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This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.
Conditions:
NASH - Nonalcoholic Steatohepatitis | MASH - Metabolic Dysfunction-Associated SteatohepatitisEmplacement:
- Akero Clinical Study Site, Edmonton, Alberta, Canada
- Akero Clinical Study Site, Vaughan, Ontario, Canada
- Akero Clinical Study Site, Montreal, Quebec, Canada
- Akero Clinical Study Site, Toronto, Ontario, Canada
- Akero Clinical Study Site, Terrebonne, Quebec, Canada
Sexe:
ALLÂges:
18 - 80This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin. Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo. Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.
Conditions:
Hypertension | Cardiovascular Diseases | Diabetes Mellitus, Type 2Emplacement:
- CaRe Clinic (Calgary), Calgary, Alberta, Canada
- Medical Arts Research (North Vancouver), North Vancouver, British Columbia, Canada
- QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
- KMH Cardiology Centres (Mississauga), Mississauga, Ontario, Canada
- Kawartha Cardiology Clinical Trials, Peterborough, Ontario, Canada
- Stouffville Medical Centre, Stouffville, Ontario, Canada
- Ecogene-21, Chicoutimi, Quebec, Canada
- Montreal Heart Institute, Montreal, Quebec, Canada
- Centre de Medecine Metabolique de Lanaudiere, Terrebonne, Quebec, Canada
- Medical Arts Research (Kelowna), Kelowna, British Columbia, Canada
- SMH Cardiology Clinical Trials Inc., Surrey, British Columbia, Canada
- Medical Trust Clinics, Courtice, Ontario, Canada
- James Cha, MD, Oshawa, Ontario, Canada
- Heart Health Institute (Scarborough), Scarborough Village, Ontario, Canada
- Women's College Hospital, Toronto, Ontario, Canada
- Diex Recherche (Joliette), Joliette, Quebec, Canada
- Endocrinologie Oasis Inc, Montreal, Quebec, Canada
- Fraser Clinical Trials, New Westminster, British Columbia, Canada
- GA Research Associates Ltd., Moncton, New Brunswick, Canada
- Centre for Studies in Family Medicine, Western University (LHRI), London, Ontario, Canada
- University of Ottawa Heart Institute, Ottawa, Ontario, Canada
- KMH Cardiology Centers (Hamilton), Stoney Creek, Ontario, Canada
- Diabetes Heart Research Centre, Toronto, Ontario, Canada
- THEO Medical - Concorde (Laval), Laval, Quebec, Canada
- Diex Recherche (Sherbrooke), Sherbrooke, Quebec, Canada
- CARe Clinic (Red Deer), Red Deer, Alberta, Canada
- Medical Arts Research (Penticton), Penticton, British Columbia, Canada
- Saul Vizel Medicine Professional Corporation, Cambridge, Ontario, Canada
- PACE (Partners in Advanced Cardiac Evaluation), Newmarket, Ontario, Canada
- CardioQuest Research Centre, Sarnia, Ontario, Canada
- St. Michael's Hospital, Toronto, Ontario, Canada
- ViaCar Recherches Cliniques Inc. (Greenfield Park), Greenfield Park, Quebec, Canada
- McGill University Health Centre (MUHC), Montreal, Quebec, Canada
- Diex Recherche (Trois-Rivieres), Trois-Rivières, Quebec, Canada
Sexe:
ALLÂges:
Over 18This is an open-label study to be conducted in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG). Each participant must have completed all required visits per protocol in the parent study AROAPOC3-2003 (USA and Canada participants only; NCT# 05413135), AROAPOC3-3001(Canada and Japan participants only; NCT05089084), AROAPOC3-3003 (NCT06347003), AROAPOC3-3004 (NCT06347016) or AROAPOC3-3009 (Argentina, Italy, South Africa, and Spain; NCT06347133). Subjects who previously met all eligibility requirements for AROAPOC3-3003 or AROAPOC3-3004 and were not permitted to proceed to randomization per the Sponsor's direction in order to prevent excessive over-enrollment may also be enrolled in this trial. The subjects must meet all other applicable eligibility criteria prior to enrollment and have an HbA1c results of \<=10% within 30 days prior to Day 1. Subjects entering this OLE from AROAPOC3-2003 must meet the following additional criteria to be considered for enrollment in addition to applicable eligibility criteria: 1. HbA1c ≤10% within 30 days prior to Day 1 2. Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND fulfill either (c) or (d) 3. Baseline fasting TG level of ≥500 mg/dL and prior history of acute pancreatitis at the time of enrollment into AROAPOC3-2001 4. Baseline fasting TG level of ≥1000 mg/dL at the time of enrollment into AROAPOC3-2001 All eligible participants will receive plozasiran administered subcutaneously (SC) approximately every 3 months for 24 months. Participants will be counseled to remain on the specified low-fat diet throughout the study in accordance with local standard of care.
Conditions:
HypertriglyceridemiaEmplacement:
- Research Site 4, Québec, Quebec, Canada
- Research Site 6, Chicoutimi, Quebec, Canada
- Research Site 5, Montreal, Quebec, Canada
- Research Site 7, London, Ontario, Canada
- Research Site 20, Victoria, British Columbia, Canada
- Research Site 19, Québec, Quebec, Canada
Sexe:
ALLÂges:
Over 18RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
Conditions:
Systemic Lupus Erythematosus | Lupus NephritisEmplacement:
- Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada
Sexe:
ALLÂges:
18 - 65This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \<6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to \<6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase. Study details include: Part A: The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period). Part B: For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A \[4-week Screening and a 52-week treatment period\] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).
