13 completed, 2 unknown, 1 recruiting. 6 Phase 3, 2 Phase 1, 2 Phase 2, 2 Phase 4, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 5, Recruiting 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 2 | 2 | Completed 2 |
| Phase 4 | 2 | Completed 2 |
| Not applicable | 1 | Unknown 1 |
Follow HYQVIA: new trials by email Literature Review of HYQVIA trials Research Report on HYQVIA
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) TAK-881, HYQVIA, SC Investigational Needle Sets - Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Phase 3 | Recruiting | Takeda | 59 | 2025-05-06 | 2026-01-20 |
| A Study of TAK-881 and HyQvia in Healthy Adults TAK-881, HyQvia, SC Investigational Needle Sets - Healthy Volunteers | Phase 1 | Completed | Takeda | 30 | 2025-03-24 | 2026-06-11 |
| A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases TAK-881, HYQVIA - Primary Immunodeficiency Diseases (PID) | Phase 2 / Phase 3 | Completed | Takeda | 65 | 2023-10-24 | 2026-09-30 |
| 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 HYQVIA - Healthy Volunteers | Phase 1 | Completed | Baxalta now part of Shire | 51 | 2020-10-27 | 2023-12-14 |
| Efficacy and Mechanism of Action of SCIg in Patients With Stiff Person Syndrome (SPS) HyQvia - Stiff-Person Syndrome | Unknown | Thomas Jefferson University | 22 | 2019-06-01 | 2019-05-14 | |
| Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects HYQVIA - Primary Immunodeficiency Diseases (PID) | Phase 3 | Completed | Baxalta now part of Shire | 44 | 2017-09-25 | 2023-10-23 |
| Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects HYQVIA, KIOVIG, Cuvitru - Primary Immunodeficiency Diseases (PID) | Phase 4 | Completed | Baxalta now part of Shire | 42 | 2017-05-30 | 2023-01-11 |
| Facilitated Immunoglobulin Administration Registry and Outcomes Study (FIGARO) HyQvia - Primary Immunodeficiency, Secondary Immune Deficiency | Completed | GWT-TUD GmbH | 156 | 2016-12-22 | 2023-09-14 | |
| Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP HYQVIA - Chronic Inflammatory Demyelinating Polyradiculoneuropathy | Phase 3 | Completed | Baxalta now part of Shire | 85 | 2016-11-14 | 2024-08-28 |
| IgG Level in Primary Immunodeficiency Switching From Standard SCIG to Every Other Week HyQvia IgHy10 - Primary Immunodeficiency | Phase 4 | Completed | University Hospital, Lille | 22 | 2016-11-11 | 2019-06-25 |
| HyQvia in Multifocal Motor Neuropathy rHuPH20 - Multifocal Motor Neuropathy | Not applicable | Unknown | UMC Utrecht | 20 | 2016-09-01 | 2016-08-31 |
| Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN) HyQvia, Subcuvia - Multifocal Motor Neuropathy | Phase 2 | Completed | Johannes Jakobsen | 18 | 2016-06-01 | 2018-05-17 |
| A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) HYQVIA, 0.25% albumin placebo solution with rHuPH20, IGIV GAMMAGARD LIQUID/KIOVIG - Chronic Inflammatory Demyelinating Polyradiculoneuropathy | Phase 3 | Completed | Baxalta now part of Shire | 138 | 2015-12-15 | 2023-05-24 |
| Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment, HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] - Exposure During Pregnancy | Completed | Baxalta now part of Shire | 16 | 2015-12-04 | 2021-04-28 | |
| Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global) HYQVIA - Primary Immunodeficiency Diseases (PID) | Completed | Baxalta now part of Shire | 264 | 2015-11-12 | 2022-10-18 | |
| Gammagard Liquid and rHuPH20 in PID Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV) - Primary Immunodeficiency Diseases (PID) | Phase 3 | Completed | Baxalta now part of Shire | 89 | 2008-12-18 | 2021-05-19 |
Primary Immunodeficiency Diseases (7) · Polyradiculoneuropathy, Chronic Inflammatory Demyelinating (3) · Autoimmune Diseases (1) · Autoimmune Diseases of the Nervous System (1) · Bronchiolitis Obliterans Syndrome (1) · Demyelinating Diseases (1) · Immune System Diseases (1) · Infections (1) · Nervous System Diseases (1) · Neuromuscular Diseases (1) · Peripheral Nervous System Diseases (1) · Polyneuropathies (1) · Polyradiculoneuropathy (1) · Stiff-Person Syndrome (1)
Baxalta now part of Shire (8) · Takeda (3) · GWT-TUD GmbH (1) · Johannes Jakobsen (1) · Thomas Jefferson University (1) · UMC Utrecht (1) · University Hospital, Lille (1)
United States (10) · Czechia (6) · Denmark (6) · Germany (6) · France (5) · Poland (5) · Slovakia (5) · Greece (4) · Italy (4) · Spain (4) · Argentina (3) · Canada (3) · Sweden (3) · United Kingdom (3) · Brazil (2)
David Pittrow, MD (1) · Eric Hachulla, MD, PhD (1) · Isabelle Quinti, MD (1) · Johannes Jakobsen, DMSc (1) · Leif Hanitsch, MD (1) · Leonard van den Berg, prof (1) · Michael Borte, MD, PhD (1) · Nizar Mahlaoui, MD (1)
PMID 42578463, PMID 22846381, PMID 27220317, PMID 34931880, PMID 35443783, PMID 37036560, PMID 39289739, PMID 39523874, PMID 41937917
2016 (3), 2014 (1)