Clinical trial • Phase III • Immunology|Rare Disease

Human normal immunoglobulin; Hyaluronidase (human recombinant) for Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

Phase III trial of Human normal immunoglobulin; Hyaluronidase (human recombinant) for Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

Overview

Trial Therapeutic Area
Immunology|Rare Disease
Trial Disease
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
10-02-2025
First CTIS Authorization Date
02-06-2025

Trial design

open-label, hyqvia 100 mg/ml solution for infusion for subcutaneous use (human normal immunoglobulin) — comparator product listed; dose/schedule not specified in the ctis record.-controlled Phase III trial in Denmark, Czechia, Sweden and others.

Open Label
Yes
Comparator
HyQvia 100 mg/mL solution for infusion for subcutaneous use (human normal immunoglobulin) — comparator product listed; dose/schedule not specified in the CTIS record.
Target Sample Size
19

Eligibility

Recruits 19 Vulnerable population is selected. Participants must be adults (≥18 years) and provide written informed consent documented via a signed and dated ICF prior to any trial procedures. Specific ICF documents are provided (including a pregnant participant ICF and multiple ICF versions); assent is not applicable because minors are excluded..

Pregnancy Exclusion
22. If female, the participant is pregnant or lactating at the time of screening
Vulnerable Population
Vulnerable population is selected. Participants must be adults (≥18 years) and provide written informed consent documented via a signed and dated ICF prior to any trial procedures. Specific ICF documents are provided (including a pregnant participant ICF and multiple ICF versions); assent is not applicable because minors are excluded.

Inclusion criteria

  • {"criterion_text":"- 01. The participant is willing and able to understand and fully comply with trial procedures and requirements, in the opinion of the investigator."}
  • {"criterion_text":"- 02. The participant has provided informed consent (that is, in writing, documented via a signed and dated ICF) and any required privacy authorization before the initiation of any trial procedures."}
  • {"criterion_text":"- 03. The participant is at least 18 years of age at the time of signing the ICF."}
  • {"criterion_text":"- 04. The participant has a documented diagnosis of CIDP or possible CIDP, as confirmed by a neurologist specializing/experienced in neuromuscular diseases and consistent with the EAN/PNS 2021 criteria (Van den Bergh et al., 2021)."}
  • {"criterion_text":"- 05. The participant has responded to IgG treatment in the past (documented partial or complete resolution of neurological symptoms and deficits)."}
  • {"criterion_text":"- 06. The participant is on a stable, pretrial treatment with IGIV, cIGSC, or HYQVIA (also known as TAK-771 in Japan) within the dose range equivalent to a cumulative monthly IgG dose of 0.4 to 2.4 g/kg body weight (BW) (inclusive) administered for at least 12 weeks before screening. The dosing interval of IGIV treatment must be between 2 and 6 weeks (inclusive). The dosing interval must be weekly or biweekly for cIGSC dosing and ≤6 weeks for HYQVIA dosing. Prior to screening, variations in the dosing interval of up to ±7 days or monthly dose amount of up to ±20% between the participant’s consecutive pretrial IgG infusions are acceptable."}
  • {"criterion_text":"- 07. The participant has an INCAT disability score between 0 and 7 (inclusive). Participants will be eligible if one of the below eligibility criteria are met: a. Screening INCAT disability score of between 3 and 7 inclusive. b. Screening INCAT disability score of 2 (both points are from lower extremities). c. Screening INCAT disability score of 2 (both points are not from lower extremities) AND has at least a score of 2 or greater documented in the medical record before screening. If a score was greater than 2 documented in the medical record before screening at least 2 points must be from lower extremities. d. Screening INCAT disability score of 0 or 1 AND has at least a score of 2 or greater (both from lower extremities) documented in the medical record before screening, at least 2 points must be from lower extremities."}
  • {"criterion_text":"- 08. If a participant has the potential to become pregnant, they must have a negative pregnancy test at screening and agree to employ a highly effective contraceptive measure throughout the course of the trial and for at least 30 days after the last administration of IMP."}

