Global Department CTA Block
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Non-Alcoholic Fatty Liver Disease (NAFLD/NASH)
Bristol-Myers Squibb Company - IM025017
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple-dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults with Compensated Cirrhosis from Nonalcoholic Steatohepatitis (NASH)
- Disease: NASH with Compensated Cirrhosis
- Status: Open Enrollment
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Vela Karakeshishyan, RN-BSN, FMD
- Contact: 305-243-4829 / vxk159@miami.edu
Gilead Sciences, Inc. - GS-US-454-6075
A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects with Compensated Cirrhosis (F4) due to Nonalcoholic Steatohepatitis (NASH)
- Disease: NASH cirrhosis
- Status: Open Enrollment
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Maria Lourdes Olson, FMD
- Contact: 305-243-6939 / malourdeso@med.miami.edu
Hanmi - HM-TRIA-201
Clinical Development HM15211 Clinical Study Protocol HM-TRIA-201 A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH
- Disease: NASH
- Status: Open Enrollment
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Edisson J Aguilera Herrera, FMD
- Contact: 305-243-4648 / eja103@med.miami.edu
Hepion Pharmaceuticals, Inc. - CRV-431-207
A Phase 2B, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CRV431 in Adult Subjects with Nonalcoholic Steatohepatitis and Advanced Liver Fibrosis
- Disease: NASH
- Status: Open Enrollment
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Katheryn Dae, FMD
- Contact: 305-243-1104 / kqd1@med.miami.edu
Inventiva S.A. - 337HNAS20011 (NATiV3)
A randomised, double-blind, placebo- controlled, multicentre, Phase 3 study evaluating long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis
- Disease: NASH
- Status: Open Enrollment
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Kenia Moreno, RN
- Contact: 305-243-9465 / kmoreno@med.miami.edu
Madrigal Pharmaceuticals, Inc. - MGL-3196-19
A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients with Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis (MAESTRO-NASH OUTCOMES)
- Disease: NASH with Compensated Cirrhosis
- Status: Pending
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Vela Karakeshishyan, RN-BSN, FMD
- Contact: 305-243-4829 / vxk159@miami.edu
Novo Nordisk – NN9931-4553
The effect of Semaglutide in subjects with non-cirrhotic non-alcoholic steatohepatitis
- Disease: NASH advanced fibrosis (stage 3)
- Status: Open Enrollment
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Maria Lourdes Olson, FMD
- Contact: 305-243-6939 / malourdeso@med.miami.edu
Novo Nordisk – NN9500-4656
Efficacy and safety investigation of NNC0194-0499 co-administered with Semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial
- Disease: NASH cirrhotic and non-cirrhotic
- Status: Open Enrollment
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Maria Lourdes Olson, FMD
- Contact: 305-243-6939 / malourdeso@med.miami.edu
Zydus Therapeutics Inc. - SARO.20.002
A Phase 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects with Nonalcoholic Steatohepatitis and Fibrosis
- Disease: NASH
- Status: Open Enrollment
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Vela Karakeshishyan, RN-BSN, FMD
- Contact: 305-243-4829 / vxk159@miami.edu
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Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC)
Escient Pharmaceuticals - EP-547-201
Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
- Disease: Itching - PBC and PSC
- Status: Open Enrollment
- Principal Investigator: Dr. Cynthia Levy
- Clinical Research Coordinator: Felisa Padilla
- Contact: 305-243-7343 / fcp25@med.miami.edu
Genkyotex Suisse SA - GSN000350 (TRANSFORM)
A 52-week, Randomized, Placebo-controlled, Double-blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52-week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
- Disease: PBC
- Status: Open Enrollment
- Principal Investigator: Dr. Cynthia Levy
- Clinical Research Coordinator: Kenia Moreno, RN
- Contact: 305-243-9465 / kmoreno@med.miami.edu
GlaxoSmithKline - GSK 212620
A two-part, randomized, placebo controlled, double blind, multicenter, Phase 3 study to evaluate the efficacy and safety of linerixibat for the treatment of cholestatic pruritus in participants with primary biliary cholangitis (PBC)
- Disease: Itching - PBC
- Status: Open Enrollment (until June 21, 2023)
- Principal Investigator: Dr. Cynthia Levy
- Clinical Research Coordinator: Felisa Padilla
- Contact: 305-243-7343 / fcp25@med.miami.edu
Intercept Pharmaceuticals, Inc. – 747-214
A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination with Obeticholic Acid in Subjects with Primary Biliary Cholangitis
- Disease: PBC
- Status: Open Enrollment
- Principal Investigator: Dr. Cynthia Levy
- Clinical Research Coordinator: Katheryn Dae, FMD
- Contact: 305-243-1104 / kqd1@med.miami.edu
IPSEN - CLIN-60190-453
A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC)
- Disease: PSC
- Status: Open Enrollment
- Principal Investigator: Dr. Cynthia Levy
- Coordinator: Edisson J Aguilera Herrera, FMD
- Contact: 305-243-4648 / eja103@med.miami.edu
