Clinical trial • Phase III • Haematology|Rare Disease
efanesoctocog alfa for Haemophilia A
Phase III trial of efanesoctocog alfa for Haemophilia A. open-label, none/not specified-controlled. 124 participants.
Overview
- Trial Therapeutic Area
- Haematology|Rare Disease
- Trial Disease
- Haemophilia A
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
- Paediatric Trial
- Yes
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 04-12-2023
- First CTIS Authorization Date
- 11-04-2024
Trial design
open-label, none/not specified-controlled Phase III trial in Germany, Slovenia, Netherlands and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 124
Eligibility
Recruits 124 paediatric patients.
- Vulnerable Population
- Parents’ or legally designated representatives’ consent is required for patients who are <18 years of age or unable to give consent, or as applicable per local laws, before any study-related activities are undertaken. Patients who are <18 years of age should provide assent in addition to the parents’/legally designated representatives’ consent, if appropriate.
Inclusion criteria
- {"criterion_text":"- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and protocol. Parents’ or legally designated representatives’ consent is required for patients who are <18 years of age or unable to give consent, or as applicable per local laws, before any study-related activities are undertaken. Patients who are <18 years of age should provide assent in addition to the parents’/legally designated representatives’ consent, if appropriate.\n- Contraceptive use by patients should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Males: No contraceptive measures required for this study.\n- Must have completed one of the required parent studies: LTS16294, Sobi.BIVV001-001, Sobi.BIVV001-003, or Sobi.BIVV001-004, and be receiving a clinical benefit from the efanesoctocog alfa treatment, as judged by the Investigator. The interval between the patient’s last study dose in the parent study and Visit 1 of this study should preferably be within 7 days for the LTS16294, Sobi.BIVV001-001 and Sobi.BIVV001-004 studies to ensure there is no interruption in the prophylaxis dosing with efanesoctocog alfa. Patients coming from the Sobi.BIVV001-003 study, should preferably enter this study at the EoS visit of that study.\n- Willingness and ability of the patient or parent or their legally designated representative to complete training in the use of the study patient diary and to complete the diary throughout the study."}
Exclusion criteria
- {"criterion_text":"- Positive inhibitor result defined as ≥0.6 Bethesda units (BU)/mL, at the Baseline Visit.\n- Ongoing or planned participation in any interventional clinical study at Baseline Visit.\n- Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Safety Endpoint: The occurrence of adverse events (AEs), including serious adverse events (SAEs) and AESIs","definition_or_measurement_approach":"Collection and reporting of adverse events (AEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs) as measures of safety and tolerability."}
- {"endpoint_text":"- Efficacy Endpoints: To collect further data on the efficacy of efanesoctocog alfa as a prophylaxis treatment; To collect further data on the efficacy of efanesoctocog alfa in the treatment of bleeding episodes","definition_or_measurement_approach":"Annualised Bleeding Rate (ABR) for treated bleeds and all bleeds (including untreated bleeds, excluding surgical bleeds) by type and location during prophylactic treatment; number of injections and total dose required to treat a bleeding episode."}
Recruitment
- Planned Sample Size
- 124
- Recruitment Window Months
- 35
- Consent Approach
- Capable of giving signed informed consent is required. Parents’ or legally designated representatives’ consent is required for patients <18 years or unable to give consent; patients <18 years should provide assent in addition to parents'/legally designated representatives' consent where appropriate. Age-specific information/assent and ICF documents are provided (examples in repository include assent forms for 6-11 years, 12-16 years, 14-17 years, parent/holder of parental authority forms and adult ICFs). Consent/ICF materials are available in multiple languages as per submitted documents (examples: English, German, Spanish, Italian, French, Greek, Slovenian, Bulgarian, Dutch, Norwegian, Swedish).
