Clinical trial • Phase III • Immunology
HUMAN NORMAL IMMUNOGLOBULIN; HYALURONIDASE (HUMAN RECOMBINANT) for Primary immunodeficiency diseases
Phase III trial of HUMAN NORMAL IMMUNOGLOBULIN; HYALURONIDASE (HUMAN RECOMBINANT) for Primary immunodeficiency diseases. 20 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Primary immunodeficiency diseases
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 06-11-2023
- First CTIS Authorization Date
- 11-03-2024
Trial design
Phase III trial in Germany, Netherlands, Denmark and others.
- Target Sample Size
- 20
Eligibility
Recruits 20 paediatric patients.
- Pregnancy Exclusion
- Subject is pregnant or lactating at the time of screening or intends to become pregnant or begin lactating during the study.
- Vulnerable Population
- Minors are included. The protocol requires that the subject or, in the case of minors, legally designated representative(s) provide informed consent/assent prior to any study procedures; assent and parental/legally designated representative consent procedures are described and age-specific assent/parental ICF documents are provided (multiple assent/parental ICF templates for different minor age groups are included among the study documents).
Inclusion criteria
- {"criterion_text":"- Has completed Study TAK-881-3001.\n- Subject or, in the case of minors, legally designated representative(s) is/are willing and able to comply with the requirements of the protocol.\n- The subject or, in the case of minors, legally designated representative(s) has/have provided informed consent/assent (if applicable), including providing consent for use of the investigational medicinal device (in US sites only), prior to the initiation of any study procedures."}
Exclusion criteria
- {"criterion_text":"- Subject has a serious medical condition such that the subject’s safety or medical care would be impacted by participation in this long-term follow-up study.\n- New medical condition that developed during participation in Study TAK-881-3001 that, in the judgment of the investigator, could increase risk to the subject or interfere with the evaluation of TAK-881 and/or conduct of the study.\n- Subject was enrolled in another clinical study involving an IP or investigational device within 30 days prior to screening (with the exception of Study TAK-881-3001).\n- Subject is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.\n- Subject is a family member or employee of the investigator or the investigator’s site staff.\n- Subjects with potential to become pregnant who meet any one of the following criteria: a. Subject has a positive pregnancy test. b. Subject does not agree to employ a highly effective form of contraception for the duration of the study.\n- Subject is pregnant or lactating at the time of screening or intends to become pregnant or begin lactating during the study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Occurrence of TEAEs.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Occurrence of infusion withdrawals, interruptions, and infusion rate reductions due to TAK-881-related TEAEs.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Efficacy • Annualized rate of all infections. • Annualized rate of ASBIs. • Annualized rate of episodes of fever. • Time to first ASBI. • Duration of infections.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Immunogenicity • Occurrence of positive binding (defined as titer ≥1:160) and neutralizing antibodies to rHuPH20.","definition_or_measurement_approach":"Occurrence of positive binding is defined as titer ≥1:160; neutralizing antibodies also assessed (as specified)."}
- {"endpoint_text":"- Pharmacokinetics • Trough level of total IgG.","definition_or_measurement_approach":"Measurement of trough total IgG levels."}
