Godoy-cruz Mendoza, Argentina
Study of Plozasiran in Adults With Severe Hypertriglyceridemia
Phase
3Span
119 weeksSponsor
Arrowhead PharmaceuticalsGodoy Cruz, Mendoza
Recruiting
Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis
The safety and immunogenicity of RUTI was established in healthy volunteers, patients with latent tuberculosis (TB); and Drug Susceptible (DS) -TB and Drug resistance (DR)-TB. This study proposed to evaluate the safety and efficacy of the RUTI vaccine in patients with active pulmonary TB. Immunotherapy for TB could shorten the sputum culture conversion, therefore reduce the time required to cure. Therapeutic vaccines do not interfere directly with the causative organism and hence, they are not involved in the development of drug resistance. Therapeutic vaccination would also be beneficial for DS-TB as it could increase the response to the standard therapy and help diminish the development of drug resistance. The vaccination stimulates the immune response during the continuation phase of TB treatment in which the remaining bacteria are poorly sensitive, if not refractory, to antimycobacterial agents, and potentiate chemotherapy. Reducing the huge reservoir of mycobacterium tuberculosis (DS or not) by vaccination strategies could ultimately accelerate elimination of the disease worldwide. As per the results of the Phase II clinical trial in patients with latent TB, the best polyantigenic response was obtained with a dose of 25µg of RUTI vaccine and the second inoculation did not further increase the response. Based on these findings, a single dose of 25µg of vaccine will be used in the study. The objective of this study is to i) explore the efficacy as reduction of bacillary load through the study of early bactericidal activity (EBA) in patients with DS-TB; and ii) provide data from safety perspective of the vaccine RUTI (25 µg FCMtb) in patients with TB, when given concomitant with the standard of care treatment initiation. The study will include patients diagnosed with pulmonary DS-TB, candidate to start treatment with standard-care TB drugs and without any disease that could compromise the assessment of the response to the vaccination, or increase the risk of adverse events. RUTI will be administered on the day of TB treatment start, EBA will be measured on days 2, 4, 7, 10, 12, and 14, and adverse events will be collected up to week 24. Other measurements will be performed to assess the sputum culture conversion (SCC), clinical, X-ray or laboratory worsening, improvement of clinical signs and symptoms, and health-related quality-of-life (HRQOL).
Phase
2Span
114 weeksSponsor
Archivel Farma S.L.Godoy Cruz, Mendoza
Recruiting
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
Phase
3Span
151 weeksSponsor
Teva Branded Pharmaceutical Products R&D, Inc.Godoy Cruz
Recruiting
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
Buloxibutid is an oral angiotensin II type 2 (AT2) receptor agonist and has been shown to improve lung function in IPF over 36 weeks. Buloxibutid agonizes the AT2 receptor on alveolar epithelial type 2 cells (AEC2s), which are believed to play a central role in the disease. Buloxibutid has been demonstrated preclinically to improve AEC2 viability, alveolar integrity via surfactant secretion and epithelial repair via replenishment of gas exchange alveolar epithelial type 1 cells (AEC1s). This leads to decreasing downstream profibrotic signaling, enhancing resolution of existing fibrotic tissue via upregulation of collagenase matrix metalloproteinases, and addressing vascular disfunction associated with the disease. The trial will include participants who are on stable licensed IPF therapy or who are currently not treated with a licensed IPF therapy. The latter group will include participants intolerant or not responsive to licensed IPF therapies, participants ineligible to receive these therapies, and participants who have voluntarily declined to receive a licensed IPF therapy after being fully informed of the potential benefits and risks of such therapy. Due to the potential risk of drug-drug interactions (DDIs), concomitant treatment with pirfenidone is not allowed in this trial. Participants who are not on antifibrotic therapy at study start may initiate such treatment during the study. The trial is planned to enroll 270 participants, 90 participants on oral buloxibutid 100 mg BID, 90 participants on oral buloxibutid 50 mg BID, and 90 participants on oral placebo BID for 52 weeks. The treatment will be blinded and treatment allocation will be randomized. The primary measurement will be based on spirometry, measuring the forced vital capacity (FVC). The trial consists of 3 consecutive periods: a screening period of up to 6 weeks, a 52-week treatment period, and a follow-up period of 2-4 weeks after the 52-week visit. The study procedures have been planned with focus on optimizing patient convenience while allowing a safe conduct and strict scientific rigor. Trial website: www.aspire-ipf.com
Phase
2Span
121 weeksSponsor
Vicore Pharma ABGodoy Cruz
Recruiting
A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight
Phase
3Span
138 weeksSponsor
Eli Lilly and CompanyGodoy Cruz, Mendoza
Recruiting
Study to Assess the Efficacy and Safety of Atuliflapon in Moderate-to-Severe Uncontrolled Asthma
The study will enroll participants with moderate to severe uncontrolled asthma who are on low-dose inhaled corticosteroid (ICS) - a long-acting beta-agonist (LABA) or medium-to-high-dose ICS with or without LABA background treatment. The study will be initiated by Lead-in pharmacokinetics (PK) cohort in asthma participants. Participant will be randomised globally, including participants in Lead-in PK cohort (2 arms) and in Part 1 of the study (2 arms). In the Lead-in PK cohort, participants will be randomised to Atuliflapon or placebo (recruitment completed). In Part 1 of the study, participants will be stratified by geographical region, and grouped based on high or low levels of biomarker at screening (Visit 1).
Phase
2Span
209 weeksSponsor
AstraZenecaGodoy Cruz
Recruiting
A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)
Phase
3Span
265 weeksSponsor
Eli Lilly and CompanyGodoy Cruz, Mendoza
Recruiting
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
Phase
3Span
253 weeksSponsor
Eli Lilly and CompanyGodoy Cruz, Mendoza
Recruiting