Exclusion criteria

  • {"criterion_text":"- 01. Documented diagnosis of focal, multifocal, distal, or sensory CIDP, or possible focal, multifocal, distal, or sensory CIDP per the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) 2021 criteria (Van den Bergh et al., 2021)."}
  • {"criterion_text":"- 10. The participant has a history or clinical manifestations of chronic kidney disease, or glomerular filtration rate of <30 mL/min/1.73 m2 estimated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Levey et al., 2009) at the time of screening."}
  • {"criterion_text":"- 11. The participant has a history of malignancy with less than 2 years of complete remission before screening, or active malignancy requiring chemotherapy and/or radiotherapy. Note: Participants with adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or stable prostate cancer not requiring treatment are eligible."}
  • {"criterion_text":"- 12. The participant has congestive heart failure (New York Heart Association class III/IV), unstable angina, unstable cardiac arrhythmias, or uncontrolled hypertension (defined as diastolic blood pressure >100 mm Hg and/or systolic blood pressure >160 mm Hg during the screening epoch confirmed on 2 measures >30 minutes apart)."}
  • {"criterion_text":"- 13. The participant has an acquired or inherited thrombophilic disorder, such as protein C deficiency, protein S deficiency, antithrombin deficiency, and primary antiphospholipid antibody syndrome."}
  • {"criterion_text":"- 14. The participant has a history of deep vein thrombosis or arterial thromboembolic events (eg, cerebrovascular accident, pulmonary embolism) within 12 months before screening."}
  • {"criterion_text":"- 15. The participant has any medical condition, laboratory finding, or physical examination finding that precludes participation or with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the participant at undue medical risk."}
  • {"criterion_text":"- 16. Participant has a known history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, SC IGSC immunoglobulin, and/or immune serum globulin infusions."}
  • {"criterion_text":"- 17. The participant has a known systemic hypersensitivity to any of the excipients of TAK-881/HYQVIA in accordance with the IB/package insert/Summary of Product Characteristics (SmPC)."}
  • {"criterion_text":"- 18. Participant has a known systemic hypersensitivity to hyaluronidase or rHuPH20."}
  • {"criterion_text":"- 19. The participant has a known history of positive result for or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for hepatitis C virus (HCV), PCR for HIV Type 1 and Type 2. Note: Cured participants with a history of hepatitis C infection who have a negative PCR test at screening are eligible."}
  • {"criterion_text":"- 02. The participant has any neuropathy of other causes, including: a. Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy (HSMN), Charcot-Marie-Tooth (CMT) disease, and hereditary sensory and autonomic neuropathies (HSANs). b. Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria, systemic lupus erythematosus, POEMS (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes) syndrome, osteosclerotic myeloma, diabetic and non-diabetic lumbosacral radiculoplexus neuropathy, lymphoma, amyloidosis. c. Multifocal motor neuropathy (MMN). d. Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy."}
  • {"criterion_text":"- 20. The participant has clinically significant anemia that precludes repeated blood sampling during the trial, or hemoglobin level of <10.0 g/dL at the time of screening. Note: If in investigator judgement, the screening laboratory abnormalities are likely to be transient, then laboratory tests may be repeated. The investigator rationale is to be documented. Laboratory values can be retested once during screening as long as the participant can be evaluated for eligibility and can be enrolled within the allowed screening epoch."}
  • {"criterion_text":"- 21. The participant has any of the following laboratory values at screening: a. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5 × upper limit of normal (ULN). b. Platelet count <100,000 cells/μL. c. Absolute neutrophil count <1000 cells/μL. Note: If in investigator judgement, the screening laboratory abnormalities are likely to be transient, then laboratory tests may be repeated. The investigator rationale is to be documented. Laboratory values can be retested once during screening as long as the participant can be evaluated for eligibility and can be enrolled within the allowed screening epoch."}
  • {"criterion_text":"- 22. If female, the participant is pregnant or lactating at the time of screening"}
  • {"criterion_text":"- 23. The participant has participated in another clinical trial involving an IMP or investigational device within 12 weeks or 5◦half-lives, whichever is longer, before enrollment (except for participants rolling over from the Japan study TAK-771-3002) or is scheduled to participate in another clinical trial involving an IMP or investigational device during the course of this trial."}
  • {"criterion_text":"- 24. The participant is a trial site employee, an immediate family member (eg, spouse, parent, child, sibling), or is in a dependent relationship with a trial site employee who is involved in conduct of this trial, or may consent under duress."}
  • {"criterion_text":"- 03. The participant has any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or which may interfere with assessment of CIDP or outcome measures, including (but not limited to) multiple sclerosis, arthritis, stroke, Parkinson’s disease, and diabetic peripheral neuropathy. Note: Participants with clinically diagnosed diabetes mellitus who do not have diabetic peripheral neuropathy and who have adequate glycemic control with hemoglobin A1c [HbA1c] level of <7.5% at screening will be eligible for the trial, provided the electrodiagnostic criteria are consistent with the diagnosis of CIDP or possible CIDP consistent with the EFNS/PNS 2021 criteria and the participant agrees to maintain adequate glycemic control."}
  • {"criterion_text":"- 04. The participant is required to take or has taken immunomodulatory/immunosuppressive agents (except IGIV, cIGSC, or fIGSC) that include but are not limited to specific complement inhibitors, rituximab, neonatal Fc receptor inhibitors (eg, efgartigimod), and chemotherapeutic drugs, within 6 months of screening. Participants on a long-term, stable dosing regimen of certain immunomodulatory agents (eg, hydroxychloroquine) for the treatment of non-CIDP conditions may be included in the trial."}
  • {"criterion_text":"- 05. The participant is required to take or has taken long-term systemic corticosteroids defined as dosages >20 mg/day prednisone-equivalent for >30 days within 3 months of screening. Note: Participants using short-pulse dose corticosteroid course and oral daily corticosteroids ≤20 mg/day prednisone-equivalent are allowed."}
  • {"criterion_text":"- 06. The participant has undergone plasma exchange within 3 months before screening."}
  • {"criterion_text":"- 07. The participant has immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with a high titer of antibody to myelin-associated glycoprotein."}
  • {"criterion_text":"- 08. The participant has immunoglobulin A (IgA) deficiency (IgA <0.07 g/L) associated with known anti-IgA antibodies and a history of hypersensitivity to human immunoglobulin treatment."}
  • {"criterion_text":"- 09. The participant has a condition(s) which could alter protein catabolism and/or IgG use (eg, protein losing enteropathies, and nephrotic syndrome)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 01. Baseline-uncorrected area under the curve during the dosing interval at steady-state (AUC0-τ,ss) based on total IgG levels.","definition_or_measurement_approach":"AUC0-τ,ss measured using total IgG levels at steady-state during the dosing interval (baseline-uncorrected), i.e., pharmacokinetic AUC over the dosing interval based on total IgG."}

