Clinical Trials Sponsored by Grifols Biologicals, LLC

Total 155 results

Rachael Cusack
Grifols Biologicals, LLC

Recruiting

Microcirculation Properties of Albumin for Fluid Resuscitation in Septic Shock

Sepsis | Septic Shock | Sepsis, Severe

Ireland
Ottawa Hospital Research Institute
CSL Behring; Grifols Biologicals, LLC

Completed

Ig PRx in AECOPD: Pilot Study

Chronic Obstructive Pulmonary Disease

Canada
Grifols Therapeutics LLC

Active, not recruiting

Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD) (SPARTA)

Pulmonary Emphysema in Alpha-1 PI Deficiency

United States, Australia, Denmark, New Zealand, Estonia, Poland, Russian Federation, Sweden, Brazil, Canada, France, Finland
Grifols Therapeutics LLC

Completed

Efficacy, Pharmacokinetics, Safety, and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency

Primary Immunodeficiency

Spain, France, Germany, United Kingdom, Australia, Czechia, Hungary, Poland, Sweden
Grifols Therapeutics LLC

Withdrawn

Study Evaluating IGSC 20% Flexible Dosing in Treatment-Experienced and Treatment-Naive Subjects With Primary Immunodeficiency

Primary Immunodeficiency

United States
Grifols Therapeutics LLC

Completed

Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis

Myasthenia Gravis

United States, Belgium, Czechia, Estonia, Canada, France, Germany, Hungary, Poland, Lithuania
Grifols Therapeutics LLC

Completed

Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (ICE)

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

United States, Israel, Germany, Czech Republic, Mexico, Argentina, Canada, Italy, Poland, Serbia
Grifols Therapeutics LLC

Completed

Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic Fibrosis

Cystic Fibrosis

United States
Grifols Therapeutics LLC

Completed

A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients

Acute Ischemic Stroke

Spain, Australia, France, Austria, Serbia, Slovakia
Grifols Therapeutics LLC

Completed

Deposition of Inhaled Prolastin in Cystic Fibrosis Patients (CF2)

Cystic Fibrosis
Grifols Therapeutics LLC

Completed

An Open-label, Single-Arm Study to Evaluate the Safety and Rabies Virus Antibody Titers of Intramuscularly Administered Rabies Immune Globulin (Human)

Rabies

United States
Grifols Therapeutics LLC

Completed

Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency (SPARK)

Emphysema | Alpha 1-antitrypsin Deficiency (AATD)

United States
Grifols Therapeutics LLC

Completed

Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients

Common Variable Immunodeficiency | Severe Combined Immunodeficiency | Wiskott-Aldrich Syndrome | Agammaglobulinemia | Immunologic Deficiency Syndrome

Canada, United States
Hunter Holmes Mcguire Veteran Affairs Medical Center
Grifols Biologicals, LLC

Recruiting

Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement (HEAL-LAST)

Hepatic Encephalopathy | Cirrhosis

United States
City of Hope Medical Center
CSL Behring; Grifols Therapeutics LLC; Grifols Biologicals, LLC; Charta Foundation and other collaborators

Withdrawn

Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive (RESIST NAIVE)

Severe Hemophilia A
City of Hope Medical Center
CSL Behring; Grifols Therapeutics LLC; Grifols Biologicals, LLC; Charta Foundation and other collaborators

Completed

Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced) (RESIST EXP)

Severe Hemophilia A

United States
Grifols Therapeutics LLC
Instituto Grifols, S.A.

Active, not recruiting

Effects of Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites (PRECIOSA)

Decompensated Cirrhosis and Ascites

United States, Spain, Denmark, Belgium, Germany, Italy, Canada, Hungary, Poland, Bosnia and Herzegovina, Bulgaria, France, Serbia, United Kingdom
Instituto Grifols, S.A.

Withdrawn

FIB Grifols Congenital Deficiency for On-demand Treatment and Surgical Prophylaxis

Hypofibrinogenemia | Congenital Afibrinogenemia

India, Turkey, Lebanon, United States, Bulgaria
Instituto Grifols, S.A.
Instituto Grifols, S.A.

Completed

A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants

Excessive Bleeding During Surgery

Germany, United States, Bulgaria, France, Hungary, Romania, Serbia, United Kingdom, Canada, Sweden
Grifols Therapeutics LLC
Grifols Japan K.K.

Completed

Safety and Pharmacokinetics of Alpha-1 MP (Alpha1-proteinase Inhibitor (Human), Modified Process) in Participants With Alpha1-Antitrypsin Deficiency

Alpha1-Antitrypsin Deficiency

Japan
Instituto Grifols, S.A.

Completed

Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19

COVID-19

Spain
Instituto Grifols, S.A.

Completed

Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants With Coronavirus Disease (COVID-19)

COVID-19

Spain
Instituto Grifols, S.A.

