Clinical Trials

Hope in Action – Prospective Observational Study of HIV+ Deceased Donor Transplant for HIV+ Recipients
PI: Sander Florman, MD
Co-Investigators: Jawad Ahmad, MD; Scott Ames, MD; Antonios Arvelakis, MD; Charissa Chang, MD; Veronica Delaney, MD; Marcelo Facciuto, MD; Priya Grewal, MD; Shirish Huprikar, MD; Gene Im, MD; Rebecca Kent, MD; Leona Kim-Schluger, MD; Jennifer Leong, MD; Susan Lerner, MD; Lawrence Liu, MD; Madhav Menon, MD; Jang Moon, MD; Joseph Odin, MD; Meenakshi Rana, MD; Thomas Schiano, MD; Vinita Sehgal, MD; Ron Shapiro, MD; Nandita Singh, MD; Timothy Sullivan, MD; Parissa Tabrizian, MD; Vikram Wadhera, MD
Recruiting

Quark ReGIFT QRK306 - A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney
Sponsor: Quark Pharmaceuticals
PI: Scott Ames, MD
Co-Investigators: Antonios Arvelakis, MD; Veronica Delaney, MD; Sander Florman, MD; Rebecca Kent, MD; Susan Lerner, MD; Madhav Menon, MD; Vinita Sehgal, MD; Ron Shapiro, MD; Vikram Wadhera, MD
Recruiting

BMS IM103-116: Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (belatacept)-based Immunosuppression
Sponsor: Bristol-Myers Squibb
PI: Sander Florman, MD
Co-Investigators: Scott Ames, MD; Susan Lerner, MD; Vinita Sehgal, MD; Ron Shapiro, MD
Recruiting

CTOT-19 - Randomized Controlled Trial of Infliximab (Remicade) Induction Therapy for Deceased Donor Kidney Transplant Recipients
Sponsor: NIH/NIAID
PI: Madhav Menon, MD
Co-Investigators: Sander Florman, MD; Peter Heeger, MD; Ron Shapiro, MD
Recruiting

HIVTR-CCR5 – Impact of CCR5 Blockade in HIV+ Kidney Transplant Recipients
Sponsor: NIH/NIAID
PI: Barbara Murphy, MD
Co-Investigators: Peter Heeger, MD; Shirish Huprikar, MD
Recruiting

An Open-Label Phase I Safety Study of SANGUINATE Infusion in Patients with Acute Severe Anemia who are Unable to Receive Red Blood Cell Transfusion – Emergency Use Protocol
Sponsor: Prolong Pharmaceuticals
PI: Scott Ames, MD
Co-Investigator: Sander Florman, MD
Recruiting

CXCL9: Urinary Chemokines Response and Kinetics after Treatment for Biopsy-Proven Rejection in Kidney Transplant Recipients
PI: Peter Heeger, MD
Co-Investigators: Jessica Reid-Adam, MD
Recruiting

A Study to Identify Biomarkers of Graft Outcomes in Pediatric Kidney Transplant Recipients
Sponsor: CHLA
PI: Paolo Cravedi, MD
Co-Investigators: Corrine Benchimol, MD; Peter Heeger, MD; Jessica Reid-Adam, MD; Jeffrey Saland, MD
Recruiting

BMS ENLiST Observational Study Protocol IM103-076: Evaluating Nulojix Long-Term Safety in Transplant
Sponsor: Bristol-Myers Squibb
PI: Sander Florman, MD
Co-Investigators: Ron Shapiro, MD
Recruiting

SHP616-302 – A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cinryze® (C1 esterase inhibitor [human]) for the Treatment of Acute Antibody-Mediated Rejection in Kidney Transplant Patients
Sponsor: Shire ViroPharma, Inc.
PI: Nandita Singh, MD
Co-Investigators: Veronica Delaney, MD; Sander Florman, MD; Rebecca Kent, MD; Madhav Menon, MD; Vinita Sehgal, MD; Ron Shapiro, MD
Not yet recruiting

The PROTECT Study – A Prospective Observational Trial to evaluate the Correlation of T-Spot® Response to CMV Infection and T Cell-mediated Acute Graft Rejection
Sponsor: Oxford Immunotec, Inc.
PI: Shirish Huprikar, MD
Co-Investigators: Scott Ames, MD; Antonios Arvelakis, MD; Sander Florman, MD; Rebecca Kent, MD; Susan Lerner, MD; Vinita Sehgal, MD; Ron Shapiro, MD
Active, not recruiting