Recruitment

Digital Remote Recruitment
True — digital channels explicitly listed in documents include website materials and video; recruitment materials include website and video documents.
Planned Sample Size
19
Recruitment Window Months
59
Consent Approach
Written informed consent is required: 'in writing, documented via a signed and dated ICF' prior to any trial procedures. Participants must be ≥18 years and provide their own consent. Multiple ICF documents are provided (including a main ICF and a pregnant participant ICF); translated titles and protocol translations indicate materials are available in multiple languages (e.g., Spanish, Greek, Polish).

Methods

  • HCP Flyer – healthcare professional outreach (document titles such as 'K2_HCP Flyer_FP')
  • Patient Letter – mailed or emailed letters to potential participants ('K2_Patient Letter_FP')
  • Patient Flyer / Patient Brochure – printed recruitment materials for patients ('K2_Patient Flyer_FP', 'K2_Patient Brochure_FP')
  • Website listings / Online materials – recruitment via website and online content ('K2_Website_FP')
  • Video – informational video materials for recruitment ('K2_Video_FP')
  • HCP Letter – directed letters to HCPs ('K2_HCP Letter_FP')
  • Advocacy Materials – materials intended for advocacy group engagement ('K2_Advocacy Materials_FP')
  • GP letter / Welcome and Procedure Guides / Participant training scripts – local site communications and participant guides (document titles indicate use)

Geography

Total Number Of Sites
25
Total Number Of Participants
46

Denmark

Earliest CTIS Part Ii Submission Date
21-05-2025
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
299
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Rigshospitalet
Department Name
Copenhagen Neuromuscular Center, Clinical Trials, Section 8077
Principal Investigator Name
Tina Dysgaard
Principal Investigator Email
tina.dysgaard@regionh.dk
Contact Person Name
Tina Dysgaard
Contact Person Email
tina.dysgaard@regionh.dk
Site Name
Aarhus University Hospital
Department Name
Department of Neurology
Principal Investigator Name
Lars Markvardsen
Principal Investigator Email
larsmark@rm.dk
Contact Person Name
Lars Markvardsen
Contact Person Email
larsmark@rm.dk

