Clinical Trials Sponsored by Direct Biologics, LLC

Total 104 results

Instituto Grifols, S.A.

Completed

Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery

Vascular Surgical Bleeding

United States, Hungary, Russian Federation, Serbia
Instituto Grifols, S.A.
Grifols Biologicals, LLC

Completed

Efficacy and Safety of Plasma Exchange With 5% Albumin in Beta-amyloid Peptide Clearance in Cerebral Spinal Fluid

Alzheimer's Disease

Spain, United States
Instituto Grifols, S.A.

Completed

Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients

Liver Transplantation | Hepatitis B

Italy
Instituto Grifols, S.A.

Completed

Clinical Trial in Patients Diagnosed With Immune Thrombocytopenic Purpura (ITP)

Immune (Idiopathic) Thrombocytopenic Purpura

Spain, Russian Federation, United Kingdom
Instituto Grifols, S.A.

Completed

Efficacy and Safety of Intramuscular HBIG Grifols for the Prevention of Recurrence After Liver Transplantation

Hepatitis B, Chronic

Italy
University of Washington
Grifols Biologicals, LLC

Withdrawn

Monotherapy IVIG Gamunex-C for HMG-CoA Reductase Auto-Antibody Positive Necrotizing Myopathy Treatment (The MIGHT Trial)

Immune-Mediated Necrotizing Myopathy

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

Completed

A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease (AMBAR)

Alzheimer's Disease

Spain, United States
Instituto Grifols, S.A.

Completed

Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Surgery

Hemostasis

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

Completed

IGIV Study for Chronic ITP Patients Ages 3-70

Idiopathic Thrombocytopenic Purpura

United States, India, Puerto Rico, Canada
Grifols Biologicals, LLC
Instituto Grifols, S.A.

Completed

Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries

Soft Tissue Surgical Bleeding

United States, Hungary, Serbia
Instituto Grifols, S.A.

Completed

Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries

Parenchymous Tissue Surgical Bleeding

United States, Hungary, Russian Federation, Serbia
Instituto Grifols, S.A.

Completed

Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects

Primary Immune Deficiency Disease

United States
Instituto Grifols, S.A.

Completed

Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

Coronary Artery Bypass | Acquired Antithrombin III Deficiency

Italy
Instituto Grifols, S.A.

Completed

Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis

Target Bleeding Site During Peripheral Vascular Surgery

Canada, United Kingdom, Spain
Instituto Grifols, S.A.

Completed

Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation

Hepatitis B, Chronic

Spain
Terumo BCT
Yale University; Versiti; Key Biologics, LLC; LeukoLab

Completed

Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Healthy Blood Donors

Leukapheresis

United States
University of Iowa
DJO Incorporated; Direct MS Canada; Pinnaclife Inc.; TZ Press, LLC

Completed

Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)

Multiple Sclerosis

United States
Children's Hospital Los Angeles
Grifols Biologicals, LLC

Active, not recruiting

Preventing Inhibitor Recurrence Indefinitely (PRIORITY)

Hemophilia A | Immune Tolerance

United States
Brigham and Women's Hospital
Biological Illumination LLC

Completed

Investigating the Effects of Evening Light Exposure on Melatonin Suppression, Alertness and Nocturnal Sleep

Non-visual Photoreception

United States
Vanderbilt University
Duke University; Grifols Biologicals, LLC

Completed

Albumin Administration and Outcomes in Cardiac Surgery

Thoracic Surgery
Applied Biologics, LLC
Fondren Orthopedic Group L.L.P.; Texas Orthopedic Hospital

Unknown

Efficacy of an Amniotic Fluid Derived Allograft, (FlōGraft®) in Rotator Cuff Repairs: A Prospective Study

Rotator Cuff Tear | Fatty Atrophy

United States
Universidad Autonoma de Nuevo Leon
LifeNet Health; Lynch Biologics LLC

Recruiting

Periodontal Regeneration With Recombinant Human Platelet Derived Growth Factor (rH-PDGF-BB) and Allograft

Periodontal Diseases

Mexico
Thomas Klootwyk, MD
Signature Biologics, LLC; KLM Solutions, LLC

Not yet recruiting

Study to Assess Signature Cord Product in Patients With Symptomatic OA of the Knee

