Clinical Trials Sponsored by Grifols Therapeutics LLC

Total 445 results

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Withdrawn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
Grifols Therapeutics LLC

Recruiting

A Study to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment (SMT) Compared to Placebo Plus SMT to Prevent Infections in Participants With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia

Bacterial Infections | B-cell Chronic Lymphocytic Leukemia | Hypogammaglobulinemia

United States, Bulgaria, Poland, Romania, Serbia
Grifols Therapeutics LLC

Completed

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency

Primary Immunodeficiency

United States
Grifols Therapeutics LLC

Terminated

A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients (COVID-19)

COVID-19 | Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

Spain
Grifols Therapeutics LLC

Completed

Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)

COVID-19

United States
Grifols Therapeutics LLC

Completed

Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human) (GamaSTAN)

Anti-Hepatitis A Antibody Levels in Heathy Subjects

United States
Grifols Therapeutics LLC

Completed

A Study to Assess Safety and PK of Liquid Alpha₁-Proteinase Inhibitor (Human) in Treating Alpha₁-Antitrypsin Deficiency

Alpha₁-Antitrypsin Deficiency

United States
Grifols Therapeutics LLC

Completed

Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP

Purpura, Thrombocytopenic, Idiopathic

United States
Grifols Therapeutics LLC

Completed

Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency (KIDS)

Primary Immunodeficiency

United States
Grifols Therapeutics LLC

Completed

Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults (ChAMP)

Alpha 1-Antitrypsin Deficiency

United States
Grifols Therapeutics LLC

Completed

The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency (STAMP)

Alpha 1-Antitrypsin Deficiency

United States, United Kingdom
Grifols Therapeutics LLC
Grifols Biologicals, LLC

Terminated

Alphanate in Immune Tolerance Induction Therapy

Hemophilia A, Congenital

United States, Spain, Italy, India, Canada, Russian Federation
Grifols Therapeutics LLC
Grifols Biologicals, LLC

Completed

Efficacy and Safety of Plasma Exchange With Albutein® 5% in Participants With Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis

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

Recruiting

Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5% (APACHE)

Acute-On-Chronic Liver Failure

United States, United Kingdom, Spain, Germany, Italy, Belgium, France, Austria, Denmark, Portugal
Grifols Therapeutics LLC
Grifols Japan K.K.

Completed

Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE)

Alpha1-Antitrypsin Deficiency

Japan
Grifols Therapeutics LLC
Instituto Grifols, S.A.

Completed

Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia (IG0902)

Congenital Afibrinogenemia

India, United States, Italy, Lebanon
Grifols Therapeutics LLC
Instituto Grifols, S.A.

Recruiting

Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand Disease

Von Willebrand Disease

Spain
Instituto Grifols, S.A.

Terminated

Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF in Patients With Post-polio Syndrome (FORCE)

Post-polio Syndrome

United States, Denmark, Spain, Germany, Poland, Canada, Czechia, Italy, Netherlands
Instituto Grifols, S.A.

Completed

Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Dysfunction, Renal and Cerebral Function in Cirrhotic Patients With "Acute-on-chronic Liver Failure"

Liver Failure | Liver Cirrhosis

Spain
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

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