Clinical trial • Phase III • Endocrinology|Rare Disease
somapacitan for Short stature | Small for gestational age (SGA) | Turner syndrome | Noonan syndrome | Idiopathic short stature (ISS)
Phase III trial of somapacitan for Short stature | Small for gestational age (SGA) | Turner syndrome | Noonan syndrome | Idiopathic short stature (ISS).
Overview
- Trial Therapeutic Area
- Endocrinology|Rare Disease
- Trial Disease
- Short stature | Small for gestational age (SGA) | Turner syndrome | Noonan syndrome | Idiopathic short stature (ISS)
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
- Paediatric Trial
- Yes
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 14-06-2024
- First CTIS Authorization Date
- 15-07-2024
Trial design
Norditropin FlexPro (active substance: somatropin) used as comparator; administered once daily (dose not specified in CTIS record).-controlled Phase III trial in Germany, Croatia, Portugal and others.
- Comparator
- Norditropin FlexPro (active substance: somatropin) used as comparator; administered once daily (dose not specified in CTIS record).
- Target Sample Size
- 277
- Trial Duration For Participant
- 1911
Eligibility
Recruits 277 paediatric patients.
- Vulnerable Population
- The trial enrolls children (vulnerable population). Informed consent is obtained from the parent(s)/legal representative(s). Age-appropriate assent and child information/consent documents are provided (separate child assent/information forms and legal representative forms are listed). Multiple country- and age-specific SI/IC and assent/legal representative documents are provided (child 6-11, child 12-17, legal representative addenda), indicating assent procedures and parent/legal representative consent handling.
Inclusion criteria
- {"criterion_text":"-No prior exposure to growth promoting therapy, including but not limited to growth hormone, IGF-I and ghrelin analogues."}
- {"criterion_text":"-Applicable to children with SGA: Born small for gestational age (birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards). Japan: Please see local requirements in Appendix 11 (Section 10.11)."}
- {"criterion_text":"-Applicable to children with SGA: Prebubertal Children: a) Boys: - Age above er equal to 2 years and 26 weeks and below 11.0 years at screening. - Testis volume below 4 mL b) Girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. Tanner stage 1 for breast development: No palpable glandular breast tissue"}
- {"criterion_text":"-Applicable to girls with TS: Confirmed diagnosis of TS: CCI United Kingdom: Please see local requirements in Appendix 11 (Section 10.11)."}
- {"criterion_text":"-Applicable to girls with TS: Prepubertal girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. - Tanner stage 1 for breast development: No palpable glandular breast tissue)"}
- {"criterion_text":"-Applicable to children with NS: Clinical diagnosis of NS according to van der Burgt score list (See Table 7) Japan: Please see local requirements in Appendix 11 (Section 10.11)."}
- {"criterion_text":"-Applicable to children with NS: Prepubertal children: a) Boys: - Age above or equal to 2 years and 26 weeks and below 11.0 years at screening. - Testis volume below 4mL b) Girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. -Tanner stage 1 for breast development: No palpable glandular breast tissue"}
- {"criterion_text":"-Applicable to children with ISS: Prepubertal children: a) Boys: - Age above or equal to 2 years and 26 weeks and below 11.0 years at screening. - Testis volume below 4mL b) Girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. -Tanner stage 1 for breast development: No palpable glandular breast tissue"}
- {"criterion_text":"-Applicable to children with ISS: Bone age: a) Boys: - Bone age below or equal to 12 years. - Bone age not delayed or advanced mor than 2 years compared to chronological age. b) Girls: - Bone age below or equal to 11 years - Bone age not delayed or advanced more than 2 years compared to chronological age."}
Exclusion criteria
- {"criterion_text":"-Children with suspected or confirmed growth hormone deficiency according to local practice."}
- {"criterion_text":"-Children diagnosed with diabetes mellitus or screening values from the central laboratory of a. fasting plasma glucose above or equal to 126 mg/dL (7.0 mmol/L) or b. HbA1c above or equal to 6.5%."}
