Treatment for primary biliary cholangitis
a biliary cholangitis and compound technology, applied in the field of development of therapeutic compounds for the prevention and treatment can solve the problems of additional medical therapy and/or liver transplantation, one out of three patients does not adequately respond, etc., to achieve the effect of preventing the progression of primary biliary cholangitis, rapid onset of ductopenia, and increasing liver fibrosis
- Summary
- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Benefits of technology
Problems solved by technology
Method used
Image
Examples
example 1
of Compound of Formula (Ia) in Carbon Tetrachloride-Induced Liver Fibrosis in Male Sprague Dawley Rats
Purpose
[0104]The objective of this study was to evaluate the efficacy of Compound of formula (Ia) in hepatic fibrosis induced by carbon tetrachloride administration in male Sprague Dawley rats.
Methods
[0105]To assess the effect of Compound of formula (Ia) on the progression of established hepatic fibrosis, fibrosis was induced in rats by twice weekly carbon tetrachloride (CCl4) injections for 2 weeks via an intraperitoneal route. Compound (Ia) (0.4 and 4 mg / kg / day), pioglitazone (10 mg / kg / day), fenofibrate (100 mg / kg / day) or vehicle (Tween 80 and 0.5% sodium salt of carboxymethylcellulose at ratio of 0.5:99.5) was then orally administered for 4 weeks to animals concomitantly with continued CCl4 injections.
[0106]After 4 weeks of treatment, blood samples were collected 1 h post-dose, for estimation of non-fasted serum ALT and other serum parameters. All the animals were sacrificed; liv...
example 2
tic Activity of Compound of Formula (Ia) Will be Evaluated in the Thioacetamide (TAA) Model of Liver Fibrosis in Rats
Purpose
[0109]The objective of this study is to evaluate the efficacy of Compound (Ia) in hepatic fibrosis and induced by thioacetamide (TAA) administration in male Sprague Dawley rats. Secondarily hepatic fibrosis causes increased portal pressure so effect on portal pressure will also be evaluated in this model.
Methods
[0110]To assess the effect of Compound (Ia) on the progression of established hepatic fibrosis, fibrosis will be induced in rats by intraperitoneal TAA injections (50-150 mg / kg) or, and animals will be treated with Compound (Ia) at 4 mg / kg dose or vehicle according to the following study design. First TAA and or test compound will be given simultaneously for a period of 6 weeks and in second design first TAA was administered and for a period of 6 weeks and then week-6 onwards treatment will be initiated at 4 mg / kg dose of Compound (Ia).
[0111]After 6 week...
example 3
, Prospective, Multicenter, Randomized, Open Label, Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar (as its Magnesium Salt) in Patients with Primary Biliary Cholangitis
[0114]Objectives: The purpose of this study is to evaluate the safety tolerability, and efficacy of Saroglitazar (as its Magnesium salt) in patients with Primary Biliary Cholangitis.
Primary Evaluation Criteria:
[0115]To investigate the effect of a 16-week treatment regimen of Saroglitazar (as its Magnesium salt), 4 mg on alkaline phosphatase (ALP) levels in patients with Primary Biliary Cholangitis
Secondary Endpoints
[0116]To compare the effect of Saroglitazar (as its Magnesium salt) compared to Obeticholic Acid for the following parameters following a 16-week treatment regimen:[0117]Alkaline Phosphatase[0118]Pruritus[0119]Lipids profile: TG, TC, HDL, LDL, and VLDL[0120]Liver function test: GGT, ALT, AST, bilirubin and albumin[0121]Quality of life[0122]Safety and tolerability of Saroglitazar Magnesiu...
PUM
| Property | Measurement | Unit |
|---|---|---|
| pH | aaaaa | aaaaa |
| alkaline phosphatase activity | aaaaa | aaaaa |
| weight | aaaaa | aaaaa |
Abstract
Description
Claims
Application Information
Login to View More