Research Studies - IIR/ECR

Research Studies - IIR/ECR

There are a number of Investigator-Initiated Research (IIR) and External Collaborative Research (ECR) studies related to Mallinckrodt products in varying stages of completion. Click on the links provided below to learn more.

To access our online submission portal please click here: IIR/ECR Portal

 

Investigator-Initiated Research (IIR) Studies

Acthar® Gel

ACTH as a Re-Emerging Therapy for Uveitis (The ACTHAR Study)

ACTH for Cutaneous Sarcoidosis Open Label Study

Acthar® Gel Stimulation of Neurosteroid Synthesis 

Acthar in Rheumatoid Arthritis, Histologic and Functional Effect on Synovium

Acthar in the Treatment of Lupus Nephritis

Adrenocorticotropic Hormone for Intraocular Inflammation in Post-operative Proliferative Vitreoretinopathy Patients

An Open Label, Multi-centered, Randomized Phase 2 Study to Evaluate the Safety, TolerabiLity and Bioactivity of Subcutaneous ACTH Gel in Patients with Scleritis: The ATLAS Study

A single-site, investigator-initiated, open-label trial of H.P. Acthar Gel in subjects with moderately to severely active ankylosing spondylitis (AS) 

Biomarkers to Characterize Subtypes of Neuroinflammation in Infantile Spasms and Responsiveness to ACTH

BRIGHT-MS Study: Utility of ADC Maps in Patients with Acute Demyelinating Lesions

Cardiac Sarcoidosis Registry

Changes in Autoreactive Memory B Cells as Biomarker of Response to ACTH in Patients with Membranous Nephropathy

Clinical and Electroencephalographic Treatment and Outcome Biomarkers in ACTH Treated Patients with Infantile Spasms

Clinical Efficacy of Acthar in Severe Dry Eye Patients

Clinical Impact of Acthar in the Psoriatic Arthritis Patient

Comparative Safety and Efficacy of ACTHar gel alone or in combination with oral Tacrolimus to reducing proteinuria in patients with idiopathic Fibrillary Glomerulopathy 

Cytokine Profile Before and After Acthar Treatment for Chronic Sarcoidosis

Effect of ACTH on Interactions Between Antigen Presenting Cells and CD4 Tcells - Relapsing Remitting MS

Effects of Acthar on Advanced MRI Surrogate Markers of Disease Activity and on Comprehensive Immune Signature During MS Relapses

Effects of Relapses on Longterm Outcomes in MS: CLIMB Study 

Efficacy and Safety of Acthar for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis

Evaluations of the Patterns and Predictors of Corticosteroid Efficacy in the Management of Disease Flares in RA

Experience with H.P. Acthar® Gel for Treatment of Patients with Nephrotic Syndrome Due to Various Etiologies and Its Effects on Podocyte Function

Exploring the Immunoregulatory Functions of Melanocortins

Mechanism of Action of Acthar Gel on Sarcoidosis Granulomas in a Novel Ex Vivo Model

Melanocortin Receptor Profiling in Dermatomyositis

MS Connect App: An Interactive Platform Connecting Physicians and Patients to Better Manage Multiple Sclerosis, Identify Relapses, and Improve Patient Quality of Life

Multicenter Trial of Acthar in the Treatment of Posttransplant Recurrent Focal Segmental Glomerulosclerosis

Ocular Sarcoidosis: Open Label Trial of Acthar Gel

Open-Label, Pilot Protocol of Patients with RA Who Were Treated with Acthar after an Incomplete Response to a Combination of DMARDs and Biologic DMARDs

Open Label Proof of Concept Study to Evaluate Efficacy and Safety of ACTH Gel in Refractory DM/PM

Open Label Prospective Study on the Efficacy of Repository Corticotropin (Acthar) in the Treatment of Non-infectious Retinal Vasculitis

Open Label Study to Evaluate Efficacy and Safety of Short-term Adjunctive Adrenocorticotropic Hormone (ACTH) Gel Therapy in Rheumatoid Arthritis

Phase 4 Trial of Neuroprotection with ACTH in Acute Optic Neuritis

Practice Patterns and Outcomes of Acthar use in Children with Nephrotic Syndrome

Treatment of Chronic Antibody-Mediated Rejection in Kidney Transplant with Acthar

Use of ACTH in RA Related Flares

Use of Acthar in CKD Stage V or ESRD Patients in Preparation for a Kidney Transplant

Use of CXCL9 as a Biomarker of Acthar Efficacy

Utilizing Magnetoencephalography (MEG) to Improve Outcomes for Infantile Spasms

Whole Exome Sequencing and ACTH Responsiveness in Infantile Spasms

 

INOmax®

A Prospective, Multicenter Registry for Premature Newborns with Severe Pulmonary Hypertension

A prospective randomized controlled trial of supplemental nitric oxide during cardiopulmonary bypass to reduce acute kidney injury after cardiac surgery

An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents with Non-Tuberculous Mycobacteria (NTM), Burkholderia spp,  Aspergillus spp and and Corona-like Viral (Sub-Study) Infections 