Geography
- Total Number Of Sites
- 32
- Total Number Of Participants
- 124
Germany
- Earliest CTIS Part Ii Submission Date
- 13-03-2024
- Latest Decision Or Authorization Date
- 11-04-2024
- Processing Time Days
- 29
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Institute of Experimental Hematology and Transfusion Medicine
- Principal Investigator Name
- Johannes Oldenburg
- Principal Investigator Email
- johannes.oldenburg@ukbonn.de
- Contact Person Name
- Johannes Oldenburg
- Contact Person Email
- johannes.oldenburg@ukbonn.de
- Site Name
- Universitaetsklinikum Frankfurt AöR
- Department Name
- Hematology
- Principal Investigator Name
- Wolfgang Miesbach
- Principal Investigator Email
- wolfgang.miesbach@kgu.de
- Contact Person Name
- Wolfgang Miesbach
- Contact Person Email
- wolfgang.miesbach@kgu.de
Slovenia
- Earliest CTIS Part Ii Submission Date
- 27-11-2024
- Latest Decision Or Authorization Date
- 26-02-2025
- Processing Time Days
- 91
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- University Medical Center Ljubljana
- Department Name
- Clinical Department of Haematology
- Principal Investigator Name
- Irena Preloznik Zupan
- Principal Investigator Email
- irena.zupan@kclj.si
- Contact Person Name
- Irena Preloznik Zupan
- Contact Person Email
- irena.zupan@kclj.si
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-02-2025
- Latest Decision Or Authorization Date
- 17-03-2025
- Processing Time Days
- 34
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Internal medecine
- Principal Investigator Name
- Paul Van Der Valk
- Principal Investigator Email
- p.r.vandervalk@umcutrecht.nl
- Contact Person Name
- Paul Van Der Valk
- Contact Person Email
- p.r.vandervalk@umcutrecht.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Pediatric Hematology
- Principal Investigator Name
- Karin Fijnvandraat
- Principal Investigator Email
- c.j.fijnvandraat@amsterdamumc.nl
- Contact Person Name
- Karin Fijnvandraat
- Contact Person Email
- c.j.fijnvandraat@amsterdamumc.nl
France
- Earliest CTIS Part Ii Submission Date
- 31-03-2025
- Latest Decision Or Authorization Date
- 07-04-2025
- Processing Time Days
- 7
- Number Of Sites
- 8
- Number Of Participants
- 28
Sites
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Institut Coeur Poumon, Dpartment of Hemostasis and Transfusion
- Principal Investigator Name
- Sophie Susen
- Principal Investigator Email
- sophie.susen@chru-lille.fr
- Contact Person Name
- Sophie Susen
- Contact Person Email
- sophie.susen@chru-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Site Hôpital des Enfants, Competence and Resources Center for Constitutional Hemorrhagic Disorders
- Principal Investigator Name
- Yoann Huguenin
- Principal Investigator Email
- yoann.huguenin@chu-bordeaux.fr
- Contact Person Name
- Yoann Huguenin
- Contact Person Email
- yoann.huguenin@chu-bordeaux.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Site Louis Pradel, Department of Biological Hematology and Clinical Hemostasis
- Principal Investigator Name
- Sandrine Meunier
- Principal Investigator Email
- sandrine.meunier@chu-lyon.fr
- Contact Person Name
- Sandrine Meunier
- Contact Person Email
- sandrine.meunier@chu-lyon.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Site de la Cavale Blanche, Department of Hematology
- Principal Investigator Name
- Brigitte Pan-Petesch
- Principal Investigator Email
- brigitte.pan-petesch@chu-brest.fr
- Contact Person Name
- Brigitte Pan-Petesch
- Contact Person Email
- brigitte.pan-petesch@chu-brest.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Site Hautepierre, Department of Hematology and Oncology
- Principal Investigator Name
- Dominique Desprez Flor
- Principal Investigator Email
- dominique.desprez@chru-strasbourg.fr
- Contact Person Name
- Dominique Desprez Flor
- Contact Person Email
- dominique.desprez@chru-strasbourg.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hôpital Bicêtre, Reference Centre for Haemophilia
- Principal Investigator Name
- Roseline d'Oiron
