A Phase III Double-Blind, Randomized, Placebo Controlled, Multi Center Clinical Study to Evaluate the Efficacy and Safety of Intravenous L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects

This is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects. Eligible patients undergoing repair of a large unrestrictive ventricular septal defect (VSD), a partial or complete atrioventricular septal defect (AVSD), or an ostium primum atrial septal defect (primum ASD) will be eligible for enrollment.

开始日期2022-06-29

申办/合作机构

Asklepion Pharmaceuticals LLC

NCT04852172 / Terminated临床1/2期

A Phase I/IIA Open-label Dose-Finding Study with Subsequent Double-blind, Placebo-controlled, Randomized Study of L-citrulline in Sickle Cell Disease Presenting to Emergency Department (ED) in Vaso Occlusive Crisis (VOC) in Children, Adolescents and Young Adults (6 to 21 Years)

The purpose of this study is to determine if intravenous L-citrulline can abrogate an active vaso-occlusive crisis in sickle cell disease, resulting in decreased pain, reduction or elimination of opiate usage, and reduction or elimination of hospital admission. The applicant is developing intravenous L-citrulline (Turnobi™) for treatment of sickle cell disease (SCD). The current development program targets treatment of sickle cell-associated vaso-occlusive crisis (VOC) specifically. The aim of Part 1 is to identify the optimum dose regimens for the Part 2 of the trial which is a double-blind, placebo controlled adaptive 'pick-the-winner' design. This study will allow assignment of more subjects to the better treatment arm/s based on emerging data. The study, initially, will evaluate efficacy and tolerability of incremental doses of intravenous (IV) L-citrulline (Turnobi™) in patients with SCD while receiving standard of care therapy for VOC.

开始日期2021-04-29

申办/合作机构

Asklepion Pharmaceuticals LLC

NCT04570384 / Completed临床2期

Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Intravenous L-Citrulline (Turnobi) to Delay and Potentially Prevent the Need for Invasive Mechanical Ventilation for Acute Hypoxemic Respiratory Failure in Patients with COVID-19 (SARS-CoV2) Illness. To evaluate safety and efficacy of a bolus loading dose and continuous intravenous infusion of L-Citrulline compared to placebo in patients hospitalized with COVID-19 infection (SARS-CoV-2).

开始日期2020-10-15

申办/合作机构

Asklepion Pharmaceuticals LLC

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项与 Asklepion Pharmaceuticals LLC 相关的文献（医药）

2023-04-01·Contemporary clinical trials communications

Design of an adaptive randomized clinical trial of intravenous citrulline for sickle cell pain crisis in the emergency department

Article

作者: McKinley, K W ; Kalsi, G ; Darbari, D S ; Thomas, B ; Campbell, A ; Nickel, R S ; Chamberlain, J ; Margulies, S ; Berul, C ; Summar, M ; Majumdar, S

Background:

Vaso-occlusive pain crisis (VOC) is the most frequent cause for Emergency Department (ED) visits and hospital admissions for patients with sickle cell disease (SCD). Nitric oxide plays a critical role in the pathogenesis of vaso-occlusion. The amino acid, citrulline, is the main endothelial nitric oxide booster that offers the potential to ameliorate vaso-occlusion and decrease the risk of hospitalization.

Objective:

In this two-part study, the goal of the first part is to determine the pharmacokinetic profile of intravenous (IV) l-citrulline and optimal dose for the second part of the study, which is to determine the efficacy and tolerability of the intervention in patients with SCD.

Design:

A phase I/IIA open-label dose-finding study with subsequent double-blind, placebo-controlled, randomized Study of l-citrulline in children and adolescents with SCD presenting to the ED in VOC.

Methods:

Part 1: Subjects experiencing VOC are enrolled in an open-label, ascending dose of IV l-citrulline to identify the optimum dose with endpoints of pharmacokinetic parameters, pain scores, reduction of opioid use, quality of life, proportion admitted to the hospital for treatment of pain, readmission rates, and assessment of adverse events. Part 2 of the trial is a double-blind, placebo-controlled adaptive "pick-the-winner" design to evaluate the efficacy and tolerability of IV l-citrulline in patients with SCD while receiving standard of care therapy for VOC.

Summary:

This ED based sickle cell adaptive trial will determine the optimal dose for IV citrulline and whether the intervention improves outcome as a potential novel therapy for VOC in SCD.

