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Phase 4 clinical trial study aims to further evaluate the safety and therapeutic efficacy of Resmetirom in Pakistani patients with fibroscan proven MASH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MASH targeted therapy | Experimental | MASH fibrosis stage 2 or 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resmetirom | Drug | 1st FDA approved MASH therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| FIB-4 and CAP score/LSM on fibroscan | Changes in liver fibrosis using non invasive markers | 6 months |
| Changes in thyroid profile | thyroid profile of each patient at baseline and at primary end point | 6 months |
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Inclusion Criteria:
• At least one metabolic comorbidity (e.g., T2DM, obesity, dyslipidemia and hypertension)
Clinical diagnosis of MASH using:
Exclusion Criteria:
• History of drug addiction and alcoholism
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hussain B Abidi, MBBS, MBA, CRCP | Contact | +923322583236 | MDR.hussainabidi@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver transplant center, Holy family hospital | Recruiting | Rawalpindi | Punjab Province | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39735033 | Background | Patel RH, Parikh C, Upadhyay H, Sonaiya S, Ramnath P, Singh S, Patel U, Kothari T. Resmetirom in the Management of Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Comprehensive Review of Current Evidence and Therapeutic Potential. Cureus. 2024 Nov 29;16(11):e74772. doi: 10.7759/cureus.74772. eCollection 2024 Nov. | |
| 34329774 |
| Label | URL |
|---|---|
| Related Info | View source |
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Its undecided for now will be updated laterwards
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| ID | Term |
|---|---|
| C588408 | resmetirom |
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| Younossi ZM, Stepanova M, Taub RA, Barbone JM, Harrison SA. Hepatic Fat Reduction Due to Resmetirom in Patients With Nonalcoholic Steatohepatitis Is Associated With Improvement of Quality of Life. Clin Gastroenterol Hepatol. 2022 Jun;20(6):1354-1361.e7. doi: 10.1016/j.cgh.2021.07.039. Epub 2021 Jul 27. |
| 31727409 | Background | Harrison SA, Bashir MR, Guy CD, Zhou R, Moylan CA, Frias JP, Alkhouri N, Bansal MB, Baum S, Neuschwander-Tetri BA, Taub R, Moussa SE. Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2019 Nov 30;394(10213):2012-2024. doi: 10.1016/S0140-6736(19)32517-6. Epub 2019 Nov 11. |
| 38324483 | Result | Harrison SA, Bedossa P, Guy CD, Schattenberg JM, Loomba R, Taub R, Labriola D, Moussa SE, Neff GW, Rinella ME, Anstee QM, Abdelmalek MF, Younossi Z, Baum SJ, Francque S, Charlton MR, Newsome PN, Lanthier N, Schiefke I, Mangia A, Pericas JM, Patil R, Sanyal AJ, Noureddin M, Bansal MB, Alkhouri N, Castera L, Rudraraju M, Ratziu V; MAESTRO-NASH Investigators. A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis. N Engl J Med. 2024 Feb 8;390(6):497-509. doi: 10.1056/NEJMoa2309000. |