- Principal Investigator Email
- roseline.doiron@aphp.fr
- Contact Person Name
- Roseline d'Oiron
- Contact Person Email
- roseline.doiron@aphp.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Department of Pediatric Hematology, Immunology and Oncology
- Principal Investigator Name
- Hervé Chambost
- Principal Investigator Email
- herve.chambost@hp-hm.fr
- Contact Person Name
- Hervé Chambost
- Contact Person Email
- herve.chambost@hp-hm.fr
- Site Name
- Centre Hospitalier Regional De Brest (duplicate listing not specified)
- Department Name
- Department of Hematology (example site listings aggregated)
Greece
- Earliest CTIS Part Ii Submission Date
- 27-11-2024
- Latest Decision Or Authorization Date
- 10-03-2025
- Processing Time Days
- 103
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Nosokomeio Paidon I Agia Sofia
- Department Name
- Haemophilia Centre, Haemostasis and Thrombosis Unit
- Principal Investigator Name
- Helen Pergantou
- Principal Investigator Email
- hpergantou@gmail.com
- Contact Person Name
- Helen Pergantou
- Contact Person Email
- hpergantou@gmail.com
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- Blood Transfusion Service and National Reference Centre for Congenital Bleeding Disorders
- Principal Investigator Name
- Olga Katsarou-Fasouli
- Principal Investigator Email
- olgkats@hotmail.com
- Contact Person Name
- Olga Katsarou-Fasouli
- Contact Person Email
- olgkats@hotmail.com
Norway
- Earliest CTIS Part Ii Submission Date
- 12-09-2025
- Latest Decision Or Authorization Date
- 18-09-2025
- Processing Time Days
- 6
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Department of Haematology
- Principal Investigator Name
- Pål Andrè Holme
- Principal Investigator Email
- pholme@ous-hf.no
- Contact Person Name
- Pål Andrè Holme
- Contact Person Email
- pholme@ous-hf.no
Italy
- Earliest CTIS Part Ii Submission Date
- 11-01-2024
- Latest Decision Or Authorization Date
- 15-04-2024
- Processing Time Days
- 95
- Number Of Sites
- 8
- Number Of Participants
- 21
Sites
- Site Name
- Azienda Unita Locale Socio Sanitaria N 8 Berica
- Department Name
- UOC Hematology
- Principal Investigator Name
- Ilaria Nichele
- Principal Investigator Email
- ilaria.nichele@aulss8.veneto.it
- Contact Person Name
- Ilaria Nichele
- Contact Person Email
- ilaria.nichele@aulss8.veneto.it
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- Department of Oncology, SOD Hemorrhagic and Coagulation Diseases
- Principal Investigator Name
- Giancarlo Castaman
- Principal Investigator Email
- castaman@aou-careggi.toscana.it
- Contact Person Name
- Giancarlo Castaman
- Contact Person Email
- castaman@aou-careggi.toscana.it
- Site Name
- Humanitas Research Hospital
- Department Name
- Center for Thrombosis and Hemorrhagic Diseases
- Principal Investigator Name
- Maria Elisa Mancuso
- Principal Investigator Email
- mariaelisa.mancuso@humanitas.it
- Contact Person Name
- Maria Elisa Mancuso
- Contact Person Email
- mariaelisa.mancuso@humanitas.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Department of Clinical Medicine and Surgery
- Principal Investigator Name
- Matteo Di Minno
- Principal Investigator Email
- matteo.diminno@unina.it
- Contact Person Name
- Matteo Di Minno
- Contact Person Email
- matteo.diminno@unina.it
- Site Name
- Azienda Ospedaliero Universitaria Parma
- Department Name
- SSD Hub Center Hemophilia and Congenital Hemorrhagic Diseases
- Principal Investigator Name
- Antonio Coppola
- Principal Investigator Email
- ancoppola@ao.pr.it
- Contact Person Name
- Antonio Coppola
- Contact Person Email
- ancoppola@ao.pr.it
- Site Name
- Azienda Ospedaliero Universitaria Renato Dulbecco
- Department Name
- Department Hemato-Oncology
- Principal Investigator Name
- Rita Carlotta Santoro
- Principal Investigator Email
- ritacarlottasantoro@gmail.com
- Contact Person Name
- Rita Carlotta Santoro
- Contact Person Email
- ritacarlottasantoro@gmail.com
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- Department of Translational and Precision Medicine - Division of Hematology