项与 Asklepion Pharmaceuticals LLC 相关的新闻（医药）

2021-03-15

·GlobeNewswire

Emerging Drugs for the Acute Lung Injury Treatment: A Focus

Los Angeles, USA, March 15, 2021 (GLOBE NEWSWIRE) -- Emerging Drugs for the Acute Lung Injury Treatment: A Focus on Recent Clinical Trials A multitude of Clinical Trials Explore Acute Lung Injury Treatments as many dominant players such as Apeiron Biologics, Asklepion Pharmaceuticals, Viela Bio, ReAlta Life Sciences, Cantex Pharmaceuticals, and others are developing therapies. DelveInsight’s “Acute Lung Injury Pipeline Insight'' report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in the Acute Lung Injury pipeline landscapes. It comprises Acute Lung Injury pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Acute Lung Injury therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Acute Lung Injury pipeline products. Some of the significant features of the Acute Lung Injury Pipeline Report Get an overview of pipeline landscape @ Acute Lung Injury Clinical Trial Analysis Acute Lung Injury is a lung inflammation that develops in response to various pulmonary and generalized acute diseases. Acute Lung Injury Treatment is based on both ventilatory and non-ventilatory strategies. To date, the most significant advances in the supportive care of lung injury patients have been associated with improved ventilator management. Several clinical trials have shown that many pharmacologic strategies have not been effective in reducing mortality. Recent advances in understanding Acute Lung Injury pathophysiology have led to investigations of numerous potential pharmacologic treatments. Acute Lung Injury Emerging Drugs For further product profiles, request @ Acute Lung Injury Pipeline Therapeutics Scope of Acute Lung Injury Pipeline Drug Insight Key Questions regarding Current Acute Lung Injury Treatment Landscape and Emerging Therapies Answered in the Pipeline Report Table of Contents Get customized pipeline report @ Acute Lung Injury Drugs Pipeline Report Related Reports DelveInsight's Acute Kidney Injury Market Insights, Epidemiology, and Market Forecast 2030 report provides a detailed overview of the disease and an understanding of historical epidemiology. DelveInsight's Acute Renal Failure (ARF)- Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. DelveInsight's Tinea Pedis - Market Insights, Epidemiology, and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. DelveInsight's Trichotillomania- Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and an in-depth understanding of historical and forecasted epidemiology. DelveInsight’s Athlete’s foot-Market Insights, Epidemiology and Market Forecast-2030 report deliver an in-depth understanding of the Athlete’s foot, historical and forecasted epidemiology. DelveInsight's Urothelial Carcinoma - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. DelveInsight's Follicular Lymphoma - Market Insights, Epidemiology and Market Forecast - 2030 report provides an in-depth understanding of historical l and forecasted epidemiology. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

合作

2021-02-09

·BioSpace

Asklepion Pharmaceuticals LLC announces AWINSA Life Sciences as its Clinical safety and Pharmacovigilance Service provider for their clinical trials in their fight against COVID-19

PRINCETON, N.J., Feb. 09, 2021 (GLOBE NEWSWIRE) -- AWINSA Life Sciences, a Pharmacovigilance and Clinical Safety service provider announced that it has been selected as the preferred vendor for clinical safety management by Asklepion, a biopharmaceutical company for their upcoming trials. CMO Asklepion, Dr. Gurdyal Kalsi said, “We are very fortunate that we got this golden opportunity to contribute to the resolution of COVID-19 crisis. For this venture, we are excited to enter into a strategic alliance with AWINSA Life Sciences for clinical safety management, a team of intellectuals known for their proficiency in Pharmacovigilance and Clinical Safety.” “We are delighted to be a part of this project and our team of knowledgeable, experienced and exceptionally astute professionals will definitely give value addition to these important trials,” said Dr Sanjeev Miglani Founder and Director, AWINSA. The Co-Founder and Director of AWINSA, Dr Mugdha Chopra very rightly mentioned, “To overcome this nuanced and complicated COVID-19 crisis, the power of HOPE needs to be fuelled with scientific and authentic research. Asklepion has taken one step forward in this direction and we feel privileged to be a part of their prestigious trials.” About Asklepion Asklepion is a biopharmaceutical company based in Baltimore, Maryland. Asklepion Pharmaceuticals is dedicated to improving patients’ lives by identifying, developing and commercializing medicines which address unmet medical needs. They focus on the development of treatments for rare paediatric diseases. Asklepion strives to channel the powers of science and biotechnology into therapies that are lifesaving and to significantly improve the quality of life for sick children and anxious parents. They are led by team of seasoned executives who enrich the company with their extensive experience in various arenas. About AWINSA AWINSA is a service provider which provides end to end pharmacovigilance, medical information, medical writing and medical affairs services to Pharmaceutical and Biotech companies globally. Armed with wisdom and dedication, AWINSA aims to metamorphosize the pharmacovigilance world. The team has rock solid foundation of academics topped with sharp clinical acumen and expertise making them adept for this field. AWINSA has operations across the US, Europe and Asia. Contact information: Sanjeev Miglani, MD Director AWINSA Life Sciences info@awinsals.com +13152744862 59 E, Shrewsbury Place, Princeton, NJ 08540

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