- {"endpoint_text":"- Treatment regimen • Dose of TAK-881. • Treatment interval of TAK-881.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Infusion parameters: • Number of infusions per month. • Number of infusion sites (needle sticks) per month. • Number of infusion sites (needle sticks) per infusion. • Duration of infusions (minutes). • Monthly infusion time (minutes/month). • Maximum tolerated infusion rate per site (mL/hour/site). • Infusion volume per site (mL/site). • Physical location of infusion (site/infusion center or home). • Subject, caregiver, or healthcare professional (HCP) administration of IP.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Subject satisfaction • Subject satisfaction evaluated by subject-reported scores on the Treatment Satisfaction Questionnaire for Medication (TSQM) - 9 items (TSQM-9).","definition_or_measurement_approach":"Assessed by TSQM-9 patient-reported instrument."}
- {"endpoint_text":"- Health-related quality of life • Subject HRQoL evaluated via EQ-5D-5L.","definition_or_measurement_approach":"Assessed using the EQ-5D-5L questionnaire."}
- {"endpoint_text":"- Treatment preferences • Treatment preferences measured by a disease-specific questionnaire.","definition_or_measurement_approach":"Disease-specific questionnaire as specified in protocol."}
- {"endpoint_text":"- Healthcare resource utilization • Days not able to go to school, work, daycare or to perform normal daily activities due to infections and/or their treatment or other illnesses. • Days on antibiotics. • Number of hospitalizations, indication for the hospitalization (infection or other illnesses) and days hospitalized. • Number of acute physician visits due to infection or other illnesses.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Infusion preparation • HCP-measured time of infusion preparation per guidelines in the Pharmacy Manual/Site Infusion Manual. • Subject/caregiver measured time of infusion preparation per guidelines in the Subject Infusion Manual.","definition_or_measurement_approach":"Time measured by HCP and by subject/caregiver following specified manuals."}
Recruitment
- Planned Sample Size
- 20
- Recruitment Window Months
- 46
- Consent Approach
- Informed consent must be provided by the subject or, for minors, by legally designated representative(s) prior to any study procedures; assent is required for minors where applicable. Consent includes, for US sites only, consent for use of the investigational medical device. Age-specific assent and parental/legal representative ICFs are provided (multiple templates for different minor age ranges and language versions are included).
Methods
- Recruitment materials and arrangements provided (documents listed: ConneX Travel Contact Card/Reference Guide, ClinCard materials, Study Passport, Welcome-Visit Guide, Study Journey Poster, ClinCard Fee Schedule).
- K1/K2 recruitment and ICF process documents (patient recruitment procedure and ICF process) are provided for site-level recruitment.
- Recruitment focused on participants who have completed Study TAK-881-3001 (inclusion criterion).
- Site-based recruitment through participating hospitals/clinics (documents reference site Welcome-Visit Guide and Study Passport).
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 17
Germany
- Earliest CTIS Part Ii Submission Date
- 12-02-2024
- Latest Decision Or Authorization Date
- 12-03-2024
- Processing Time Days
- 29
- Number Of Sites
- 2
- Number Of Participants
- 1
Sites
- Site Name
- Technische Universitat Dresden
- Department Name
- Klinik und Poliklinik für Kinder- und Jugendmedizin am Uniklinikum
- Principal Investigator Name
- Catharina Schuetz
- Principal Investigator Email
- catharina.schuetz@uniklinikum-dresden.de
- Contact Person Name
- Catharina Schuetz
- Contact Person Email
- catharina.schuetz@uniklinikum-dresden.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Klinik für Kinder- und Jugendmedizin
- Principal Investigator Name
- Ursula Holzer
- Principal Investigator Email