- Principal Investigator Name
- Cristina Santoro
- Principal Investigator Email
- santoro@bce.uniromal.it
- Contact Person Name
- Cristina Santoro
- Contact Person Email
- santoro@bce.uniromal.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Complex Structure of Medicine Hemostasis and Thrombosis
- Principal Investigator Name
- Flora Peyvandi
- Principal Investigator Email
- Flora.peyvandi@unimi.it
- Contact Person Name
- Flora Peyvandi
- Contact Person Email
- Flora.peyvandi@unimi.it
Spain
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 11-04-2024
- Processing Time Days
- 24
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Hematology
- Principal Investigator Name
- Saturnino Haya Guaita
- Principal Investigator Email
- haya_sat@gva.es
- Contact Person Name
- Saturnino Haya Guaita
- Contact Person Email
- haya_sat@gva.es
- Site Name
- Hospital Unviersitario Miguel Servet
- Department Name
- Hematology
- Principal Investigator Name
- José Manuel Calvo Villas
- Principal Investigator Email
- informacion.sector2@salud.aragon.es
- Contact Person Name
- José Manuel Calvo Villas
- Contact Person Email
- informacion.sector2@salud.aragon.es
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Hematology
- Principal Investigator Name
- Marta Fernandez Docampo
- Principal Investigator Email
- Marta.Fernandez.Docampo@sergas.es
- Contact Person Name
- Marta Fernandez Docampo
- Contact Person Email
- Marta.Fernandez.Docampo@sergas.es
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 07-03-2025
- Latest Decision Or Authorization Date
- 24-03-2025
- Processing Time Days
- 17
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Specialized Hospital For Active Treatment Of Hematological Diseases EAD
- Department Name
- Third Department of Clinical Hematology at Clinical Hematology Clinic
- Principal Investigator Name
- Toshko Lissitchkov
- Principal Investigator Email
- t_lissitchkov@yahoo.com
- Contact Person Name
- Toshko Lissitchkov
- Contact Person Email
- t_lissitchkov@yahoo.com
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Clinical Hematology Clinic
- Principal Investigator Name
- Emil Spasov
- Principal Investigator Email
- dr-espassov@yahoo.com
- Contact Person Name
- Emil Spasov
- Contact Person Email
- dr-espassov@yahoo.com
Sweden
- Earliest CTIS Part Ii Submission Date
- 07-07-2025
- Latest Decision Or Authorization Date
- 29-07-2025
- Processing Time Days
- 22
- Number Of Sites
- 3
- Number Of Participants
- 14
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Department of Haematology and Coagulation Disorders
- Principal Investigator Name
- Fariba Baghaei
- Principal Investigator Email
- fariba.baghaei@vgregion.se
- Contact Person Name
- Fariba Baghaei
- Contact Person Email
- fariba.baghaei@vgregion.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Hematology and Vascular diseases
- Principal Investigator Name
- Jan Astermark
- Principal Investigator Email
- Jan.Astermark@med.lu.se
- Contact Person Name
- Jan Astermark
- Contact Person Email
- Jan.Astermark@med.lu.se
- Site Name
- Karolinska University Hospital
- Department Name
- Department of Haematology
- Principal Investigator Name
- Maria Magnusson
- Principal Investigator Email
- maria.s.magnusson@regionstockholm.se
- Contact Person Name
- Maria Magnusson
- Contact Person Email
- maria.s.magnusson@regionstockholm.se
Sponsor
Primary sponsor
- Full Name
- Swedish Orphan Biovitrum AB (publ)
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Contract research organisations
- Name
- Psi Cro AG
- Responsibilities
- laboratory support; pharmacovigilance; statistics; translations; vendor management (as per contract); additional sponsor duties coded 1,11,12,2,5,6
- Name
- Psi CRO Greece
- Responsibilities
- sponsor duties coded 1 and 12
- Name
- Almac Clinical Services Limited
- Responsibilities
- QP batch release for IMP test; sponsor duties coded 14 and 15
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- sponsor duties coded 3
