View clinical trials related to Hepatitis, Autoimmune.
Filter by:This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks in subjects with autoimmune hepatitis (AIH) who have liver enzymes that are 1.25 to 10 times the upper limit of normal (ULN) and who have had a failed response to, incomplete response to, intolerant to, ineligible to, or unwilling to take current immunosuppressant therapies. The dose of JKB-122 will be escalated monthly.
The gold-standard treatment of Autoimmune hepatitis (AIH), with prednisone alone or in conjunction with azathioprine can reach resolution of the disease in 70-80% of the cases in US. However, in Brazil the response to these treatments seems to be worse, approximately 35% in five years. Because of the side effects of the gold-standard treatment and the need for an alternative option for the no responsive patients, news drugs must be evaluated for this proposal. Chloroquine diphosphate is an antimalarial drug that has been used for the treatment of rheumatological diseases for at the least five decades. Chloroquine was used as a single drug for up to two years for the maintenance of AIH remission in an open study. There was a 6.49 greater chance of relapse in the historical controls when compared with patients treated with chloroquine (72.2% x 23.5%; p = 0.031). The aim of this study was to investigate whether chloroquine in conjunction with prednisone can be used as an alternative treatment of AIH in a randomized study, and to evaluate its side effects.
The purpose of this study is to study the safety and tolerability of synthetic PreImplantation Factor (sPIF) in female patients with autoimmune hepatitis. Autoimmune hepatitis is a disease where the patient's immune system produces an inappropriate immune response against their own liver. PreImplantation Factor is a substance that is secreted by viable fetuses during pregnancy. PIF apparently initiates both maternal tolerance preventing the loss/rejection of the fetus. Synthetic PIF (sPIF) successfully translates PIF endogenous properties to pregnant and non-pregnant immune disorders. sPIF was found to be effective in preclinical models of autoimmunity and transplantation (published). Specifically sPIF protected the liver against immune attack. Toxicity studies (mice, dogs) have shown that high-dose sPIF administration for 2 weeks followed by 2 weeks observation period demonstrated a high safety profile. This study will evaluate the safety, tolerability and the blood level of this synthetic version of this natural compound in the circulation.
The purpose of this study is to provide insights into the cause, development and effects of de novo autoimmune hepatitis so that prevention and treatment strategies can be developed in order to reduce post-liver transplant morbidity, the frequency of liver allograft loss and the need for re-transplantation.
The purpose of this study is to determine whether a salt restriction diet improves immune parameters in patients with autoimmune hepatitis.
TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a set of 14 autoimmune and auto-inflammatory diseases, with the aim to select diseases in which further therapeutic development will be performed. Extensive biological- and immune-monitoring pre- and post-IL2 will contribute (i) to define the common or distinct processes responsible for the breakdown of immunological tolerance in these pathologies and (ii) to discover potential biomarkers of the IL2 response.
Autoimmune hepatitis is an autoimmune chronic liver disease whose treatment includes the use of immunosuppressive drugs, particularly azathioprine, and corticosteroids. When properly treated, patients have a good survival. One of the major problems related to its treatment is the the high rate of relapses after stopping therapy that has lead to biochemical and histological remissions, close to 80%. Many authors recommend continuous treatment throughout life, resulting in the occurrence of many side effects. Chloroquine is a drug with anti-inflammatory properties already used in the treatment of other extrahepatic autoimmune liver diseases. There are some reports in the literature about its beneficial use in liver diseases such as chronic hepatitis B, and a pilot study in patients with autoimmune hepatitis, in which its use was associated with a 6.49 times lower risk of disease recurrence when compared with patients in whom treatment was discontinued after remission. Our purpose is to investigate, in a double-blind randomized trial with placebo, whether chloroquine prevents the recurrence of AIH in patients with histological remission after discontinuation of conventional treatment and to evaluate the occurrence of side effects.
Recent, research has focused on the evaluation of non-invasive methods for the assessment of liver fibrosis in patients with chronic liver disease. Among these methods, transient elastography is the most promising. The method has been investigated mainly in patients with viral hepatitis. Several studies have shown, that the optimal cut-off value of TE for detection of liver cirrhosis by transient elastography is highly dependent on the aetiology of the underlying liver disease. Only a few studies have evaluated the value of transient elastography for patients with autoimmune liver disease and here primarily patients with PBC and PSC. For patients with autoimmune hepatitis the data is limited. We prospectively investigated the diagnostic accuracy of TE in autoimmune hepatitis compared to liver histology with and without inclusion of the macroscopic appearance using mini-laparoscopy
Autoimmune hepatitis (AIH) is characterized by chronic inflammation of the liver, interface hepatitis, hypergammaglobulinemia, and the presence of autoantibodies. Disease presentation is varied but typically is based on characteristic aminotransferase elevations, histological abnormalities, elevated levels of serum globulins, and the presence of one or more autoantibodies. Two types of juvenile AIH have been identified according to seropositivity for smooth muscle and /or antinuclear antibody (AIH type 1) or liver kidney microsomal antibody (AIH type 2). Standard therapy in clinic consists of a combination of corticosteroids and azathioprine, which displays the efficacy in 80% of patients. However, 7% of patients deteriorate despite compliance with the standard corticosteroid regiments (treatment failure),13% of patients improve but not to a degree that satisfies remission criteria (incomplete response), 13% of patients develop serious drug-induced complications, and 50%-86% of patients will relapse after drug withdrawal. These serious drawbacks counterbalance the benefits of conventional therapy, and they are compelling reasons to refine current treatment strategies and pursue alternative therapies. UC-MSC has been the application for the treatment of several severe autoimmune diseases, such as immune thrombocytopenia, systemic lupus erythematosus, and therapy-resistant rheumatoid arthritis. In this study, the safety and efficacy of UC-MSC transplantation for AIH patients will be evaluated.
Autoimmune hepatitis is a chronic disease of the liver caused by an alteration of the immune response that attacks the body's own hepatocytes, progressively, leading to cirrhosis and liver failure. There are few studies on dietary management in hepatitis and most of theme have focused on micronutrients specifically vitamin D to prevent osteoporosis, and decreased symptoms of other diseases associated, but few recommendations have been made regarding a complete dietary approach. Fiber has been proven to increase the excretion of nitrogen products and consequently reduce its blood levels and an adequate protein intake (1.2g/kg) has shown to decrease endogenous catabolism in cirrhotics patients. The implementation of a high protein high fiber nutrition plan and improves nutritional status of patients with autoimmune cirrhosis.