Osteoarthritis, Knee
Enrique Ginzburg
Grifols Biologicals, LLC

Terminated

Antithrombin III in Infectious Disease Caused by COVID-19

Covid19 | Antithrombin III Deficiency

United States
University of California, San Diego
Grifols Biologicals, LLC

Completed

Fluid Mobilization in Hospitalized Patients With Acute Kidney Injury

Fluid Overload | Hypotension During Dialysis
The Methodist Hospital Research Institute
Grifols Biologicals, LLC

Completed

Improving Adherence to Rabies PEP Guideline Recommendations

Rabies | Rabies Human | Rabies Virus Infection

United States
University of Kansas Medical Center
Terra Biological LLC

Completed

A Pilot Study of Oxaloacetate in Subjects With Treated PD

Parkinson's Disease

United States
The Methodist Hospital Research Institute
Grifols Biologicals, LLC

Recruiting

Survey of Human Rabies Immune Globulin Safety in Children

Rabies | Rabies Human | Pediatrics | Rabies Virus Infection

United States
University of Kansas Medical Center
Terra Biological LLC

Not yet recruiting

Oxaloacetate in Myasthenia Gravis

Myasthenia Gravis

United States
Beth Israel Deaconess Medical Center
Grifols Biologicals, LLC

Terminated

The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes

Diabetes Mellitus | Diabetes Complications | Diabetic Neuropathies

United States
Children's Hospital Medical Center, Cincinnati
Grifols Biologicals, LLC

Completed

Evaluation Of The Pharmacokinetics Of Antithrombin III In Neonates And Infants Undergoing CPB And ECMO Support

Cardiopulmonary Bypass | Extracorporeal Membrane Oxygenation Complication

United States
University of Alabama at Birmingham
Grifols Biologicals, LLC

Completed

Post-bypass Prophylactic IVIG in Infants and Neonates

Congenital Heart Disease | Hypogammaglobulinemia

United States
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
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
Omar Jawdat
Terra Biological LLC

Completed

Trial of Oxaloacetate in ALS (TOALS)

ALS

United States
InBios International, Inc.
Biomedical Advanced Research and Development Authority; Fast-Track Drugs &...

Completed

Evaluation of the Clinical Specificity of the Active Anthrax Detect™ Plus (AAD Plus) Lateral Flow Immunoassay (LFI)

Anthrax

United States
InBios International, Inc.
Biomedical Advanced Research and Development Authority; Fast-Track Drugs &...

Completed

Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA

Zika Virus Infection

United States
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
Ology Bioservices
Pharm-Olam, LLC; Chemical, Biological, Radiological, and Nuclear Medical

Withdrawn

Study of Adalimumab or Placebo in Patients With Mild to Moderate COVID-19 (COMBAAT) (COMBAAT)

Mild to Moderate COVID-19
M.D. Anderson Cancer Center
National Cancer Institute (NCI); Prometheus Laboratories; Key Biologics, LLC; Adelson...

Active, not recruiting

Lymphodepletion Plus Adoptive Cell Transfer With or Without Dendritic Cell Immunization in Patients With Metastatic Melanoma

Melanoma

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
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
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
Fondazione Salvatore Maugeri
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia; Grifols... and other collaborators

Completed

Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency (AATD)

Alpha-1 Antitrypsin Deficiency
Quadram Institute Bioscience
Biotechnology and Biological Sciences Research Council; University of Reading; Technology Strategy Board, United Kingdom and other collaborators

Completed

Broccoli and Vascular Health Study (BASH)

Cardiovascular Diseases

United Kingdom
Pop Test Oncology LLC
Baylor College of Medicine; Michael E. DeBakey VA Medical Center; Congressionally... and other collaborators

Completed

Effects of Ethanol on the Pharmacokinetics of PT-150 (Formerly ORG34517) (PT150 PK Study)

Potential Treatment for Alcohol Dependence-Alcohol Interaction

United States
Pop Test Oncology LLC
Baylor College of Medicine; University of California, San Diego; Michael E. DeBakey... and other collaborators

Completed

Clinical Trial to Evaluate the Safety of PT150 (Formerly ORG34517) When it is Taken Concurrently With Alcohol

Alcohol Dependence | Alcohol Interaction

United States
Biologics & Biosimilars Collective Intelligence...
Merck Sharp & Dohme LLC; Pfizer; AbbVie; University of Pittsburgh; Boehringer Ingelheim and other collaborators

Completed

Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis

Rheumatoid Arthritis | Psoriasis | Psoriatic Arthritis | Inflammatory Bowel Disease | Ankylosing Spondylitis

Clinical Trials Sponsored by Direct Biologics, LLC

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