Fibrosis Clinical Trial
— FIBROTHEROfficial title:
Identification of Biomarkers Related to Liver Fibrosis as New Therapeutic Targets
Verified date | March 2022 |
Source | Institut Pasteur |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Fibrosis is a dynamic process resulting from the balance of fibrogenesis and fibrolysis, mainly secondary to chronic necro-inflammation related to regular alcohol consumption, metabolic syndrome (NASH) or viral hepatitis. The liver has the property of allowing the reversion of fibrosis / cirrhosis when the necrotic-inflammatory activity is controlled. The balance between fibrosis / fibrolysis and its inhibition depends on many pathways and the hypothesis of the efficacy of a single treatment remains uncertain. Molecular factors in the progression of liver fibrosis should be determined. It is necessary to control the liver fibrosis and thus reduce the risk of carcinoma in this population. The anti-fibrotic drugs are being developed, but so far only alpha-tocopherol and obeticholic acid have been shown to have a significant anti-fibrotic effect in humans. Several new drugs are currently being evaluated in ongoing Phase 2 and 3 randomized clinical trials, but most of them have intrinsic limitations: (i) they take a long time for evaluation (> 3 years), ( ii) they generally require an histopathological evaluation by serial liver biopsies that are invasive and unpopular with patients who are aware of noninvasive tests for fibrosis assessment and (iii) treatment is often a single treatment versus a placebo group with the uncertainty that at 1 or 3 years, serial liver biopsies results are convincing.
Status | Completed |
Enrollment | 14 |
Est. completion date | October 26, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients > 18 years - Patients with primary liver disease or liver metastases - Patients undergoing liver resection Exclusion Criteria: - Presence of Human Immunodeficiency Virus (HIV) infection - Presence of Human T Leukemia Virus (HTLV) infection - Taking immunosuppressive drugs in the 6 months prior to surgery - A person deprived of liberty by judicial or administrative decision |
Country | Name | City | State |
---|---|---|---|
France | Cochin Hospital | Paris | |
France | Pitie-Salpetriere Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Institut Pasteur |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of biomarkers of liver fibrosis | Frequency of cell receptors (CD4, CD8, NK, MAIT, etc.) in whole blood and liver (measured by FACS). A comparison will be made in each of the 3 groups (F0-F1, F2-F3, F4) and between the three groups. | Baseline | |
Secondary | Transcription factors | Frequency of transcription factors (Stat1, Stat3, Foxp3, etc.) in whole blood and liver (measured by FACS). A comparison will be made in each of the 3 groups (F0-F1, F2-F3, F4) and between the three groups. | Baseline | |
Secondary | Evaluation of anti-fibrotic properties of biomarkers | Monitoring the properties by different techniques (ELISA, Nanostring, Immunoblotting). A comparison will be made in each of the 3 groups (F0-F1, F2-F3, F4) and between the three groups. | Baseline |
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