Czechia

Earliest CTIS Part Ii Submission Date
06-05-2025
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
315
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Neurologická klinika
Principal Investigator Name
Pavel Kunc
Principal Investigator Email
pavel.kunc@fnhk.cz
Contact Person Name
Pavel Kunc
Contact Person Email
pavel.kunc@fnhk.cz

Sweden

Earliest CTIS Part Ii Submission Date
06-05-2025
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
315
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
MS Centrum Forskningsenhet
Principal Investigator Name
Lenka Nováková Nyrén
Contact Person Name
Lenka Nováková Nyrén

Poland

Earliest CTIS Part Ii Submission Date
15-05-2025
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
312
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Clinirem Sp. z o.o.
Principal Investigator Name
Urszula Chyrchel-Paszkiewicz
Principal Investigator Email
pgluchyrchel@gmail.com
Contact Person Name
Urszula Chyrchel-Paszkiewicz
Contact Person Email
pgluchyrchel@gmail.com
Site Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name
Centralny Szpital Kliniczny, Klinika Neurologii
Principal Investigator Name
Anna Kostera-Pruszczyk
Principal Investigator Email
neurologia1-sekretariat@wum.edu.pl
Contact Person Name
Anna Kostera-Pruszczyk
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddział Kliniczny Neurologii
Principal Investigator Name
Agnieszka Słowik
Principal Investigator Email
neurologiabk@su.krakow.pl
Contact Person Name
Agnieszka Słowik
Contact Person Email
neurologiabk@su.krakow.pl

Greece

Earliest CTIS Part Ii Submission Date
13-08-2025
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
218
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
General University Hospital Of Patras
Department Name
Neurology Department
Principal Investigator Name
Chroni Elisabeth
Principal Investigator Email
echroni@upatras.gr
Contact Person Name
Chroni Elisabeth
Contact Person Email
echroni@upatras.gr
Site Name
University General Hospital Attikon
Department Name
B’ Clinic of Neurology
Principal Investigator Name
Georgios Tsivgoulis
Principal Investigator Email
tsivgoulisgiorg@yahoo.gr
Contact Person Name
Georgios Tsivgoulis
Contact Person Email
tsivgoulisgiorg@yahoo.gr

Spain

Earliest CTIS Part Ii Submission Date
07-08-2025
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
224
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Neurology service
Principal Investigator Name
Luis Antonio Querol Gutierrez
Principal Investigator Email
m.teresa.sevilla@uv.es
Contact Person Name
Luis Antonio Querol Gutierrez
Contact Person Email
m.teresa.sevilla@uv.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Neurology service
Principal Investigator Name
Maria Teresa Sevilla Mantecón
Principal Investigator Email
LQuerol@santpau.cat
Contact Person Name
Maria Teresa Sevilla Mantecón
Contact Person Email
LQuerol@santpau.cat

Germany

Earliest CTIS Part Ii Submission Date
02-05-2025
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
319
Number Of Sites
5
Number Of Participants
9

Sites

Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
Neurology
Principal Investigator Name
Hans-Werner Rausch
Principal Investigator Email
hans-werner.rausch@medma.uni-heidelberg.de
Contact Person Name
Hans-Werner Rausch
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Clinic for Neurology, CBF
Principal Investigator Name
Fabian Klostermann
Principal Investigator Email
fabian.klostermann@charite.de
Contact Person Name
Fabian Klostermann
Contact Person Email
fabian.klostermann@charite.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Department of Neurology
Principal Investigator Name
Angela Rosenbohm
Principal Investigator Email
angela.rosenbohm@uni-ulm.de
Contact Person Name
Angela Rosenbohm
Contact Person Email
angela.rosenbohm@uni-ulm.de
Site Name
Philipps-Universitaet Marburg
Department Name
Department of Neurology
Principal Investigator Name
Clemens Warnke
Principal Investigator Email
clemens.warnke@uni-marburg.de
Contact Person Name
Clemens Warnke
Contact Person Email
clemens.warnke@uni-marburg.de
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Neurologie
Principal Investigator Name
Thomas Skripuletz
Principal Investigator Email
skripuletz.thomas@mh-hannover.de
Contact Person Name
Thomas Skripuletz

