Clinical Trials Sponsored by Baxalta Innovations GmbH, now part of Shire

Total 114 results

Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire

Completed

Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects

Primary Immunodeficiency Diseases (PID)

Denmark, United Kingdom, Czechia, France, Greece, Hungary, Slovakia, Sweden
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire

Completed

Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice

Acquired Hemophilia A

United States, Italy, United Kingdom, Germany, Austria, Netherlands, France
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire

Terminated

BAX 802 in CHA With Inhibitors (CHAWI)

Hemophilia A

Netherlands, Spain, Italy, Turkey, Bulgaria, United States, Canada, Germany, Norway, Poland, Russian Federation, South Africa
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire

Completed

Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A

Acquired Hemophilia A

United States
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire

Completed

Phase 3/4 Study of a Recombinant Protein-Free Factor VIII (rAHF-PFM): Comparison of Continuous Infusion Versus Intermittent Bolus Infusion in Hemophilia A Subjects Undergoing Major Orthopedic Surgery

Hemophilia A

United States, Belgium, France, Norway, Netherlands, Austria, Hungary, Italy, Poland, Portugal, Romania, Russian Federation, Spain, Sweden
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire

Completed

Real-world CANadian CUvitru Non-Interventional Study in Subjects Transitioning From Subcutaneous Immunoglobulin (CANCUN)

Primary Immunodeficiency Diseases (PID)

Canada
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire

Completed

ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD) (AHEAD)

Hemophilia A

Czechia, Switzerland, Denmark, Canada, Australia, Austria, France, United Kingdom, Italy, Sweden, Belgium, Brazil, China, Colombia, Greece, Hungary, Norway, Poland, Portugal, Russian Federation, Slovenia, Spain
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire

Completed

A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) With Ramp-up and No Ramp-up Dosing in Healthy Adult Participants

Healthy Volunteers

United States
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire

Completed

FEIBA Reconstitution Volume Reduction and Faster Infusion Study (FEIBA STAR)

Hemophilia A or B With Inhibitors

Croatia, North Macedonia, Ukraine
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire

Completed

RIXUBIS PMS India (RIXUBIS PMS)

Hemophilia B

India
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire

Completed

Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia

Exposure During Pregnancy

Poland, Czechia, United States, Germany, Slovakia
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire

Completed

Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects

Primary Immunodeficiency Diseases (PID)

United States
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire

Completed

BAX 855 PK-guided Dosing (PROPEL)

Hemophilia A

Spain, United States, Australia, Singapore, Taiwan, Hong Kong, Malaysia, Bulgaria, United Kingdom, Switzerland, Ukraine, Turkey, Italy, Norway, France, Austria, Romania, Sweden, Poland, Germany, Hungary, Israel
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire

Completed

BAX 855 Continuation

Hemophilia A

United States, Spain, Netherlands, Australia, Czechia, Korea, Republic of, Taiwan, Poland, Bulgaria, United Kingdom, Germany, Turkey, Israel, Malaysia, Ukraine, Russian Federation, Austria, Switzerland, Japan, Hong Kong, Lithuania, Roman... and more
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire

Terminated

Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency

Chronic Obstructive Pulmonary Disease | Alpha1-antitrypsin Deficiency

United States, Canada, Australia
Takeda
Baxalta Innovations GmbH, now part of Shire

Completed

rVWF IN PROPHYLAXIS

Von Willebrand Disease

United States, Spain, Italy, Turkey, Germany, Russian Federation, Netherlands, France, Canada
Baxalta now part of Shire
Baxter Innovations GmbH

Completed

Phase 1/2 Lyme Vaccine Study

Prophylaxis of Lyme Borreliosis

Germany, Austria
Baxalta now part of Shire
Baxter Innovations GmbH

Terminated

Early Prophylaxis Immunologic Challenge (EPIC) Study (EPIC)

Hemophilia A

Poland, United States, Bulgaria, Serbia, Canada, Russian Federation, Germany, Netherlands, Lithuania, Czechia, Austria, Spain
Baxalta now part of Shire
Baxter Innovations GmbH

Completed

BAX 855 Dose-Escalation Safety Study

Hemophilia A

Japan, Bulgaria, Germany, United Kingdom
Baxalta now part of Shire
Takeda Development Center Americas, Inc.; Baxalta Innovations GmbH, now part...

