guadeloupe
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Chlordecone on Active Chronic Hepatitis
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