Stuart Roberts - Projects - Monash University

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Research activity per year

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15 Finished
21 Active

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A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT 303 in Adults with Advanced or Metastatic GPC3-Expressing Cancers, including Hepatocellular Carcinoma
Roberts, S.
25/09/24 → 24/09/26
Project: Research
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)
Roberts, S.
18/09/24 → 17/09/26
Project: Research
A Phase 1 Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INI-822 in Healthy Volunteers and Participants with Non-Alcoholic Steatohepatitis (NASH) Or Presumed NASH
Roberts, S. & Mitchell, J.
27/08/24 → 26/08/26
Project: Research
A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod Alone and in Combinations in Subjects with Chronic Hepatitis B Infection
Roberts, S.
17/08/24 → 17/08/26
Project: Research
A Long-Term Follow-up Study for Subjects with Chronic Hepatitis B Previously Treated with Imdusiran (AB-729)
Roberts, S.
22/05/24 → 22/05/30
Project: Research
A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Combination Compared to Zibotentan Monotherapy as well as Zibotentan/Dapagliflozin and Zibotentan Monotherapy Compared to Placebo in Participants with Cirrhosis
Roberts, S. & Lewis, P.
2/04/24 → 1/04/26
Project: Research
A Phase 3, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Safety and efficacy of Efruxifermin in subjects with Non-Cirrhotic Non-alcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Roberts, S.
1/02/24 → 2/02/26
Project: Research
An Open-label Study Evaluating the Safety, Antiviral Activity, and Pharmacokinetics of IMC-I109V in HLA-A*02:01 Positive Patients with Chronic HBV who are Non-Cirrhotic, Hepatitis B e Antigen-negative, and Virally Suppressed
Roberts, S. & Mitchell, J. L.
12/01/24 → 11/01/26
Project: Research
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-Invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Roberts, S.
17/11/23 → 17/11/25
Project: Research
An Open-Label Phase 1b Study Evaluating the Safety, Tolerability, Immunogenicity and Antiviral Activity of Multiple Doses of CLB-3000 in Subjects with Chronic Hepatitis B
Roberts, S. & McKenzie, J.
2/08/23 → 1/08/25
Project: Research
ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
Roberts, S.
11/10/22 → 10/10/27
Project: Research
A Phase IIb/III Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Cotadutide in Participants with Noncirrhotic Non-alcoholic Steatohepatitis with Fibrosis (PROXYMO-ADVANCE)
Roberts, S.
1/06/22 → 31/08/27
Project: Research
TRANSFORM: A 52-week, Randomized, Placebo-controlled, Double-blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52-week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness.
Roberts, S.
26/02/22 → 1/01/26
Project: Research
A Phase 2a, Randomized, Blinded, Multicenter Study Investigating a Combination of AB-729 and VTP-300 in Virologically-Suppressed Chronic Hepatitis B Participants.
Roberts, S.
1/02/22 → 31/12/24
Project: Research
Efficacy and safety investigation of NNC0194-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial
Roberts, S.
9/09/21 → 31/12/24
Project: Research
RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Roberts, S.
16/07/21 → 31/12/24
Project: Research
A Multicentre, Observational, Phase 4 Study to Evaluate the Safety and Tolerability of Lenvatinib in Patients with Advanced or Unresectable Hepatocellular Carcinoma (STELLAR)
Roberts, S. & Lewis, P.
28/05/21 → 31/12/27
Project: Research
A Double-Blinded, randomized, Parallel-Group, PHASE 2 Study to investigate the Effect of RO7049665 on the time to relapse following steroid tapering in patients with Autoimmune Hepatitis
Roberts, S. & Jones, A.
1/03/21 → 31/12/24
Project: Research
A Phase 2, Randomized, Double-blinded, Placebo-controlled, Multicenter, Dose-finding Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects with Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
Roberts, S.
19/12/19 → 31/12/24
Project: Research
RECIPE: Randomised controlled trial (RCT) of ROTEM-guided blood component administration versus standard of care in patients with cirrhosis and coagulopathy undergoing invasive procedures.
Majeed, A., Janko, N. E., Roberts, S., Kemp, W., Nandurkar, H. & Gow, P. J.
5/12/19 → 20/12/24
Project: Research
A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (resmetirom) in Patients with Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation. Clinical study No. MGL-3196-11.
Roberts, S.
24/10/19 → 31/12/24
Project: Research