Eculizumab for Prevention of Delayed Graft Function in Deceased Donor Renal Transplantation
Sponsor Investigator: Peter Heeger, MD (Funded by Alexion Pharmaceuticals, Inc.)
PI: Peter Heeger, MD
Co-Investigators: Scott Ames, MD; Antonios Arvelakis, MD; Sander Florman, MD; Shirish Huprikar, MD; Susan Lerner, MD; Anita Mehrotra, MD; Vinita Sehgal, MD; Ron Shapiro, MD
Active, not recruiting

Hope in Action – Prospective Observational Study of HIV+ Deceased Donor Transplant for HIV+ Recipients
PI: Sander Florman, MD
Co-Investigators: Jawad Ahmad, MD; Scott Ames, MD; Antonios Arvelakis, MD; Charissa Chang, MD; Veronica Delaney, MD; Marcelo Facciuto, MD; Priya Grewal, MD; Shirish Huprikar, MD; Gene Im, MD; Rebecca Kent, MD; Leona Kim-Schluger, MD; Jennifer Leong, MD; Susan Lerner, MD; Lawrence Liu, MD; Madhav Menon, MD; Jang Moon, MD; Joseph Odin, MD; Meenakshi Rana, MD; Thomas Schiano, MD; Vinita Sehgal, MD; Ron Shapiro, MD; Nandita Singh, MD; Timothy Sullivan, MD; Parissa Tabrizian, MD; Vikram Wadhera, MD
Recruiting

A 36 month multi-center, open-label, randomized, comparator study to evaluate the efficacy and safety of everolimus immunosuppression treatment in liver transplantation for hepatocellular carcinoma exceeding Milan criteria
Sponsor: Baylor Research Institute
PI: Sander Florman, MD
Co-Investigators: Jawad Ahmad, MD; Antonios Arvelakis, MD; Charissa Chang, MD; Marcelo Facciuto, MD; Priya Grewal, MD; Gene Im, MD; Jennifer Leong, MD; Lawrence Liu, MD; Jang Moon, MD; Joseph Odin, MD; Ponni Perumalswami, MD; Thomas Schiano, MD; Myron Schwartz, MD
Recruiting

STOP-CO – A Pilot Study to Assess Safety, Tolerability, and Efficacy of Sofosbuvir and Ledipasvir for Hepatitis C Treatment in HIV/HCV Co-Infected Subjects Pre or Post Liver Transplant
Sponsor: NIH/NIAID (UCSF)
PI: Shirish Huprikar, MD
Co-Investigator: Sander Florman, MD
Recruiting

A Phase II Randomized Multicenter Placebo-Controlled Blinded Study of Sorafenib Adjuvant Therapy in High Risk Orthotopic Liver Transplant (OLT) Recipients with Hepatocellular Carcinoma (HCC)
Sponsor: UCLA
PI: Sander Florman, MD
Co-Investigators: Jawad Ahmad, MD; Celina Ang, MD; Charissa Chang, MD; Marcelo Facciuto, MD; Priya Grewal, MD; Jennifer Leong, MD; Lawrence Liu, MD; Jang Moon, MD; Joseph Odin, MD; Ponni Perumalswami, MD; Thomas Schiano, MD; Myron Schwartz, MD
Recruiting

An Open-Label Phase I Safety Study of SANGUINATE Infusion in Patients with Acute Severe Anemia who are Unable to Receive Red Blood Cell Transfusion – Emergency Use Protocol
Sponsor: Prolong Pharmaceuticals
PI: Scott Ames, MD
Co-Investigator: Sander Florman, MD
Recruiting

Protocol 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 Fresh Frozen Plasma (FFP) in Patients with Acquired Coagulopathy due to Confirmed or Suspected Hepatic Disease for the Treatment of Active Bleeding of Prophylaxis of Surgical Bleeding
Sponsor: Entegrion, Inc.
PI: Parissa Tabrizian, MD
Co-Investigators: Antonios Arvelakis, MD; Marcelo Facciuto, MD; Sander Florman, MD; Ganesh Gunasekaran, MD; Jang Moon, MD; Myron Schwartz, MD; Vikram Wadhera, MD
Not yet Recruiting

CAPSIL – Prophylaxis vs. Preemptive Therapy for CMV in R-D+ Liver Transplant Recipients
Sponsor: NIH/NIAID (University of Pittsburgh)
PI: Shirish Huprikar, MD
Co-Investigator: Thomas Schiano, MD
Active, not recruiting

