ANZCTR search results

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD).

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in ulcerative colitis (UC).

The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).

This First-In-Human study will evaluate the safety and tolerability, pharmacokinetic profile, and pharmacodynamic effects of EP-7041, a novel Factor XIa inhibitor, following IV administration of single ascending doses in healthy normal volunteers, and following continuous IV infusions of multiple ascending doses in healthy normal volunteers.

The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.

Assess the efficacy and safety of ruxolitinib compared to Best Available Therapy (BAT) in patients with corticosteroid-refractory acute graft vs. host disease (aGvHD) after allogeneic stem cell transplantation.

The purpose of the present study is to assess the effects of LMB763 with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH

Impairment in physical function is a significant problem for survivors of critical illness. There is a growing urgency to develop a core set of outcome measures, which can be adopted in clinical and research practice to evaluate efficacy in response to interventions such as rehabilitation. Phase 1: Development of a new outcome measure. This study aims to examine the development of a single outcome measure which may be able to be utilised across the continuum of recovery of critical illness in the evaluation of physical function. The study will involve examination of two common physical function measures - the Physical Function in intensive care test scored (PFIT-s) and De Morton Mobility Index (DEMMI) and the development of a new measure based on rasch principles which may be able to capture physical functioning changes in individuals with critical illness. Aims: (1) To determine the clinical utility of two physical function measures (DEMMI and PFIT-s) when used in isolation across the hospital admission; and (2) To transform the (15-item) DEMMI and (4-item) PFIT-s into a single measure to evaluate function in intensive care survivors using Rasch analytical principles. Phase 2: Measurement properties of the PACIFIC physical function outcome measure in an independent validation sample.

This is a multicenter, 2-cohort Phase 2 study assessing both minimal residual disease (MRD)-guided discontinuation and fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with treatment-naïve CLL or SLL.