Completed

A Study to Evaluate Safety and Efficacy of Convalescent Methylene Blue Treated (MBT) Plasma From Donors Recovered From Coronavirus Disease 2019 (COVID-19)

COVID-19

Spain
Grifols Therapeutics LLC

Recruiting

A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants With Alpha1-Antitrypsin Deficiency

Alpha1-Antitrypsin Deficiency

United States
Grifols Therapeutics LLC

Enrolling by invitation

Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency (SPARTA-OLE)

Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency

United States, New Zealand, Denmark, Australia, Finland, Estonia, Canada, Poland, Russian Federation, Sweden, France
Grifols Therapeutics LLC

Completed

A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency

Primary Immunodeficiency

United States
Grifols Therapeutics LLC

Terminated

Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19)

COVID-19

United States, Brazil, Chile, Colombia, Mexico
Grifols Therapeutics LLC

Completed

A Study to Assess the Efficacy and Safety of IGIV-C in Patients With Myasthenia Gravis Exacerbations

Myasthenia Gravis Exacerbations

Belgium, Poland, Canada, Argentina, Estonia, France, Hungary, Romania, Czechia, Latvia, Russian Federation, South Africa
Grifols Therapeutics LLC

Completed

Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency

Primary Immunodeficiency

United States, Canada
Grifols Therapeutics LLC

Completed

A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis

Myasthenia Gravis, Generalized

United States, Belgium, Czechia, Canada, Estonia, Lithuania, France, Germany, Hungary, Poland
Grifols Therapeutics LLC

Terminated

Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus

Type 1 Diabetes Mellitus

United States
Grifols Therapeutics LLC

Completed

A Study of Intra-thrombus Plasmin (Human) In Acute Peripheral Arterial Occlusion

Acute Peripheral Arterial Occlusion

United States, Peru, Belgium, Bulgaria, Czech Republic, Germany, India, Poland, Romania, Serbia, Slovakia, Spain
Grifols Therapeutics LLC

Completed

A Dose Escalation and Safety Study of Plasmin (Human) In Acute Lower Extremity Native Artery or Bypass Graft Occlusion (PRIORITY)

Arterial Occlusive Diseases

United States
Grifols Therapeutics LLC

Completed

Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis (PRIVIG)

Multiple Sclerosis, Relapsing-Remitting

Canada, Israel, United States, Austria, Czech Republic, Germany, Greece, Hungary, Poland, Slovakia, Sweden, United Kingdom
Grifols Therapeutics LLC

Completed

Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration

Macular Degeneration

Germany
Grifols Therapeutics LLC

Terminated

Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels

Tetanus

United States
Grifols Therapeutics LLC

Completed

A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency

Immunologic Deficiency Syndrome

United States, Canada
Grifols Therapeutics LLC

Completed

Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE)

Alpha 1-Antitrypsin Deficiency

Denmark, Sweden, United Kingdom
University of Texas Southwestern Medical Center
Grifols Biologicals, LLC; Dysautonomia International

Completed

IVIG (Gamunex-C) Treatment Study for POTS Subjects (iSTAND)

Postural Tachycardia Syndrome

United States
Columbia University
Grifols Therapeutics LLC

Completed

Intravenous Immunoglobulin (IVIG) in Lung Transplantation

Lung Transplantation | Hypogammaglobulinemia

United States
Instituto Grifols, S.A.
Hospital Clinic of Barcelona

Completed

Effects of Long Term Albumin 20% Administration in Patients With Cirrhosis and Ascites.

Cirrhosis | Ascites

Spain
Terra Biological LLC

Unknown

Anhydrous Enol-Oxaloacetate (AEO) on Improving Fatigue in Post-COVID-19 Survivors (AEO)

Treatment of Fatigue After Resolution of COVID-19 Infection

United States
Terra Biological LLC

Completed

Oxaloacetate Supplementation for Emotional PMS (OAA4PMS)

Premenstrual Syndrome (PMS)
Jena University Hospital
Novartis; Amgen; Grifols Biologicals, LLC; argenx; Swedish Orphan Biovitrum; University...

Recruiting

ITP Registry and Accompanying Biospecimen Collection (ITP-Registry)

Immune Thrombocytopenia

Germany
Grifols Therapeutics LLC
Covance; Clinipace Worldwide

Completed

Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass

Cardiac Surgery | Cardiopulmonary Bypass

United States
Aradigm Corporation
Grifols Therapeutics LLC

Completed

Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)

Non Cystic Fibrosis Bronchiectasis

United States, Italy, Poland, United Kingdom, France, Spain, Israel, Romania, Korea, Republic of, Australia, Canada, New Zealand, Hungary, Georgia, Former Serbia and Montenegro, Peru
Aradigm Corporation
Grifols Therapeutics LLC

Completed

Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)

Non Cystic Fibrosis Bronchiectasis

United States, Italy, Poland, Taiwan, United Kingdom, Germany, Spain, Israel, Romania, South Africa, Korea, Republic of, Australia, Canada, Hungary, Ireland, Latvia
University of California, Irvine
Grifols Therapeutics LLC

Completed

IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus

Cutaneous Lupus Erythematosus

United States
Institute for Human Genetics and Biochemistry
Grifols Biologicals, LLC; AIDS Community Research Initiative of America

Terminated

Safety and Efficacy of (α1Proteinase Inhibitor, α1PI) in HIV Disease

HIV Disease

United States
Direct Biologics, LLC

Recruiting

Study of ExoFlo for the Treatment of Perianal Fistulas

Crohn's Disease | Perianal Fistula

United States

Clinical Trials Sponsored by Grifols Biologicals, LLC

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