Liver Cirrhosis Clinical Trial
Official title:
Evaluation of Prolonged-release Pirfenidone in Patients With Viral C Hepatitis, With Sustained Viral Response and Advanced Residual Liver Fibrosis. Potential Role of Epigenetics to Understand Therapeutic Changes (MINERVA).
Prolonged-Release Pirfenidone (PR-PFD) is an anti-fibrogenic and anti-inflammatory molecule used for the treatment of idiopathic pulmonary fibrosis (approved by FDA) and liver fibrosis (approved in Mexico by COFEPRIS). PFD effects are mediated in part through inhibition of TGFβ, TNFα, IL-1 and IL-6, along with NFκB activation down-regulation causing reduced TNFα and IFNγ levels. The aim of this protocol is to know if the epigenetic factors induced by PR-PFD have a regulatory role to understand the progression variants in liver fibrosis in a group of patients with viral hepatitis C, with a history of sustained viral response and advanced residual liver fibrosis. To assess the safety and efficacy of two daily doses of pirfenidone (KitosCell® LP), in patients with compensated liver cirrhosis.
Design: Observational clinical study, in an open population, of 12 months duration. Sixty patients with chronic Viral C hepatitis, who have been treated with direct-acting antivirals, with a sustained viral response and who still have advanced fibrosis (F3-F4). Aim: to know if the epigenetic factors induced by PR-PFD have a regulatory role to understand the progression variants in liver fibrosis in a group of patients with viral hepatitis C, with a history of sustained viral response and advanced residual liver fibrosis. To assess the safety and efficacy of two daily doses of pirfenidone (KitosCell® LP), in patients with compensated liver cirrhosis. Dosage: 1200 mg / day of Pirfenidone (KitosCell® LP) Variables to Analyze: Reduction of fibrosis and evaluation of epigenetic changes in the expression of various genes: PPARγ, PPARδ, PPARα, TGFβ1, Col1A1 and PDGFα. Additionally, changes in the expression levels of miR-122, miR192, miR-200a / b, miR-34a, miR-16, miR-21 and miR-181b will be evaluated, as well as changes in the transcriptome in ccfRNA. Ethical considerations: The study will be conducted in accordance with the Declaration of Helsinki and the E6 Good Clinical Practice Standards International Conference on Harmonization (ICH). Statistical Data Analysis: Descriptive statistics will be used and according to analytical statistical requirements that include parametric or non-parametric tests. The value of p <0.05 will be considered as significant. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04533932 -
Endosonographic Shear Wave Elastography for Liver Stiffness
|
||
| Not yet recruiting |
NCT06031740 -
A Comparison of Flexible Endoscopic Polidocanol Liquid and Foam Sclerotherapy in Cirrhotic Patients With Bleeding From Internal Hemorrhoids
|
N/A | |
| Not yet recruiting |
NCT06026267 -
Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis
|
N/A | |
| Not yet recruiting |
NCT06076330 -
Efficacy of 5% Albumin v/s Plasmalyte in Combination With 20% Albumin for Fluid Resuscitation in Cirrhosis With Sepsis Induced Hypotension
|
N/A | |
| Enrolling by invitation |
NCT05055713 -
A Randomized Controlled Study on the Treatment of Cirrhosis Combined With Hypersplenism
|
N/A | |
| Recruiting |
NCT04578301 -
Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
|
||
| Not yet recruiting |
NCT05120557 -
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
|
N/A | |
| Not yet recruiting |
NCT05515861 -
Evaluation of EUS in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices
|
N/A | |
| Not yet recruiting |
NCT02710227 -
Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis
|
N/A | |
| Not yet recruiting |
NCT03623360 -
Functional MRI to Determine Severity of Cirrhosis
|
||
| Completed |
NCT02917408 -
Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
|
||
| Active, not recruiting |
NCT02551250 -
Annual MRI Versus Biannual US for Surveillance of Hepatocellular Carcinoma in Liver Cirrhosis
|
||
| Recruiting |
NCT02239991 -
Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant
|
N/A | |
| Enrolling by invitation |
NCT02256514 -
Open Label Trial of Immunotherapy for Advanced Liver Cancer
|
Phase 2 | |
| Terminated |
NCT02311985 -
Comparison of Three Transfusion Strategies for Central Venous Catheterization in Cirrhotics: A Randomized Clinical Trial
|
N/A | |
| Terminated |
NCT01937130 -
Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF
|
Phase 2 | |
| Recruiting |
NCT01618890 -
Hepatic Venous Pressure Gradient-guided Versus Standard Beta-blocker Therapy in Primary Prevention of Variceal Bleeding
|
Phase 3 | |
| Recruiting |
NCT01728688 -
Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis
|
Phase 1/Phase 2 | |
| Recruiting |
NCT01724697 -
Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis
|
Phase 1/Phase 2 | |
| Recruiting |
NCT01728727 -
Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis
|
Phase 1/Phase 2 |