Clinical Research Trials : Additional Research

Additional Research

Hepatitis D Virus

(1) EIG-LNF-011-A PHASE 3, MATRIX DESIGN, PARTIALLY DOUBLE-BLIND, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF 50 MG LONAFARNIB/ 100 MG RITONAVIR BID WITH AND WITHOUT 180 MCG PEG IFN-ALFA-2A FOR 48 WEEKS COMPARED WITH PEG IFN-ALFA-2A ONOTHERAPY AND PLACEBO TREATMENT IN PATIENTS CHRONICALLY INFECTED WITH HEPATITIS DELTA VIRUS BEING MAINTAINED ON ANTI-HBV NUCLEOSIDE THERAPY (D-LIVR)

• Status: Open Enrollment, Open
• PI: Dr. Eugene Schiff
• Coordinator: Katheryn Dae
• Contact: (305) 243-1104 / kqd1@med.miami.edu

Hepatitus C Virus

(1) M14-222: An Open-Label, Multicenter Study to Evaluate the Long-term Outcomes with ABT-450/Ritonavir/ANT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZII)

• Status: Closed Enrollment, Open
• PI: Dr. Paul Martin
• Coordinator: Diane Sabogal
• Contact: (305) 243-1501 / d.sabogal@med.miami.edu

(2) GS-US-337-1431: A Registry for Subjects with Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment with a Sofosbuvir-Based Regimen without Interferon for Chronic Hepatitis C Infection in Gilead-Sponsored Trials

• Status: Closed Enrollment, Open
• PI: Dr. Eugene Schiff
• Coordinator: Lourdes Onate
• Contact: (305) 243-6939 / malourdeso@med.miami.edu

(3) HCVTARGET:Hepatitis C Therapeutic Registry and Research Network A Longitudinal, Observational Study

• Status: Closed Enrollment, Open
• PI: Dr. Eugene Schiff
• Coordinator: Deborah Jaffe
• Contact: (305) 243-9465 / dxj380@med.miami.edu

(4) HCV-Target PCORITHE PRIORITIZE STUDY: A Pragmatic, Randomized Study of Oral Regimens for Hepatitis C: Transforming Decision-¬‐Making for Patients, Providers, and Stakeholders.

• Status: Open Enrollment, Open
• PI: Dr. Eugene Schiff
• Coordinator: Katrina Munoz
• Contact: (305) 243-6500 / kxm759@med.miami.edu

Hyperammonemia/Hepatic Encephalopathy

(1) 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

• Status: Pending
• PI: Dr. Bhamidimarri
• Coordinator: Diane Sabogal
• Contact: (305) 243-1501 / d.sabogal@med.miami.edu

Autoimmune Hepatitis

(1) 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)

• Status: Open Enrollment, Open
• PI: Dr. Levy
• Coordinator: Lourdes Onate
• Contact: (305) 243-6939 / malourdeso@med.miami.edu

Coagulopathy

(1) RSX-201-A Phase 2a, Multicenter, Double-Blinded, Randomized, Comparator-Controlled Noninferiority Trial to Compare the Efficacy and Safety of Spray-Dried Solvent/Detergent-Treated Plasma (Resusix®) with Plasma Frozen Within 24 Hours After phlebotomy in Patients with Acquired Coagulopathy due to Confirmed or Suspected Hepatic Disease for the Treatment of Active Bleeding or Prophylaxis of Surgical Bleeding
Coagulopathy
• Status: Pending
• PI: Dr. Bhamidimarri
• Coordinator: Lourdes Onate, Katheryn Dae
• Contact: (305) 243-6939 / malourdeso@med.miami.edu

Hepatocellular Carcinoma

(1) TARGET-HCC-A 5-year Longitudinal Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma
HCC
• Status: Closed Enrollment, Open
• PI: Dr. Jones
• Coordinator: Deborah Jaffe
• Contact: (305) 243-9465 / dxj380@med.miami.edu

Overt Hepatic Encephalopathy

(1) RNHE2041-A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)

• Status: Closed Enrollment, Open
• PI: Dr. Eric Martin
• Coordinator: Katheryn Dae, Patricia Blenet
• Contact: (305) 243-1104 / kqd1@med.miami.edu