Conditions:
Asthma | WheezingEmplacement:
- Investigational Site Number : 1240006, Montreal, Quebec, Canada
- Investigational Site Number : 1240005, Sherbrooke, Quebec, Canada
- Investigational Site Number : 1240007, Hamilton, Ontario, Canada
- Investigational Site Number : 1240001, Vancouver, British Columbia, Canada
- Investigational Site Number : 1240002, Edmonton, Alberta, Canada
- Investigational Site Number : 1240008, Burlington, Ontario, Canada
Sexe:
ALLÂges:
2 - 5A Phase 1b/2 study to explore the safety, efficacy and pharmacokinetics of EP-104GI in adults with eosinophilic esophagitis (EoE). Endoscopic and histologic assessments will also be evaluated to understand the local effects of EP-104GI on eosinophilic EoE disease activity. Approximately 27 to 33 participants will be enrolled in dose escalation: 3-6 participants per dose cohort. The number of participants enrolled in escalation will depend on the number of dose escalation cohorts evaluated, and dose cohorts needing to be expanded. An additional 10-24 participants will be enrolled in 1 or 2 cohorts of 10-12 participants each at tolerable dose regimen(s) selected based on the accumulated clinical data to identify the recommended phase 2 dose(s) (RP2D). In the Phase 2 randomized dose optimization portion of the study, approximately 120 subjects will be randomized to Dose A (120 mg total dose), Dose B (160 mg total dose), or matching vehicle control, with an overall assignment ratio of 1:1:1. The total number of participants in both portions of the study will be approximately 160. The study involves 8-10 site visits spread over approximately 52 weeks. Participants in an extended PK sub study will have up to 4 additional visits, to a maximum of 108 weeks post-dose. The participants will either receive the active study drug (EP-104GI) or matching vehicle control. Matching vehicle control will be used only in randomized dose optimization portion of the study. Participants randomized to receive vehicle control may receive EP-104GI (Dose A or Dose B) following the completion of Week 24 providing they meet eligibility criteria for crossover to EP-104GI. Participants randomized to receive EP-104GI on Day 0 will not receive EP-104GI or vehicle control at Week 24. The study drug or matching vehicle control will be administered by qualified personnel during an esophagogastroduodenoscopy (EGD) procedure at the Baseline/Dosing visit. Safety will be assessed throughout the study. Blood and urine samples will be collected at site visits for laboratory assessments and to measure plasma levels of EP-104GI. Participants will complete questionnaires to assess symptoms of dysphagia and odynophagia and will undergo 3-5 EGDs with esophageal biopsies at the Baseline, Week 4 (dose escalation phase only), Week 12, Week 24 (randomized dose optimization phase only), Week 26, and Week 52 (randomized dose optimization phase only).
Conditions:
Eosinophilic EsophagitisEmplacement:
- McGill University Health Center, Montréal, Quebec, Canada
- G.I. Research Institute, Vancouver, British Columbia, Canada
- McGill University Health Center, Montreal, Quebec, Canada
- UoA - South Edmonton Gastroenterology Research Clinic, Edmonton, Alberta, Canada
- University of Calgary, Calgary, Alberta, Canada
Sexe:
ALLÂges:
18 - 75This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion. Enrollment is open only for the 1b Expansion CPI-Naive NSCLC cohort.
Conditions:
Gastric Cancer | Melanoma | Colorectal Cancer | Esophageal Cancer | Cervical Cancer | NSCLC | Urothelial Carcinoma |...Emplacement:
- British Columbia Cancer Agency, Vancouver, British Columbia, Canada
- Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, Canada
- Sir Mortimer B Davis Jewish General Hospital, Montreal, Quebec, Canada
- Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Sexe:
ALLÂges:
Over 18The main objective of the study is to characterize safety and efficacy of 2 dose levels of AMG 193 by investigator, and to evaluate AMG 193 monotherapy efficacy by Blinded Independent Central Review (BICR).
Conditions:
MTAP-deleted NSCLCEmplacement:
- William Osler Health System - Brampton Civic Hospital, Brampton, Ontario, Canada
- Princess Margaret Cancer Centre, Toronto, Ontario, Canada
- Cross Cancer Institute, Edmonton, Alberta, Canada
- McGill University Health Centre Glen Site, Montreal, Quebec, Canada
- London Health Sciences Centre, London, Ontario, Canada
Sexe:
ALLÂges:
18 - 99This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.
Conditions:
Inflammatory Bowel Diseases | Ulcerative Colitis | Colitis, Ulcerative | ColitisEmplacement:
- Site 083, London, Ontario, Canada
Sexe:
ALLÂges:
Over 18The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
Conditions:
Breast NeoplasmsEmplacement:
- Princess Margaret Cancer Centre ( Site 0310), Toronto, Ontario, Canada
- Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0308), Rimouski, Quebec, Canada
- Jewish General Hospital ( Site 0303), Montreal, Quebec, Canada
- BC Cancer Surrey ( Site 0315), Surrey, British Columbia, Canada
- Southlake Regional Health Centre ( Site 0311), Newmarket, Ontario, Canada
- CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0302), Québec, Quebec, Canada
- CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0301), Montreal, Quebec, Canada