Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis
Summary
prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis (PBC). A total 36 subjects will be enrolled in a ratio of 1:1:1 to receive either saroglitazar magnesium 2 mg or saroglitazar magnesium 4 mg or placebo.
Timeline
- Start
- 2017-08-18
- Primary completion
- 2020-08-07
- Completion
- 2020-08-07
Outcome
Met primary endpoint
registry analysis (superiority test); Saroglitazar Magnesium 2 mg vs Placebo; p = 0.0001; paired t-test NCT03112681 ↗
registry MEAN Saroglitazar Magnesium 4 mg: -162.31 (Standard Deviation 113.98) U/L MEAN Placebo: -11.15 (Standard Deviation 27.36) U/L NCT03112681 ↗
registry analysis (superiority test); Saroglitazar Magnesium 4 mg vs Placebo; p = 0.0002; paired t-test NCT03112681 ↗
Publications
- Background European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67. doi: 10.1016/j.jhep.2009.04.009. Epub 2009 Jun 6. No abstract available.
- Background Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906. No abstract available.
- Results Vuppalanchi R, Caldwell SH, Pyrsopoulos N, deLemos AS, Rossi S, Levy C, Goldberg DS, Mena EA, Sheikh A, Ravinuthala R, Shaikh F, Bainbridge JD, Parmar DV, Chalasani NP. Proof-of-concept study to evaluate the safety and efficacy of saroglitazar in patients with primary biliary cholangitis. J Hepatol. 2022 Jan;76(1):75-85. doi: 10.1016/j.jhep.2021.08.025. Epub 2021 Sep 4.
- Vuppalanchi R, Gonzalez-Huezo MS, Payan-Olivas R, Munoz-Espinosa LE, Shaikh F, Pio Cruz-Lopez JL, Parmar D. A Multicenter, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Saroglitazar in Patients With Primary Biliary Cholangitis. Clin Transl Gastroenterol. 2021 Mar 26;12(4):e00327. doi: 10.14309/ctg.0000000000000327.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Saroglitazar | Small molecule | 2 mg | — |
| Subject | Saroglitazar | Small molecule | 4 mg | — |