Mirum Pharmaceuticals, Inc. - VLX-301
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)
- Disease: PSC
- Status: Open Enrollment
- Principal Investigator: Dr. Cynthia Levy
- Clinical Research Coordinator: Edisson J Aguilera Herrera, FMD
- Contact: 305-243-4648 / eja103@med.miami.edu
Mirum Pharmaceuticals, Inc. - VLX-601
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (VANTAGE)
- Disease: PBC
- Status: Open Enrollment
- Principal Investigator: Dr. Cynthia Levy
- Clinical Research Coordinator: Edisson J Aguilera Herrera, FMD
- Contact: 305-243-4648 / eja103@med.miami.edu
Zydus Therapeutics Inc. - SARO.21.001
A Multicenter, Randomized, Double-blind, Placebo controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects with Primary Biliary Cholangitis
- Disease: PBC
- Status: Open Enrollment
- Principal Investigator: Dr. Cynthia Levy
- Clinical Research Coordinator: Kenia Moreno, RN
- Contact: 305-243-9465 / kmoreno@med.miami.edu
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Viral Hepatitis and HIV
GlaxoSmithKline – GSK 219288
Phase 3 Multi‑Center, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment with Bepirovirsen in HBeAg-negative Nucleos(t)ide Analogue treated Participants with Chronic Hepatitis B Virus (B‑Well 2)
- Disease: Hepatitis B
- Status: Pending
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Katheryn Dae, FMD
- Contact: 305-243-1104 / kqd1@med.miami.edu
Roche – WV41073
A Phase II, Randomised, Adaptive, Open-Label Platform Trial To Evaluate Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B
- v Disease: Hepatitis B
- v Status: Pending
- v Principal Investigator: Dr. Eugene Schiff, MD
- v Clinical Research Coordinator: Diane Sabogal, APRN
- v Contact: 305-243-1501 / d.sabogal@med.miami.edu
TARGET PharmaSolutions, Inc. - TARGET‐HBV
An Observational Study of Patients with Chronic Hepatitis B (CHB) Infection
- Disease: Hepatitis B
- Status: Open Enrollment
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Kenia Moreno, RN
- Contact: 305-243-9465 / kmoreno@med.miami.edu
Vir Biotechnology – VIR-2218-1006
A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Regimens Containing VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects with Chronic Hepatitis B Virus Infection
- Disease: Hepatitis B
- Status: Pending
- Principal Investigator: Dr. Eugene Schiff, MD
- Clinical Research Coordinator: Diane Sabogal, APRN
- Contact: 305-243-1501 / d.sabogal@med.miami.edu
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Additional Clinical Research Studies
Ascelia Pharma - ASC-Man-P016
A Multicentre, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients with Known or Suspected Focal Liver Lesions and Severe Renal Impairment
- Disease: Known or suspected focal liver lesions and severe renal impairment
- Status: Open Enrollment
- Principal Investigator: Dr. Beatriz Madrazo
- Clinical Research Coordinator: Edisson J Aguilera Herrera, FMD
- Contact: 305-243-4648 / eja103@med.miami.edu
BioVie Inc. – CIT-002
A Phase 2 Randomized, Controlled, Dose-titration, Open-Label Study Evaluating the Safety and Efficacy of BIV201 in Addition to Standard of Care Compared to Standard of Care to Reduce the Recurrence of Ascites and Complications in Patients with Refractory Ascites Secondary to Decompensated Liver Cirrhosis
- Disease: Refractory Ascites due to Decompensated Liver Cirrhosis
- Status: Open Enrollment
- Principal Investigator: Dr. Eric Martin
- Clinical Research Coordinator: Katheryn Dae, FMD
- Contact: 305-243-1104 / kqd1@med.miami.edu
Disc Medicine - DISC 1459-201 (AURORA)
A Randomized, Double-blind, Placebo-Controlled Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and Protoporphyrin IX (PPIX) Concentrations in Participants with Erythropoietic Protoporphyria (EPP)
- Disease: EPP - Erythropoietic Protoporphyria
- Status: Open Enrollment (until September 2023)
- Principal Investigator: Dr. Cynthia Levy
- Clinical Research Coordinator: Felisa Padilla
- Contact: 305-243-7343 / fcp25@med.miami.edu
Gilead Sciences, Inc. - GS-US-563-6041
A Phase 2 Randomized, Open-Label, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of Islatravir in Combination with Lenacapavir in Virologically Suppressed People with HIV
- Disease: HIV
- Status: Pending
- Principal Investigator: Dr. Dushyantha T. Jayaweera
- Clinical Research Coordinator: Vela Karakeshishyan, RN-BSN, FMD
- Contact: 305-243-4829 / vxk159@miami.edu
Porphyrias Consortium - PC7201
Rare Diseases Clinical Research Network Longitudinal Study of the Porphyrias
- Disease: Porphyrias
- Status: Open Enrollment
- Principal Investigator: Dr. Cynthia Levy
- Clinical Research Coordinator: Edisson J Aguilera Herrera, FMD
- Contact: 305-243-4648 / eja103@med.miami.edu
Ultragenyx Pharmaceutical Inc. – UX701-CL301
A Randomized, Double-blind, Placebo-controlled, Multicenter, Seamless, Adaptive, Safety, Dose-finding, and Phase 3 Clinical Study of UX701 AAV-mediated Gene Transfer for the Treatment of Wilson Disease
- Disease: Wilson Disease
- Status: Open Enrollment
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Maria Lourdes Olson, FMD
- Contact: 305-243-6939 / malourdeso@med.miami.edu