Italy

Earliest CTIS Part Ii Submission Date
06-05-2025
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
323
Number Of Sites
9
Number Of Participants
11

Sites

Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO Neurologia
Principal Investigator Name
Giulia Ricci
Principal Investigator Email
giulia.ricci@med.unipi.it
Contact Person Name
Giulia Ricci
Contact Person Email
giulia.ricci@med.unipi.it
Site Name
IRCCS Azienda Ospedaliera Metropolitana
Department Name
Clinica Neurologica Largo Daneo, 3 - 16132 Genova, Italy
Principal Investigator Name
Chiara Gemelli
Principal Investigator Email
chiara.gemelli@hsanmartino.it
Contact Person Name
Chiara Gemelli
Contact Person Email
chiara.gemelli@hsanmartino.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
U.O.C. Neurologia e Malattie Neuromuscolari
Principal Investigator Name
Luca Gentile
Principal Investigator Email
luca.gentile@unime.it
Contact Person Name
Luca Gentile
Contact Person Email
luca.gentile@unime.it
Site Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Department Name
U.O. Neuroncologia
Principal Investigator Name
Enrico Marchioni
Principal Investigator Email
enrico.marchioni@mondino.it
Contact Person Name
Enrico Marchioni
Contact Person Email
enrico.marchioni@mondino.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Malattie Neurologiche, Neuromuscolari e Distrofie Miotoniche Rare-Area Neuropatie Immuno-mediate
Principal Investigator Name
Girolama Alessandra Marfia
Principal Investigator Email
marfia@uniroma2.it
Contact Person Name
Girolama Alessandra Marfia
Contact Person Email
marfia@uniroma2.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
UO Neurologia
Principal Investigator Name
Stefano Carlo Previtali
Principal Investigator Email
previtali.stefano@hsr.it
Contact Person Name
Stefano Carlo Previtali
Contact Person Email
previtali.stefano@hsr.it
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
S.S.D. Patologie Neurologiche Specialistiche
Principal Investigator Name
Marinella Clerico
Principal Investigator Email
marinella.clerico@unito.it
Contact Person Name
Marinella Clerico
Contact Person Email
marinella.clerico@unito.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
UOC Neurologia
Principal Investigator Name
Alessandro Padovani
Principal Investigator Email
alessandro.padovani@unibs.it
Contact Person Name
Alessandro Padovani
Contact Person Email
alessandro.padovani@unibs.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O. Malattie Neuromuscolari e Neuroimmunologia
Principal Investigator Name
Giuseppe Liberatore
Principal Investigator Email
giuseppe.liberatore@humanitas.it
Contact Person Name
Giuseppe Liberatore

Sponsor

Primary sponsor

Full Name
Takeda Development Center Americas Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Development LP
Responsibilities
codes: 4
Name
Icon Clinical Research Limited
Responsibilities
codes: 1,10,11,12,13,5,6,8
Name
Pharmaceutical Product Development LLC
Responsibilities
codes: 4

Third parties

  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Clinigen Clinical Supplies Management GmbH","duties_or_roles":"codes: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"codes: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"Sample Tracking tool (Labmatrix)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Avantor Inc.","duties_or_roles":"ECG Machine & Ancillary Supplies","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA and Rater training; codes: 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Matthews Media Group Inc.","duties_or_roles":"PR&R","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eurofins Pharma Bioanalytics Services US Inc.","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes: 1,10,11,12,13,5,6,8","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Accellacare Limited","duties_or_roles":"In Home Services and Site Resourcing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
TAK-881
Active Substance
Human normal immunoglobulin; Hyaluronidase (human recombinant)
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
SUBCUTANEOUS
Authorisation Status
Investigational (no marketing authorisation number provided in record; prodAuthStatus: 1)
Maximum Dose
120 g (maxDailyDoseAmount as listed)
Investigational Product Name
HyQvia 100 mg/mL solution for infusion for subcutaneous use
Active Substance
Human normal immunoglobulin
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
SUBCUTANEOUS
Authorisation Status
Marketing authorisation: EU/1/13/840/004 (prodAuthStatus: 2)
Maximum Dose
120 g (maxDailyDoseAmount as listed)
Combination Treatment
Yes

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