The Assessment of Intrahepatic HCV Levels and Fibrosis at the Time of Liver Transplantation in Patients Receiving Antiviral Therapy while on the Liver Transplant Waiting List
Investigator Sponsor: Thomas Schiano, MD (Funded by Merck Sharpe & Dohme)
PI: Thomas Schiano, MD
Co-Investigators: Andrea Branch, MD; Isabel Fiel, MD; Sander Florman, MD; Yujin Hoshida, MD
Active, not recruiting

• A Prospective, Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants Requiring 28 Days of Parenteral Nutrition
  Sponsor: Fresenius Kabi
  PI: Joanne Lai, MD
  Co-Investigators: Ian Holzman, MD; Kishore Iyer, MD
  Recruiting

• GS-US-342-1143 – A Phase 2, Open-Label, Multicenter, Multicohort Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children with Chronic HCV Infection
  Sponsor: Gilead Sciences, Inc.
  PI: Ronen Arnon, MD
  Co-Investigators: Jaime Chu, MD
  Recruiting

• GS-US-337-1116 – A Phase 2, Open-Label, Multi-cohort Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children with Chronic HCV-Infection
  Sponsor: Gilead Sciences, Inc.
  PI: Ronen Arnon, MD
  Co-Investigators: Jaime Chu, MD
  Recruiting

• GS-US-337-1112: A Phase 2, Open-Label, Multicenter, Multi-cohort, Single-Arm Study to Investigate the Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children with Genotype 2 or 3 Chronic HCV Infection
  Sponsor: Gilead Sciences, Inc.
  PI: Ronen Arnon, MD
  Co-Investigators: Jaime Chu, MD
  Recruiting

• GS-US-334-1113 – A Long-Term Follow-Up Registry for Adolescent and Pediatric Subjects who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead Sponsored Chronic Hepatitis C Infection Trials
  Sponsor: Gilead Sciences, Inc.
  PI: Ronen Arnon, MD
  Co-Investigators: Jaime Chu, MD
  Recruiting

• Studies of Pediatric Liver Transplantation (SPLIT)
  Sponsor: SPLIT Network
  PI: Ronen Arnon, MD
  Co-Investigators: Jaime Chu, MD; Sander Florman, MD; Kishore Iyer, MD; Joanne Lai, MD
  Recruiting

• A Comparative Study of Antiviral Efficacy and Safety of Entecavir vs Placebo in Pediatric Subjects with Chronic Hepatitis B Virus (HBV) Infection who are HBeAg Positive
  Sponsor: Bristol-Myers Squibb
  PI: Ronen Arnon, MD
  Co-Investigator: Jaime Chu, MD
  Active, not recruiting

   

CONFIRM Study – A Multi-Center, Randomized Placebo-Controlled, Double-Blind Study to Confirm Efficacy and Safety of Terlipressin in Subjects with Hepatorenal Syndrome Type 1
Sponsor: Mallinckrodt Pharmaceuticals
PI: Priya Grewal, MD
Co-Investigators: Jawad Ahmad, MD; Charissa Chang, MD; Gene Im, MD; Jennifer Leong, MD; Lawrence Liu, MD; Joseph Odin, MD; Thomas Schiano, MD
Recruiting

Establishment of a Hepatitis B Registry at the Icahn School of Medicine at Mount Sinai
Sponsor: Gilead Sciences, Inc.
PI: Jennifer Leong, MD
Recruiting

IDN-6556-14: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Non-Alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension
Sponsor: Conatus Pharmaceuticals, Inc.
PI: Jawad Ahmad, MD
Co-Investigators: Charissa Chang, MD; Priya Grewal, MD; Gene Im, MD; Jennifer Leong, MD; Lawrence Liu, MD; Joseph Odin, MD; Thomas Schiano, MD
Not yet Recruiting

747-207 – A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Clinical Trial Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects with Primary Sclerosing Cholangitis
Sponsor: Intercept Pharmaceuticals, Inc.
PI: Thomas Schiano, MD
Co-Investigators: Jawad Ahmad, MD; Charissa Chang, MD; Priya Grewal, MD; Gene Im, MD; Jennifer Leong, MD; Lawrence Liu, MD; Joseph Odin, MD
Active, not recruiting

