Global Department CTA Block
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Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD/MASH)
Akero Therapeutics - AK-US-001-0105
Evaluating the safety and efficacy of efruxifermin in subjects with non-cirrhotic nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis
- Disease: MASH
- Status: Enrollment open
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Eliana Orta
- Contact: 305-243-0236 / ejo61@med.miami.edu
Akero Therapeutics - AK-US-001-0106
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of efruxifermin in subjects with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH)
- Disease: MASH cirrhosis
- Status: Enrollment open
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Eliana Orta
- Contact: 305-243-0236 / ejo61@med.miami.edu
Boehringer Ingelheim International - 1404-0044
A randomised, double-blind, placebo-controlled, multicentre, Phase III trial evaluating long-term efficacy and safety of survodutide weekly injections in adult participants with noncirrhotic non-alcoholic steatohepatitis/metabolic dysfunction-associated steatohepatitis (NASH/MASH) and (F2) - (F3) stage of liver fibrosis)
- Disease: MASH
- Status: Enrollment open
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Kenia Moreno, RN
- Contact: 305-243-9465 / kmoreno@med.miami.edu
Boehringer Ingelheim International - 1404-0064
A Phase III double-blind, randomised, placebo-controlled trial to evaluate liver-related clinical outcomes and safety of once weekly injected survodutide in participants with compensated nonalcoholic steatohepatitis/metabolic dysfunction associated steatohepatitis (NASH/MASH) cirrhosis
- Disease: MASH cirrhosis
- Status: Enrollment open
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Kenia Moreno, RN
- Contact: 305-243-9465 / kmoreno@med.miami.edu
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Primary Biliary Cholangitis (PBC)
COUR - CNP-104-CL-202
A Phase 2b Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of CNP-104 in Adults with Primary Biliary Cholangitis
• Disease: PBC
• Status: Enrollment opening soon
• Principal Investigator: Dr. Cynthia Levy
• Clinical Research Coordinator: Vela Karakeshishyan, MPH, BSN
• Contact: 305-243-4827 / vxk159@miami.eduGilead Sciences - CB8025-41837
AFFIRM: A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
- Disease: PBC with cirrhosis
- Status: Enrollment open
- Principal Investigator: Dr. Cynthia Levy
- Clinical Research Coordinator: Katheryn Dae, FMD
- Contact: 305-243-1104 / kqd1@med.miami.edu
Ipsen Biosciences - CLIN-60190-454
A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants with Primary Biliary Cholangitis (PBC)- Disease: PBC
- Status: Enrollment open
- Principal Investigator: Dr. Cynthia Levy
- Clinical Research Coordinator: Felisa Padilla
- Contact: 305-243-7343 / fcp25@med.miami.edu
Ipsen Biosciences - CLIN-60190-461
Prospective Non-Interventional, Phase IV Multicentre Study to Assess the Effectiveness, Safety and Tolerability of Elafibranor 80 Mg/Day in Patients with Primary Biliary Cholangitis Receiving Treatment in a Real-World Setting
- Disease: PBC
- Status: Enrollment open
- Principal Investigator: Dr. Cynthia Levy
- Clinical Research Coordinator: Zully Dominguez Franco
- Contact: 305-243-2394 / zdd10@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: Enrollment open
- Principal Investigator: Dr. Cynthia Levy
- Clinical Research Coordinator: Katheryn Dae, FMD
- Contact: 305-243-1104 / kqd1@med.miami.edu
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Primary Sclerosing Cholangitis (PSC)
LisCure - LB08-211
A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Safety and Efficacy of LB-P8 in Patients with Primary Sclerosing Cholangitis (PSC)
- Disease: PSC
- Status: Enrollment opening soon
- Principal Investigator: Dr. Cynthia Levy
- Clinical Research Coordinator: Vela Karakeshishyan, MPH, BSN
- Contact: 305-243-4827 / vxk159@miami.edu