- ursula.holzer@med.uni-tuebingen.de
- Contact Person Name
- Ursula Holzer
- Contact Person Email
- ursula.holzer@med.uni-tuebingen.de
Netherlands
- Earliest CTIS Part Ii Submission Date
- 05-03-2024
- Latest Decision Or Authorization Date
- 15-03-2024
- Processing Time Days
- 10
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Stichting Radboud University Medical Center
- Department Name
- Department of Internal Medicine
- Principal Investigator Name
- Frank van der Veerdonk
- Principal Investigator Email
- researchunit.aig@radboudumc.nl
- Contact Person Name
- Frank van der Veerdonk
- Contact Person Email
- researchunit.aig@radboudumc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Rheumatology & Clinical Immunology,
- Principal Investigator Name
- Helen Leavis
- Principal Investigator Email
- h.leavis@umcutrecht.nl
- Contact Person Name
- Helen Leavis
- Contact Person Email
- h.leavis@umcutrecht.nl
Denmark
- Earliest CTIS Part Ii Submission Date
- 23-02-2024
- Latest Decision Or Authorization Date
- 12-03-2024
- Processing Time Days
- 18
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Aarhus Universitetshospital
- Department Name
- Department of Infectious Diseases
- Principal Investigator Name
- Carsten Larsen
- Principal Investigator Email
- carsten.schade.larsen@vest.rm.dk
- Contact Person Name
- Carsten Larsen
- Contact Person Email
- carsten.schade.larsen@vest.rm.dk
Greece
- Earliest CTIS Part Ii Submission Date
- 21-11-2023
- Latest Decision Or Authorization Date
- 14-03-2024
- Processing Time Days
- 114
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- General Hospital Of Thessaloniki Papageorgiou
- Department Name
- 4th Pediatric Clinic
- Principal Investigator Name
- Despoina Tramma
- Principal Investigator Email
- dtramma@auth.gr
- Contact Person Name
- Despoina Tramma
- Contact Person Email
- dtramma@auth.gr
Poland
- Earliest CTIS Part Ii Submission Date
- 07-03-2024
- Latest Decision Or Authorization Date
- 15-03-2024
- Processing Time Days
- 8
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- Site Name
- Instytut Pomnik Centrum Zdrowia Dziecka
- Department Name
- Klinika Immunologii
- Principal Investigator Name
- Małgorzata Pac
- Principal Investigator Email
- m.pac@ipczd.pl
- Contact Person Name
- Małgorzata Pac
- Contact Person Email
- m.pac@ipczd.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Pediatrii, Hematologii i Onkologii Oddzial Szybkiej Diagnostyki z Oddzialem Dziennym
- Principal Investigator Name
- Magdalena Malanowska
- Principal Investigator Email
- magdalena.malanowska@gumed.edu.pl
- Contact Person Name
- Magdalena Malanowska
- Contact Person Email
- magdalena.malanowska@gumed.edu.pl
- Site Name
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Department Name
- Centralny Szpital Kliniczny MON, Klinika Chorob Wew., Pneumonologii, Alergol. i Immunolo. Klinicznej
- Principal Investigator Name
- Ewa Więsik-Szewczyk
- Principal Investigator Email
- ewiesik-szewczyk@wim.mil.pl
- Contact Person Name
- Ewa Więsik-Szewczyk
- Contact Person Email
- ewiesik-szewczyk@wim.mil.pl
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Osr. Ped. im. dr. Korczaka w Lodzi Odd. Alergo. i Inter. Dzie. – Odd. Klinicz. Inter. Dzie. i Alergo
- Principal Investigator Name
- Agnieszka Brzozowska
- Principal Investigator Email
- alergol@kopernik.lodz.pl
- Contact Person Name
- Agnieszka Brzozowska
- Contact Person Email
- alergol@kopernik.lodz.pl
Slovakia
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 11-03-2024
- Processing Time Days
- 26
- Number Of Sites
- 3
- Number Of Participants
- 2
Sites
- Site Name
- Narodny Ustav Detskych Chorob
- Department Name
- Detska klinika LFUK a NUDCH
- Principal Investigator Name
- Peter Ciznar
- Principal Investigator Email
- Peter.Ciznar@nudch.eu
- Contact Person Name
- Peter Ciznar
- Contact Person Email
- Peter.Ciznar@nudch.eu
- Site Name
- OKIA s.r.o.