Multicenter Evaluation of the Reliability and Validity of the Live Donor Assessment Tool (LDAT) to Predict Psychosocial Outcomes Among Liver and Kidney Donors
Investigator Sponsor: MSSM (AST Award)
PI: Dianne LaPointe-Rudow, DNP
Co-Investigators: Julia Hunt; Brian Iacoviello, PhD; Akhil Shenoy, MD
Recruiting

Identification of Educational Needs and Determination of What Matters to Those Considering Live Kidney Donation
Sponsor: MSSM (ITNS Award)
PI: Dianne LaPointe-Rudow, DNP
Recruiting

I4T-MC-JVDE – A Global Second Line Phase 3 Study of Ramucirumab vs. BSC in Patients with AFP ≥ 400
Sponsor: Eli-Lily
PI: Charissa Chang, MD
Co-Investigators: Celina Ang, MD; Myron Schwartz, MD; Max Sung, MD
Recruiting

Pilot Study of EGFR Inhibition with Erlotinib in Cirrhosis to Inhibit Fibrogenesis and Prevent Hepatocellular Carcinoma
Sponsor: NCI/CPN (Subcontract with Mayo Clinic Rochester)
PI: Myron Schwartz, MD
Co-Investigators: Marcelo Facciuto, MD; Sander Florman, MD; Ganesh Gunasekaran, MD; Yujin Hoshida, MD; Josep Llovet, MD; Thomas Schiano, MD
Recruiting

A 36 month multi-center, open-label, randomized, comparator study to evaluate the efficacy and safety of everolimus immunosuppression treatment in liver transplantation for hepatocellular carcinoma exceeding Milan criteria
Sponsor: Baylor Research Institute
PI: Sander Florman, MD
Co-Investigators: Jawad Ahmad, MD; Antonios Arvelakis, MD; Charissa Chang, MD; Marcelo Facciuto, MD; Priya Grewal, MD; Gene Im, MD; Jennifer Leong, MD; Lawrence Liu, MD; Jang Moon, MD; Joseph Odin, MD; Ponni Perumalswami, MD; Thomas Schiano, MD; Myron Schwartz, MD
Recruiting

A Phase II Randomized Multicenter Placebo-Controlled Blinded Study of Sorafenib Adjuvant Therapy in High Risk Orthotopic Liver Transplant (OLT) Recipients with Hepatocellular Carcinoma (HCC)
Sponsor: UCLA (Funding by Bayer Healthcare Corporation)
PI: Sander Florman, MD
Co-Investigators: Jawad Ahmad, MD; Celina Ang, MD; Charissa Chang, MD; Marcelo Facciuto, MD; Priya Grewal, MD; Jennifer Leong, MD; Lawrence Liu, MD; Jang Moon, MD; Joseph Odin, MD; Ponni Perumalswami, MD; Thomas Schiano, MD; Myron Schwartz, MD
Recruiting

HEDS – Early Detection and Prognosis of Hepatocellular Carcinoma – Cirrhotic Control Follow-Up
Sponsor: NCI/EDRN (Subcontract with UTSW)
PI: Myron Schwartz, MD
Recruiting

Gut Microbiota in HCC Patients Before and After Surgery
Sponsor: NCI
PI: Myron Schwartz, MD
Co-Investigators: Sander Florman, MD; Ganesh Gunasekaran, MD
Recruiting

A Phase I/II Trial of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccine for Treatment of Hepatocellular Carcinoma
Sponsor: Saronic Biotechnology, Inc.
PI: Myron Schwartz, MD
Not yet recruiting

Prospective, Randomized Clinical Trial on 90Yttrium Trans-Arterial Radioembolization (Therasphere) Vs. Standard of Care (Sorafenib) for the Treatment of Advanced Hepatocellular Carcinoma (HCC) with Portal Vein Thrombosis (YES-P)
Sponsor: Biocompatibles
PI: Myron Schwartz, MD
Co-Investigators: Marcelo Facciuto, MD; Sander Florman, MD; Ganesh Gunasekaran, MD; Sherif Heiba, MD; Edward Kim, MD; Lale Kostakoglu, MD; Max Sung, MD
Active, not recruiting

TED-R13-002 – A Prospective, Multi-center Registry for Patients with Short Bowel Syndrome

Sponsor: Shire, Inc.
PI: Kishore Iyer, MD
Co-Investigators: Joanne Lai, MD; Jang Moon, MD
Not yet recruiting

Tracheal Airway and Transplant Program