HYQVIA

BIOLOGICAL12 trials

Sponsors

Baxalta now part of Shire, Johannes Jakobsen, GWT-TUD GmbH, Thomas Jefferson University, Takeda

Conditions

Chronic Inflammatory Demyelinating PolyradiculoneuropathyChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Healthy VolunteersMultifocal Motor NeuropathyPrimary ImmunodeficiencyPrimary Immunodeficiency Diseases (PID)Secondary Immune DeficiencyStiff-Person Syndrome

Phase 1

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

CompletedNCT04578535

Baxalta now part of ShireHealthy Volunteers

Start: 2020-10-27End: 2022-03-02Updated: 2023-12-14

A Study of TAK-881 and HyQvia in Healthy Adults

CompletedNCT06895967

TakedaHealthy Volunteers

Start: 2025-03-24End: 2025-07-24Updated: 2025-08-19

Phase 2

Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)

CompletedNCT02556437

Johannes JakobsenMultifocal Motor Neuropathy

Start: 2016-06-30End: 2018-05-31Updated: 2018-05-17

A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases

CompletedNCT05755035

TakedaPrimary Immunodeficiency Diseases (PID)

Start: 2023-10-24End: 2026-01-20Updated: 2026-02-03

Phase 3

A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

CompletedNCT02549170

Baxalta now part of ShireChronic Inflammatory Demyelinating Polyradiculoneuropathy

Start: 2015-12-15End: 2022-02-23Updated: 2023-05-24

Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP

CompletedNCT02955355

Baxalta now part of ShireChronic Inflammatory Demyelinating Polyradiculoneuropathy

Start: 2016-11-14End: 2023-07-04Updated: 2024-08-28

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

CompletedNCT03277313

Baxalta now part of ShirePrimary Immunodeficiency Diseases (PID)

Start: 2017-09-25End: 2022-07-20Updated: 2023-10-23

A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

RecruitingNCT06747351

TakedaChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Start: 2025-05-06End: 2028-06-25Target: 59Updated: 2026-01-20

Phase 4

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

CompletedNCT03116347

Baxalta now part of ShirePrimary Immunodeficiency Diseases (PID)

Start: 2017-05-30End: 2021-01-15Updated: 2023-01-11

Unknown Phase

Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)

CompletedNCT02593188

Baxalta now part of ShirePrimary Immunodeficiency Diseases (PID)

Start: 2015-11-12End: 2021-10-21Updated: 2022-10-18

Facilitated Immunoglobulin Administration Registry and Outcomes Study (FIGARO)

CompletedNCT03054181

GWT-TUD GmbHPrimary Immunodeficiency, Secondary Immune Deficiency

Start: 2016-12-22End: 2021-11-30Updated: 2023-09-14

Efficacy and Mechanism of Action of SCIg in Patients With Stiff Person Syndrome (SPS)

Thomas Jefferson UniversityStiff-Person Syndrome

Start: 2019-06-30End: 2020-05-31Target: 22Updated: 2019-05-14

Related Papers

Efficacy, Safety, Tolerability, and Serum IgG Trough Levels of Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 10% in US Pediatric Patients with Primary Immunodeficiency Diseases.

2025-03-141 citations

Long‐term safety and tolerability of hyaluronidase‐facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: Results from the ADVANCE‐CIDP 3 trial

Journal of the Peripheral Nervous System2024-11-115 citations

fSCIG 10% in pediatric primary immunodeficiency diseases: a European post-authorization safety study

Allergy Asthma and Clinical Immunology2024-09-171 citations

Long-Term Safety of Facilitated Subcutaneous Immunoglobulin 10% Treatment in US Clinical Practice in Patients with Primary Immunodeficiency Diseases: Results from a Post-Authorization Safety Study.

2024-08-192 citations

Tolerability and Safety of Large-Volume Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 10% Administered with or without Dose Ramp-Up: A Phase 1 Study in Healthy Participants.

2024-06-192 citations

Patient-reported Outcomes with Hyaluronidase-facilitated Subcutaneous Immunoglobulin 10% Maintenance Therapy for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (P9-11.002)

Neurology2024-04-09

Feasibility Assessment of Facilitated Subcutaneous Immunoglobulin 1.0 G/Kg with Abbreviated Dose Ramp-Up and without Ramp-Up: A Phase 1 Tolerability and Safety Study in Healthy Adults (P6-4.003)

Neurology2023-04-25

Facilitated Subcutaneous Immunoglobulin Treatment in Patients with Immunodeficiencies: the FIGARO Study.

2023-04-1014 citations

P1611: INSIGHTS INTO FACILITATED IMMUNOGLOBULIN (FSCIG) USE IN PATIENTS WITH SECONDARY IMMUNODEFICIENCY DISEASES: FINAL RESULTS FROM THE FIGARO STUDY

HemaSphere2022-06-011 citations

FACILITATED IMMUNOGLOBULIN (FSCIG) USE IN PATIENTS WITH SECONDARY IMMUNODEFICIENCY DISEASES: TWO‐YEAR INTERIM RESULTS FROM THE FIGARO STUDY

Hematological Oncology2021-06-01

Rationale and Design of a Phase 3b Study of the Long-Term Tolerability and Safety of HyQvia in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP): ADVANCE-CIDP 3 (4331)

Neurology2020-04-141 citations