Effect of Nitric Oxide on Key Hox Transcription Factor Proteins During ELBW O2-Induced Lung Injury

Effects of Inhaled Nitric Oxide on Cerebral Blood Flow in Healthy Adults and Ischemic Stroke Patients

Efficacy of Nitric Oxide administration, during Cardiopulmonary Bypass in Neonates, in reducing the risk of Acute Kidney Injury: a pilot double-blind randomized controlled trial 

Exercising Capacity and Gas Exchange in Adults with a History of Bronchopulmonary Dysplasia

The impact of fluctuating arterial oxygen saturation on cerebral autoregulation in preterm infants with late onset hypoxemic respiratory failure 

Improvement in Acute Respiratory Parameters in Preterm Infants Under 34 Weeks Gestation after Initiation of INO in the Setting of Hypoxemic Respiratory Failure

Inhaled Nitric Oxide after Out-Of-Hospital Cardiac Arrest

Inhaled Nitric Oxide and Brain Outcomes after Pediatric Traumatic Brian Injury

Inhaled Nitric Oxide and Hypoxic Brain Injury in the Newborn

Inhaled Nitric Oxide Gas Therapy, in Mechanically Ventilated Patients with, Severe Acute Respiratory Syndrome in COVID-19 

INO following Traumatic Brain Injury 

Nitric Oxide (NO) - A potent anticoagulant for cardio pulmonary bypass (CPB) and Extracorporeal Membrane Oxygenator (ECMO) Therapy

Nitric Oxide Responsivity in Infants with Severe Chronic Lung Disease 

Nitric Oxide In Right Ventricular Dysfunction: Improvements In Clinical And Hemodynamic Parameters On VA ECMO (NOVICE) 

Prevention Of Transfusion Related Gut Injury (TRAGI) In ELGAN Neonates Using INO Proof Of Concept Pilot: The NO-TRAGI Trial 

Treatment of delayed pulmonary transition in extremely preterm infants & bronchopulmonary dysplasia 

Utilization of inhaled nitric oxide therapy in preterm infants in Canadian neonatal intensive care units

 

Terlipressin

Hemodynamic profile of Terlipressin and Octreotide in patients with cirrhosis and portal hypertension (HVPG ≥ 12mmHg)

The impact of continuous Terlipressin infusion on sarcopenia and ascites in end-stage liver disease

The impact of continuous Terlipressin infusion on cirrhotic cardiomyopathy in end-stage liver disease

The Impact of Acute-on-Chronic Liver Failure on Survival in Patients with Decompensated Cirrhosis

Predicting the response to Terlipressin: A Prospective clinical study

Prediction of Inpatient Outcomes using High-Throughput Metabolomics in a Multi-Center Cirrhosis Cohort

Terlipressin bolus vs continuous infusion in patients with Variceal hemorrhage

Terlipressin in the Treatment of Type-1 Hepatorenal Syndrome: Role of Inflammation in Disease Severity and Factors Associated with Response to Therapy

Terlipressin vs. Octreotide in the Control of Acute Gastroesophageal Variceal Hemorrhage: A retrospective Analysis of a large database 

Treatment Success and the Patient Journey in Hepatorenal Syndrome 

 

Therakos® – U.S.

Effect of New Cellex Photopheresis System on the Cellular Immunity in CTCL Patients

Extracorporeal Photopheresis for the Management of Progressive Bronchiolitis Obliterans Syndrome in Medicare-Eligible Recipients of Lung Allografts

Randomized phase II study of ECP in combination with corticosteroids for the initial treatment of aGvHD (Main Study) 

 

Therakos® – EU

Adaptive Immune Reconstitution, and assessment of life quality in a paediatric patients with acute GvHD treated with ECP 

Exploratory Study of Biomarkers Associated with Clinical Response to ECP in the Treatment of aGvHD and cGvHD Post Allogeneic Hematopoietic Stem Cell Transplantation HSCT

ECP/GVHD Prophylaxis Study

Large Single Center Retrospective Analysis of Efficacy of Extracorporeal Photopheresis in Treatment of Chronic Graft versus Host Disease

Multicenter analysis of efficacy and outcomes of extracorporeal photopheresis as treatment of chronic lung allograft dysfunction

Observational for ECP in acute or chronic GvHD after allogeneic hematopoietic stem cell transplantation for hematological malignancies

Phase II multicenter study of extracorporeal photopheresis plus standard steroid treatment for high risk acute graft-versus-host disease 

Prophylactic Use of Extracorporeal Photopheresis (ECP) after Lung Transplantation 

Registry of the therapeutic impact and quality of life of patients with graft versus host disease undergoing extracorporeal photopheresis 

 

External Collaborative Research (ECR) Studies

StrataGraft®

Interactions between Macrophages and Engineered Tissues

Pre-Clinical Assessment of StrataGraft™ for Deep Partial and Full Thickness Burns in Normal and SCID Pigs

Scarring in Stratagraft-treated vs. autograft-treated burn wounds: a clinical and histological investigation 

 

Terlipressin

A Multi-Center, Open Label, External Collaborative Research- ECR Study to treat HRS-AKI patients with Continuous Terlipressin Infusion