- {"criterion_text":"-Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening."}
Endpoints
Primary endpoints
- {"endpoint_text":"-Height velocity","definition_or_measurement_approach":"Longitudinal growth measured by height velocity at Week 52 (height velocity over 52 weeks)."}
Secondary endpoints
- {"endpoint_text":"-Change in Height SDS","definition_or_measurement_approach":"Change from baseline in height standard deviation score (Height SDS)."}
- {"endpoint_text":"-Change in Height Velocity SDS","definition_or_measurement_approach":"Change from baseline in height velocity expressed as SDS."}
- {"endpoint_text":"-Change in bone age","definition_or_measurement_approach":"Change from baseline in bone age."}
- {"endpoint_text":"-Change in IGF-I SDS","definition_or_measurement_approach":"Change from baseline in IGF-I standard deviation score (IGF-I SDS)."}
- {"endpoint_text":"-Change in IGFBP-3 SDS","definition_or_measurement_approach":"Change from baseline in IGFBP-3 SDS."}
- {"endpoint_text":"-Change in fasting plasma glucose","definition_or_measurement_approach":"Change from baseline in fasting plasma glucose (measured by central laboratory)."}
- {"endpoint_text":"-Change in homeostatic model assessment-B (HOMA-B)","definition_or_measurement_approach":"Change from baseline in HOMA-B index."}
- {"endpoint_text":"-Change in homeostatic model assessment-IR (HOMA-IR)","definition_or_measurement_approach":"Change from baseline in HOMA-IR index."}
- {"endpoint_text":"-Change in glycated haemoglobin (HbA1c)","definition_or_measurement_approach":"Change from baseline in HbA1c (glycated haemoglobin)."}
- {"endpoint_text":"-CCI","definition_or_measurement_approach":""}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 277
- Recruitment Window Months
- 57
- Consent Approach
- Informed consent is obtained from the parent(s)/legal representative(s). Age-appropriate child information and assent forms are used (documents for child assent and information for ages 6-11 and 12-17 are in the CTIS documents). Legal representative/parent information and consent forms and addenda are provided. Multiple country-specific language versions of SI/IC and assent/legal representative documents are available (e.g., DE, HR, PT, ES, FR, IT, PL, BG, GR, NL, LV, LT, SI, FI and others), indicating local-language consent materials.
Methods
- Site-based recruitment at participating hospitals/clinics across the listed member states (sites and principal contacts listed in CTIS).
- Direct-to-patient recruitment/distribution channel (Direct to Patient vendor: Marken Limited).
- Recruitment/retention material development vendor (Jumo Health USA Inc.) to support recruitment materials.
- Use of digital data capture and patient-facing technology (eDiary supplier Medable Inc.; eCRF supplier Oracle Danmark ApS; central laboratory support by IQVIA).
Geography
- Total Number Of Sites
- 46
- Total Number Of Participants
- 277
Germany
- Latest Decision Or Authorization Date
- 18-07-2024
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Universitaetsklinikum Bonn AöR
- Principal Investigator Name
- Bettina Gohlke
- Principal Investigator Email
- bettina.gohlke@ukbonn.de
- Contact Person Name
- Bettina Gohlke
- Contact Person Email
- bettina.gohlke@ukbonn.de
- Site Name
- Endokrinologikum Frankfurt
- Principal Investigator Name
- Volker Böttcher
- Principal Investigator Email
- volker.boettcher@amedes-group.com
- Contact Person Name
- Volker Böttcher
- Contact Person Email
- volker.boettcher@amedes-group.com
Croatia
- Latest Decision Or Authorization Date
- 19-07-2024
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Klinicki bolnicki centar Sestre milosrdnice
- Principal Investigator Name
- Lavinia La Grasta Sabolic
- Principal Investigator Email
- REAL8KBCSM@gmail.com
- Contact Person Name
- Lavinia La Grasta Sabolic
- Contact Person Email
- REAL8KBCSM@gmail.com
Portugal
- Latest Decision Or Authorization Date
- 23-08-2024
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Principal Investigator Name
- Maria de Lurdes Sampaio
- Principal Investigator Email
- lurdes.sampaio@chln.min-saude.pt
- Contact Person Name
- Maria de Lurdes Sampaio
- Contact Person Email
- lurdes.sampaio@chln.min-saude.pt
- Site Name
- Unidade Local De Saude De Gaia/Espinho E.P.E.