Active, not recruiting

A Study of BAX 888 in Male Adults With Severe Hemophilia A

Hemophilia A

United States, Spain, Hungary, Italy, Germany, Austria, France
Takeda
RTI Health Solutions; Baxalta Innovations GmbH, now part of Shire

Completed

A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

United States
Baxalta now part of Shire

Completed

A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID)

Primary Immunodeficiency Diseases (PID)

Japan
Baxalta now part of Shire
Takeda

Completed

RIXUBIS Drug Use-Result Survey (Japan)

Hemophilia B

Japan
Baxalta now part of Shire

Terminated

A Phase 1/2 Study of SHP648, an Adeno-Associated Viral Vector for Gene Transfer in Hemophilia B Subjects

Hemophilia B

Turkey, Spain
Baxalta now part of Shire

Completed

Safety and Efficacy Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients Undergoing Surgery

Hemophilia A

United States
Baxalta now part of Shire

Completed

Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders

Primary Immunodeficiency Diseases (PID) | Immune Thrombocytopenic Purpura (ITP) | Kawasaki Syndrome

United States
Baxalta now part of Shire

Completed

Phase 2/3 Study of IGSC, 20% in PIDD

Primary Immunodeficiency Diseases (PID)

United States, Canada
Baxalta now part of Shire

Terminated

Evaluation of Different Dose Regimens of Aes-103 Given for 28 Days to Subjects With Stable Sickle Cell Disease

Sickle Cell Disease

United Kingdom
Baxalta now part of Shire

Completed

BAX 855 Pediatric Study

Hemophilia A

United States, Spain, United Kingdom, Taiwan, Malaysia, Bulgaria, Hong Kong, Korea, Republic of, Netherlands, Turkey, Ukraine
Baxalta now part of Shire

Completed

Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)

Hemophilia A

United States, Spain, Netherlands, Australia, Czechia, Korea, Republic of, Poland, Germany, Taiwan, Israel, Ukraine, United Kingdom, Malaysia, Japan, Austria, Switzerland, Sweden, Bulgaria, Lithuania, Romania
Baxalta now part of Shire

Completed

Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients

Hemophilia B

Poland, United Kingdom, Spain, Bulgaria, Romania, Japan, Russian Federation, Brazil, Chile, Sweden, Colombia, Ukraine, Argentina, Czechia
Baxalta now part of Shire

Completed

BAX 326 Surgery Study in Hemophilia B Patients

Hemophilia B

Colombia, Bulgaria, Chile, Poland, Romania, Argentina, Czechia, Russian Federation, Ukraine, United Kingdom
Baxalta now part of Shire

Terminated

Long-Term Study of IGIV, 10% in Alzheimer´s Disease

Alzheimer´s Disease

United States
Baxalta now part of Shire

Completed

Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD

Primary Immunodeficiency Diseases (PID)

United States
Baxalta now part of Shire

Completed

Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A

Acquired Hemophilia A

United States, Canada, India, United Kingdom
Baxalta now part of Shire

Terminated

Prevention of Graft-Versus-Host Disease in Patients With Advanced Leukemia or Lymphoma Who Are Eligible for Peripheral Stem Cell Transplantation

Lymphoma | Leukemia | Graft Versus Host Disease

United States, Australia
Baxalta now part of Shire

Completed

Phase 1 Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Solid Tumors

Malignant Solid Tumors | Metastatic Adenocarcinoma of the Colon or Rectum

Germany, United States
Baxalta now part of Shire

Terminated

First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients

Hemophilia

United Kingdom
Baxalta now part of Shire

Completed

Phase 1 Dosing Study of BAX 513 in Healthy Volunteers

Healthy Volunteers

Austria
Baxalta now part of Shire

Completed

Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand Disease

Von Willebrand Disease

United States, Germany, United Kingdom, Italy, Austria, Canada
Baxalta now part of Shire

Completed

Study of Pharmacokinetics, Efficacy, and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients With Hemophilia A

Hemophilia A

United States, Canada, Puerto Rico
Baxalta now part of Shire

Completed

ADVATE 2 mL Post-Authorization Safety Surveillance (PASS)

Hemophilia A | Congenital Factor VIII (FVIII) Deficiency

United Kingdom, France, Germany, Hungary
Baxalta now part of Shire

Completed

GAS-Hem Feasibility Study

Hemophilia A

Canada, United States
Baxalta now part of Shire

Terminated

Phase 1/2a Two-Arm Dose-Escalation Study of BAX69 in Subjects With Malignant Ascites of Ovarian Cancer

Refractory Ovarian Cancer With Recurrent Symptomatic Malignant Ascites

United States
Baxalta now part of Shire

Active, not recruiting

A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A

Hemophilia A

Spain, Thailand, Hungary, Taiwan, Korea, Republic of, Czechia, Germany, Sweden, Italy, Croatia, United States, Bulgaria, Netherlands
Baxalta now part of Shire

Completed

GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study

Alpha1-antitrypsin Deficiency

United States, Canada
Baxalta now part of Shire

Completed

Study of Pharmacokinetics, Efficacy and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients - A Continuation of Clinical Study 069901

Hemophilia A

United States, France, Austria, United Kingdom, Germany, Belgium, Canada, Italy, Sweden
Baxalta now part of Shire

Completed

Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A

Hemophilia A

United States
Baxalta now part of Shire

Terminated

Aralast alpha1-proteinase Inhibitor Surveillance Study

Alpha1-antitrypsin Deficiency

United States
Baxalta now part of Shire

Terminated

Phase 2a Study of BAX69 and 5-FU/Leucovorin or Panitumumab Versus Standard of Care in Subjects With Metastatic Colorectal Cancer

Metastatic Colorectal Cancer

United States

Clinical Trials Sponsored by Baxalta Innovations GmbH, now part of Shire

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