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Sibley Memorial Hospital

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Liver Clinical Trials

Chronic/Advanced Liver Disease/Liver Transplantation

VTI – 206

Description:Open label, randomized controlled trial that seeks to evaluate the utility of a cell-based liver assist device in patients with alcoholic hepatitis.
PI:Kirti Shetty, MD
NCT:NCT01829347
Contact:Suburban Hospital — Kate Levy 301-896-2672

STOP-HE

Description:Placebo controlled, randomized trial in patients with cirrhosis and hepatic encephalopathy requiring hospitalization.
PI:Kirti Shetty, MD
NCT:NCT01966419
IRB:IRB00035034
Contact:Sibley Memorial Hospital — Kate Levy 202-660-5571

Biotest 988

Description:A phase 2 B study of hepatitis C immunoglobulin in hepatitis C positive recipients undergoing liver transplantation.
PI:Kirti Shetty, MD
NCT:NCT01804829
Contact:Johns Hopkins Hospital — Mina Attia 443-287-8816
Sibley Memorial Hospital — Kate Levy 202-660-5571

HALT-HE

Description:Registry trial which aims to collate information on patients with hepatic encephalopathy, managed both inpatient and in the clinic in terms of symptoms, medications, provider documentation.
PI:Kirti Shetty, MD
Contact:Sibley Memorial Hospital — Kate Levy 202-660-5571

Conatus 6556-11 HVPG

Description:A placebo-controlled, randomized trial in patients with cirrhosis and portal hypertension who will be administered a novel anti-fibrotic, caspase inhibitor.
PI:Kirti Shetty, MD
NCT:NCT02230683
Contact:Sibley Memorial Hospital — Kate Levy 202-660-5571

Vitamin D as a chemopreventive agent in cirrhosis

Description:A Phase 1 study to assess the safety and tolerability of high dose vitamin D in cirrhosis
PI:Kirti Shetty, MD
NCT:NCT01956864
Contact:Sibley Memorial Hospital — Kate Levy 202-660-5571

The C-WORTHY Study

Description:Efficacy and safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in chronic hepatitis C participants with Child-Pugh (CP)-B hepatic insufficiency.
PI:Saleh Alqahtani, MD
NCT:NCT02115321

CENTAUR Trial

Description:This study evaluates the efficacy and safety of Cenicriviroc for the treatment of NASH in adult subjects with liver fibrosis.
PI:Saleh Alqahtani, MD
NCT:NCT02217475

ATRAL-4 Trial

Description:This study evaluates efficacy and safety of Sofosbuvir/GS-5816 Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis.
PI:Mark Sulkowski, MD
NCT:NCT02201901

GS-US-337-0123

Description:A Phase 2, multicenter, open-label study to investigate the safety and efficacy of Sofosbuvir/Ledipasvir fixed-dose combination + Ribavirin administered in subjects infected with chronic HCV who have advanced liver disease or are post-liver transplant.
PI:Mark Sulkowski, MD
NCT:NCT01938430

Hepatocellular Carcinoma / Liver Tumor

1. DEBDOX study, J1306, NCT 02007954
This study investigates the safety and feasibility of novel, small drug eluting beads (70-150 micron) in patients with HCC.
PI: Jean-Francois Geschwind, MD

2. Therasphere Dose Distribution study, J1289, not listed on NCT
This study evaluates the dosing distribution to tumor and normal liver during Therasphere procedures.
PI: Jean-Francois Geschwind, MD

3. Conventional TACE with PK, J14131, NCT# pending
This study evaluates the pharmacokinetics (PK) of doxorubicin following conventional TACE, to determine if newer TACE administration techniques result in lower systemic exposure of doxorubicin.
PI: Jean-Francois Geschwind, MD

4. Lipiodol study, J12115, NCT01877187 This study investigates whether lipiodol, the carrier of the chemotherapy drugs used for TACE procedures, can be used as a biomarker of tumor response.
PI: Jean-Francois Geschwind, MD

5. 3D Roadmap, J11113, NCT01818440
This study is investigating the optimal imaging to use during TACE procedures, the current standard or a newer ‘3D roadmap’ imaging software.
PI: Jean-Francois Geschwind, MD

6. ACRIN, 6690
Prospective, multicenter comparison of CT scan vs MRI of liver for hepatocellular carcinoma in orthotopic liver transplantation (OLT) allocation.
PI: Kirti Shetty, MD

7. Sorafenib plus doxorubicin study, ECALGB80802, NCT01015833
Phase 3, randomized study of sorafenib plus doxorubicin versus sorafenib in patients with advanced HCC.
PI: David Cosgrove, MD

8. ADI PEG20 study, J1209, NCT01287585
Randomized, placebo-controlled, phase 3 trial of ADI PEG20 versus placebo in patients with advanced HCC who have failed prior systemic therapy
PI: David Cosgrove, MD

9. EDT study, J1271, NCT01642186
A randomized, 3-arm study of everolimus, estrogen deprivation therapy (EDT) and everolimus plus EDT in patients with unresectable fibrolamellar carcinoma (FLC)
PI: David Cosgrove, MD

10. Lirilumab study, J1282, NCT01714739
A phase 1, dose escalation and cohort expansion study of the safety and efficacy of anti-Kir (Lirilumab) in combination with anti-PD1 (Nivolumab) in advanced HCC.
PI: William Sharfman