- Department Name
- Ambulancia klinickej imunologie a alergologie
- Principal Investigator Name
- Stefan Raffac
- Principal Investigator Email
- stevoraffac@gmail.com
- Contact Person Name
- Stefan Raffac
- Contact Person Email
- stevoraffac@gmail.com
- Site Name
- Univerzitna Nemocnica Martin
- Department Name
- Oddelenie klinickej imunologie a alergologie
- Principal Investigator Name
- Milos Jesenak
- Principal Investigator Email
- jesenak@gmail.com
- Contact Person Name
- Milos Jesenak
- Contact Person Email
- jesenak@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 07-03-2024
- Latest Decision Or Authorization Date
- 11-03-2024
- Processing Time Days
- 4
- Number Of Sites
- 4
- Number Of Participants
- 2
Sites
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Infectious diseases service
- Principal Investigator Name
- Celia Guadalupe Cardozo Espinola
- Principal Investigator Email
- CGCARDOZ@clinic.cat
- Contact Person Name
- Celia Guadalupe Cardozo Espinola
- Contact Person Email
- CGCARDOZ@clinic.cat
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Hematology Service
- Principal Investigator Name
- Ana Andrés Martin
- Principal Investigator Email
- aandresm@salud.madrid.org
- Contact Person Name
- Ana Andrés Martin
- Contact Person Email
- aandresm@salud.madrid.org
- Site Name
- Sant Joan De Deu Barcelona Hospital
- Department Name
- Pediatric Allergy and Clinical Immunology Department
- Principal Investigator Name
- Laia Alsina Manrique de Lara
- Principal Investigator Email
- laia.alsina@sjd.es
- Contact Person Name
- Laia Alsina Manrique de Lara
- Contact Person Email
- laia.alsina@sjd.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- Clinical Immunology Service
- Principal Investigator Name
- Eduardo Lopez Granados
- Principal Investigator Email
- elgranados@salud.madrid.org
- Contact Person Name
- Eduardo Lopez Granados
- Contact Person Email
- elgranados@salud.madrid.org
Czechia
- Earliest CTIS Part Ii Submission Date
- 16-02-2024
- Latest Decision Or Authorization Date
- 13-03-2024
- Processing Time Days
- 26
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Fakultni Nemocnice Motol A Homolka
- Department Name
- Ústav imunologie
- Principal Investigator Name
- Anna Šedivá
- Principal Investigator Email
- Anna.sediva@fnmotol.cz
- Contact Person Name
- Anna Šedivá
- Contact Person Email
- Anna.sediva@fnmotol.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Pediatricka klinika
- Principal Investigator Name
- Helena Schneiderova
- Principal Investigator Email
- schneiderova.helena@fnbrno.cz
- Contact Person Name
- Helena Schneiderova
- Contact Person Email
- schneiderova.helena@fnbrno.cz
Sponsor
Primary sponsor
- Full Name
- Takeda Development Center Americas Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Multiple sponsor duties including study management and operational tasks (codes listed in sponsor duties; includes 'Medicinal product management (site level); Home treatment; Patient reimbursement; Ancilliary Supplies').
- Name
- PRA Hellas CRO A.E.
- Responsibilities
- Study start up, contract negotiation and monitoring activities in Greece.
Third parties
- {"country":"United States","full_name":"Eurofins Pharma Bioanalytics Services US Inc.","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"[{\"code\":\"1\"},{\"code\":\"11\"},{\"code\":\"12\"},{\"code\":\"13\"},{\"code\":\"14\"},{\"code\":\"15\",\"value\":\"Medicinal product management (site level); Home treatment; Patient reimbursement; Ancilliary Supplies\"},{\"code\":\"2\"},{\"code\":\"5\"},{\"code\":\"6\"},{\"code\":\"7\"},{\"code\":\"8\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"Clinigen Clinical Supplies Management","duties_or_roles":"[{\"code\":\"15\",\"value\":\"IP management (study)\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Clinigen Clinical Supplies Management GmbH","duties_or_roles":"[{\"code\":\"15\",\"value\":\"IP management (study)\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"[{\"code\":\"15\",\"value\":\"Study start up, contract negotiation and monitoring activities in Greece.\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"[{\"code\":\"15\",\"value\":\"Electronic Clinical Outcome Assessments\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"[{\"code\":\"3\"}]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Marken LLP","duties_or_roles":"[{\"code\":\"15\",\"value\":\"Direct to Patient (DTP) and Direct from Patient (DFP) IP shipment\"}]","organisation_type":"Pharmaceutical company"}
Co-sponsors
- Baxalta Innovations GmbH
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
- Authorised
- Maximum Dose
- 120 g (max daily dose amount as listed)
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