Clinical Research Trials : Additional Research

Additional Research

MNK61053106 – A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of MNK6105 (an Intravenous Formulation of L-Ornithine Phenylacetate) in Hospitalized Patients with Cirrhosis and Hyperammonemia Associated With an Episode of Hepatic Encephalopathy
o Classification: Hyperammonemia/Hepatic Encephalopathy
o Status: Pending
o PI: Dr. Bhamidimarri
o Coordinator: Diane Sabogal
o Contact: (305) 243-1501 / d.sabogal@med.miami.edu

AXA1665-A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of AXA1665 in Subjects with Liver Cirrhosis and Prior Overt Hepatic Encephalopathy (EMMPOWER)
o Classification: Cirrhosis/ Hepatic Encephalopathy
o Status: Pending
o PI: Dr. Eric Martin
o Coordinator: Edgar Medina
o Contact: (305) 243-0236 / ejm202@med.miami.edu

UX701-CL301-UX701 is an adeno-associated virus vector-based gene therapy indicated for the treatment of Wilson disease in adult and adolescent patients aged 12 years or older
o Classification: Wilson Disease
o Status: Pending
o PI: Dr. Cynthia Levy
o Coordinator: Patricia Blenet
o Contact: (305) 243 6968 / pmb45@med.miami.edu

IG1601-Prevention of Mortality with Long-Term Administration of Human Albumin in Subjects with Decompensated Cirrhosis and Ascites
o Classification: Cirrhosis/ Ascites
o Status: Pending
o PI: Dr. Arosemena
o Coordinator: Diane Sabogal
o Contact: (305) 243-1501 / d.sabogal@med.miami.edu

GS-US-536-5816 – A Phase 1b Randomized, Blinded, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination with Capsid Inhibitor Lenacapavir (GS-6207) in Virologically Suppressed Adults with HIV-1 Infection
o Classification: HIV
o Status: Pending
o PI: Dr. Jay
o Coordinator: Diane Sabogal
o Contact: (305) 243-1501 / d.sabogal@med.miami.edu

CVAY736B2201 -A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER)
o Classification: AIH
o Status: Open enrollment, Open
o PI: Dr. Cynthia Levy
o Coordinator: Lourdes Onate
o Contact: (305) 243-6939 / malourdeso@med.miami.edu

TARGET-HCC-A 5-year Longitudinal Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma
o Classification: HCC
o Status: Open enrollment, Open
o PI: Dr. Jones
o Coordinator: Olivia Blust
o Contact: (305) 243-2855 / oib5@med.miami.edu