An interventional study of Blood samples in Fibrosis, Liver, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Completed at 1 site in Guadeloupe. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-14.
Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Not applicable, Interventional, and Diagnostic
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.
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.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's enrollment of 283 is above the median of 78 across 739 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: through study completion, an average of 5 years.
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.
Time frame: through study completion, an average of 5 years.
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2011 to primary completion in Dec 2015, 49 months.
Of 207 non-industry interventional studies with no phase under Liver Cirrhosis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 73. This study's 49 months is above that.
Counting every sponsor, half of 216 studies reached it within 32 months; a quarter within 17 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de la Guadeloupe