PSC Partners Seeking a Cure - WIND-PSC-01
A Global Multi-Center Prospective Observational Cohort to Support Drug Development in Adult Patients with Primary Sclerosing Cholangitis (WIND-PSC Study)
- Disease: PSC
- Status: Enrollment open
- Principal Investigator: Dr. Cynthia Levy
- Clinical Research Coordinator: Felisa Padilla
- Contact: 305-243-7343 / fcp25@med.miami.edu
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Viral Hepatitis and HIV
Aligos Therapeutics - ALG-000184-202
A Randomized, Double-Blind, Active-Controlled Multicenter Phase 2 Study Evaluating the Efficacy and Safety of ALG-000184 Compared with Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg-Negative Adult Subjects with Chronic Hepatitis B Virus Infection (B-SUPREME)
- Disease: Hepatitis B
- Status: Enrollment open
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Gledys Martinez
- Contact: 305-243-4649 / glm91@med.miami.edu
ViiV - 222638
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons with HIV-1 (INNOVATE Study)
- Disease: HIV
- Status: Enrollment opening soon
- Principal Investigator: Dr. D. Jayaweera
- Clinical Research Coordinator: Kenia Moreno, RN
- Contact: 305-243-9465 / kmoreno@med.miami.edu
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Additional Clinical Research Studies
Disc Medicine - DISC 1459-301
APOLLO: A Randomized, Double-Blind, Placebo-Controlled Study of Bitopertin to Evaluate the Efficacy, Safety, and Tolerability in Participants with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
- Disease: EPP (Erythropoietic Protoporphyria) or XLP (X-Linked Protoporphyria)
- Status: Enrollment open
- Principal Investigator: Dr. Cynthia Levy
- Clinical Research Coordinator: Felisa Padilla
- Contact: 305-243-7343 / fcp25@med.miami.edu
Sanofi - EFC17359
A randomized, double-blind, Phase 3 study to evaluate the efficacy and safety of rilzabrutinib (SAR444671) compared to placebo in adult participants with active IgG4-related disease
- Disease: IgG4-related disease
- Status: Enrollment opening soon
- Principal Investigator: Dr. Jodie Barkin
- Clinical Research Coordinator: Eliana Orta
- Contact: 305-243-0236 / ejo61@med.miami.edu
Takeda Pharmaceuticals - TAK-999-3001
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency–Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis
- Disease: Alpha-1 Antitrypsin Deficiency-Associated Liver Disease
- Status: Enrollment open
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Diane Sabogal, APRN
- Contact: 305-243-1501 / d.sabogal@med.miami.edu
Takeda Pharmaceuticals - TAK-999-3002
A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency–Associated Liver Disease With METAVIR Stage F1 Fibrosis
- Disease: Alpha-1 Antitrypsin Deficiency-Associated Liver Disease
- Status: Enrollment open
- Principal Investigator: Dr. Eugene Schiff
- Clinical Research Coordinator: Diane Sabogal, APRN
- Contact: 305-243-1501 / d.sabogal@med.miami.edu
Vertex Pharmaceuticals - VX24-147-202
A Phase 2b, Open-label Study to Evaluate the Efficacy and Safety of Inaxaplin in Subjects With Proteinuric APOL1-mediated Kidney Disease With or Without Comorbidities that May Independently Contribute to Chronic Kidney Disease
- Disease: APOL1-mediated Kidney Disease with or without Comorbidities
- Status: Enrollment open
- Principal Investigator: Dr. D. Jayaweera
- Clinical Research Coordinator: Kenia Moreno, RN
- Contact: 305-243-9465 / kmoreno@med.miami.edu
Porphyrias Consortium - PC7201
Rare Diseases Clinical Research Network Longitudinal Study of the Porphyrias
- Disease: Porphyrias
- Status: Enrollment open
- Principal Investigator: Dr. Cynthia Levy
- Clinical Research Coordinator: Eliana Orta
- Contact: 305-243-0236 / ejo61@med.miami.edu
Glimpse
A Glimpse of Autoimmune Hepatitis in North America: A Collaborative Study by the North American Autoimmune Hepatitis Alliance
- Disease: Autoimmune Hepatitis
- Status: Enrollment opening soon
- Principal Investigator: Dr. Cynthia Levy
- Contact: 305-243-4615