Identification of Biomarkers Related to Liver Fibrosis as New Therapeutic

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

The study will be performed in 30 patients. Patients will be enrolled in two investigators sites (Cochin Hospital, Pitie-Salpetriere Hospital, France) where the patient selection will be conducted during a Multidisciplinary Collaborative Meeting. The patients will be enrolled after collecting their informed consent. As soon as the patient is included, arrangements will be made for the organization of the liver resection according to the usual procedure of the hospital department. The biological samples for the research (blood and liver) will be taken at the time of the surgery and sent to the Research Unit (Institut Pasteur) where immunological analyses will be carried out. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03979417
Study type	Observational
Source	Institut Pasteur
Contact
Status	Completed
Phase
Start date	September 30, 2019
Completion date	October 26, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05570058` - Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis	Phase 2
Completed	`NCT02408744` - Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease	Phase 1/Phase 2
Active, not recruiting	`NCT00148837` - Efficacy of Prazosin Versus Placebo Associated With Peg-Interferon Alpha 2b and Ribavirin in Chronic Hepatitis C With Genotype 1 or 4 and Severe Fibrosis	Phase 2
Recruiting	`NCT05661123` - Effect of Modified Complete Decongestive Therapy on Lower Limbs Fibrosis Post Cellulitis	N/A
Recruiting	`NCT04795570` - Urethral Stricture After Transurethral Resection of the Prostate/Bladder: a Prospective Study of Risk Factors
Active, not recruiting	`NCT05075785` - Covid-19 Respiratory Sequelae French Cohort
Recruiting	`NCT03308916` - Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers	N/A
Recruiting	`NCT05459259` - Physiotherapy for Arthrofibrosis Following Knee Replacement.
Enrolling by invitation	`NCT01483248` - Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis	Phase 1/Phase 2
Completed	`NCT00001729` - Combination Drug Therapy for Patients With Hepatitis C	Phase 3
Completed	`NCT02049307` - Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial	Phase 2
Active, not recruiting	`NCT05685823` - The Impact of Conventional Hemodialysis and Renal Transplantation on the Global Longitudinal Strain of the Left Ventricle
Completed	`NCT00744939` - Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist	Phase 4
Completed	`NCT00252642` - Peginterferon Alpha-2a Maintenance Therapy for Portal Hypertension in Patients With Hepatitis C	N/A
Recruiting	`NCT04934202` - Cohort Follow-up of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic in France
Completed	`NCT02774161` - B-mode Ultrasound Imaging in Detecting Early Liver Cancer	N/A
Completed	`NCT02604862` - Imaging FIB ONE in the Human Lung Using Endomicroscopy	Early Phase 1
Active, not recruiting	`NCT01246388` - Non-Invasive Evaluation of Fibrosis and Steatosis in Chronic Hepatopathy	N/A
Completed	`NCT00347009` - Adefovir Dipivoxil For The Treatment Of Patients With Chronic Hepatitis B Related Advanced Fibrosis Or Cirrhosis	Phase 4
Completed	`NCT02161952` - Pirfenidone, an Antifibrotic and Antiinflammatory Drug	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Identification of Biomarkers Related to Liver Fibrosis as New Therapeutic Targets — FIBROTHER

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms