Fibrosis, LiverHEPATOCHLORDNCT03373396
Impact of Chlordecone on Active Chronic Hepatitis
A study testing Blood samples in people with Fibrosis, Liver, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrosis, Liver
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 8 Nov 2011to 21 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Guadeloupe1 site
Hospital University Center of Pointe-à-Pitre
Pointe-à-Pitre, 97159
About this study
Official title: Impact of Chlordecone Exposure on Evolution of Fibrosis to Cirrhosis in Chronic Hepatitis C, B or Alcoholic, in Guadeloupe.
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.
Read the 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.
- Conditions
- Fibrosis, Liver
- Being tested
- Blood samples
- Keywords
- Chlordecone, fibrosis, cirrhosis, chronic hepatitis B, C, alcohol, viral hepatitis, transaminases, fibroscan
- Medical subject headings
- Liver Cirrhosis, Fibrosis, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesDiagnostic test
Collected data will contain epidemiological and biological data, blood samples with chlordecone dosage.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 5 years.
Secondary outcomes (1)
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.
Measured: through study completion, an average of 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start8 Nov 2011
- Primary completion21 Dec 2015
- Study completion21 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fibrosis, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moana GELU SIMEON, hepato-gastoenterology, Principal investigator, Hospital University Center of Pointe-à-Pitre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373396
- Sponsor's protocol ID
- RBM-PAP-2011/25
- Acronym
- HEPATOCHLORD
- Status last verified
- Dec 2017
- First submitted
- 4 Dec 2017
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38504260
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chlordecone Exposure on Evolution of Fibrosis to Cirrhosis in Chronic Hepatitis C, B or Alcoholic, in Guadeloupe.
- ClinicalTrials.gov ID
- NCT03373396
- Acronym / sponsor ID
- HEPATOCHLORD / RBM-PAP-2011/25
- Conditions
- Fibrosis, Liver
- Keywords
- Chlordecone, fibrosis, cirrhosis, chronic hepatitis B, C, alcohol, viral hepatitis, transaminases, fibroscan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 8 Nov 2011 (actual)
- Primary completion
- 21 Dec 2015 (actual)
- Study completion
- 21 Dec 2015 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Case group with Metavir score between F1 and F4 | Other | Diagnostic Test: Blood samplesPatient 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. |
| Control group with Metavir score of between F0 | Other | Diagnostic Test: Blood samplesPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesCollected data will contain epidemiological and biological data, blood samples with chlordecone dosage. | Diagnostic test | Case group with Metavir score between F1 and F4, Control group with Metavir score of between F0 |
Primary outcome
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.
1 secondary outcome
Epidemiological study of hepatitis B, C and alcoholic in Guadeloupe
Time frame: through study completion, an average of 5 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
- Derived from this study: PubMed 38504260Gelu-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moana GELU SIMEON, hepato-gastoenterology principal investigator
Hospital University Center of Pointe-à-Pitre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Fibrosis, Liver, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03373396, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2017.