- Name
- Almac Clinical Services (Ireland) Limited
- Responsibilities
- sponsor duties coded 14
Third parties
- {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"codes:1,11,12,15 (as per contract (laboratory support; pharmacovigilance; statistics, translations; vendor management)),2,5,6","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Psi CRO Greece","duties_or_roles":"codes:1,12","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"code:7","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"codes:14,15 (value: QP batch release for IMP test)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"code:15 (value: Global reimbursement arrangement)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"code:15 (value: Logistics, storage of samples and future potential testing)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Esoterix Inc.","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"Labcorp","duties_or_roles":"codes:15 (Kit building and Logistics),4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- ALTUVOCT 2 000 IU powder and solvent for solution for injection
- Active Substance
- efanesoctocog alfa
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS INJECTION
- Route
- INTRAVENOUS INJECTION
- Authorisation Status
- Marketing authorisation number EU/1/24/1824/005 present
- Orphan Designation
- Yes
- Starting Dose
- 50 IU/kg
- Dose Levels
- 50 IU/kg
- Frequency
- once-weekly
- Maximum Dose
- 50 IU/kg (max daily dose amount listed as 50 IU/kg)
- Investigational Product Name
- ALTUVOCT 3 000 IU powder and solvent for solution for injection
- Active Substance
- efanesoctocog alfa
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS INJECTION
- Route
- INTRAVENOUS INJECTION
- Authorisation Status
- Marketing authorisation number EU/1/24/1824/006 present
- Orphan Designation
- Yes
- Starting Dose
- 50 IU/kg
- Dose Levels
- 50 IU/kg
- Frequency
- once-weekly
- Maximum Dose
- 50 IU/kg (max daily dose amount listed as 50 IU/kg)
- Investigational Product Name
- ALTUVOCT 4 000 IU powder and solvent for solution for injection
- Active Substance
- efanesoctocog alfa
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS INJECTION
- Route
- INTRAVENOUS INJECTION
- Authorisation Status
- Marketing authorisation number EU/1/24/1824/007 present
- Orphan Designation
- Yes
- Starting Dose
- 50 IU/kg
- Dose Levels
- 50 IU/kg
- Frequency
- once-weekly
- Maximum Dose
- 50 IU/kg (max daily dose amount listed as 50 IU/kg)
- Investigational Product Name
- ALTUVOCT 250 IU powder and solvent for solution for injection
- Active Substance
- efanesoctocog alfa
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS INJECTION
- Route
- INTRAVENOUS INJECTION
- Authorisation Status
- Marketing authorisation number EU/1/24/1824/001 present
- Orphan Designation
- Yes
- Starting Dose
- 50 IU/kg
- Dose Levels
- 50 IU/kg
- Frequency
- once-weekly
- Maximum Dose
- 50 IU/kg (max daily dose amount listed as 50 IU/kg)
- Investigational Product Name
- ALTUVOCT 500 IU powder and solvent for solution for injection
- Active Substance
- efanesoctocog alfa
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS INJECTION
- Route
- INTRAVENOUS INJECTION
- Authorisation Status
- Marketing authorisation number EU/1/24/1824/002 present (authorization country code NO for one pack)
- Orphan Designation
- Yes
- Starting Dose
- 50 IU/kg
- Dose Levels
- 50 IU/kg
- Frequency
- once-weekly
- Maximum Dose
- 50 IU/kg (max daily dose amount listed as 50 IU/kg)
- Investigational Product Name
- ALTUVOCT 1 000 IU powder and solvent for solution for injection
- Active Substance
- efanesoctocog alfa
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS INJECTION
- Route
- INTRAVENOUS INJECTION
- Authorisation Status
- Marketing authorisation number EU/1/24/1824/004 present
- Orphan Designation
- Yes
- Starting Dose
- 50 IU/kg
- Dose Levels
- 50 IU/kg
- Frequency
- once-weekly
- Maximum Dose
- 50 IU/kg (max daily dose amount listed as 50 IU/kg)
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