Impact of Chlordecone on Active Chronic Hepatitis

NCT03373396 | Completed DMC

• 1 other identifier: RBM-PAP-2011/25
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibrosis, Liver

Keywords

Chlordecone; fibrosis; cirrhosis; chronic hepatitis B, C; alcohol; viral hepatitis; transaminases; fibroscan

Outcome Measures

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.

  : 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 Outcomes (1)

• Epidemiological study of hepatitis B, C and alcoholic in Guadeloupe

  through study completion, an average of 5 years.

Study Arms (2)

Case group with Metavir score between F1 and F4

OTHER

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

Control group with Metavir score of between F0

OTHER

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

Interventions

Blood samples DIAGNOSTIC_TEST

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

Case group with Metavir score between F1 and F4; Control group with Metavir score of between F0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (1)

Hospital University Center of Pointe-à-Pitre

Pointe-à-Pitre, 97159, Guadeloupe

Location

Related Publications (1)

• Gelu-Simeon M, Lafrance MJ, Michineau L, Saillard E, Thome JP, Emond C, Samson M, Multigner L. Inverse association between plasma chlordecone concentrations and progression of alcoholic liver fibrosis: the role of liver metabolism. Environ Health. 2024 Mar 20;23(1):30. doi: 10.1186/s12940-024-01054-6.

  PMID: 38504260 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis; Hepatitis B, Chronic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Moana GELU SIMEON, hepato-gastoenterology

  Hospital University Center of Pointe-à-Pitre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 14, 2017
• Study Start: November 8, 2011
• Primary Completion: December 21, 2015
• Study Completion: December 21, 2015
• Last Updated: December 14, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)