- Principal Investigator Name
- Ana Luísa Leite
- Principal Investigator Email
- ana.leite@ulsge.min-saude.pt
- Contact Person Name
- Ana Luísa Leite
- Contact Person Email
- ana.leite@ulsge.min-saude.pt
- Site Name
- Unidade Local De Saude De Sao Jose E.P.E.
- Principal Investigator Name
- Catarina Diamantino
- Principal Investigator Email
- catarina.diamantino@ulssjose.min-saude-pt
- Contact Person Name
- Catarina Diamantino
- Contact Person Email
- catarina.diamantino@ulssjose.min-saude-pt
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Principal Investigator Name
- Teresa Borges
- Principal Investigator Email
- u05920@chporto.min-saude.pt
- Contact Person Name
- Teresa Borges
- Contact Person Email
- u05920@chporto.min-saude.pt
Belgium
- Latest Decision Or Authorization Date
- 23-07-2024
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Antwerp University Hospital
- Principal Investigator Name
- Hilde Dotremont
- Principal Investigator Email
- Hilde.Dotremont@uza.be
- Contact Person Name
- Hilde Dotremont
- Contact Person Email
- Hilde.Dotremont@uza.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Principal Investigator Name
- Philippe Lysy
- Principal Investigator Email
- philippe.lysy@uclouvain.be
- Contact Person Name
- Philippe Lysy
- Contact Person Email
- philippe.lysy@uclouvain.be
- Site Name
- UZ Leuven
- Principal Investigator Name
- Anne Rochtus
- Principal Investigator Email
- anne.rochtus@uzleuven.be
- Contact Person Name
- Anne Rochtus
- Contact Person Email
- anne.rochtus@uzleuven.be
- Site Name
- UZ Brussel
- Principal Investigator Name
- Inge Gies
- Principal Investigator Email
- inge.gies@uzbrussel.be
- Contact Person Name
- Inge Gies
- Contact Person Email
- inge.gies@uzbrussel.be
Spain
- Latest Decision Or Authorization Date
- 17-07-2024
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Sant Joan De Deu Barcelona Hospital
- Principal Investigator Name
- Montserrat Amat Bou
- Principal Investigator Email
- montserrat.amat@sjd.es
- Contact Person Name
- Montserrat Amat Bou
- Contact Person Email
- montserrat.amat@sjd.es
- Site Name
- Hospital Universitario Hm Monteprincipe
- Principal Investigator Name
- Amparo Rodríguez Sánchez
- Principal Investigator Email
- amparorodriguezsanchez@yahoo.es
- Contact Person Name
- Amparo Rodríguez Sánchez
- Contact Person Email
- amparorodriguezsanchez@yahoo.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Principal Investigator Name
- Jesús Barreiro
- Principal Investigator Email
- jesus.barreiro.conde@sergas.es
- Contact Person Name
- Jesús Barreiro
- Contact Person Email
- jesus.barreiro.conde@sergas.es
Poland
- Latest Decision Or Authorization Date
- 04-08-2024
- Number Of Sites
- 4
- Number Of Participants
- 28
Sites
- Site Name
- Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
- Principal Investigator Name
- Agnieszka Zachurzok
- Principal Investigator Email
- azachurzok@sum.edu.pl
- Contact Person Name
- Agnieszka Zachurzok
- Contact Person Email
- azachurzok@sum.edu.pl
- Site Name
- Instytut Centrum Zdrowia Matki Polki
- Department Name
- Klinika Endokrynologii i Chorób Metabolicznych
- Principal Investigator Name
- Renata Stawerska
- Principal Investigator Email
- renata.stawerska@iczmp.edu.pl
- Contact Person Name
- Renata Stawerska
- Contact Person Email
- renata.stawerska@iczmp.edu.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Principal Investigator Name
- Joanna Bautembach
- Principal Investigator Email
- bauti@gumed.edu.pl
- Contact Person Name
- Joanna Bautembach
- Contact Person Email
- bauti@gumed.edu.pl
- Site Name
- Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie
- Principal Investigator Name
- Artur Mazur
- Principal Investigator Email
- drmazur@poczta.onet.pl
- Contact Person Name
- Artur Mazur
- Contact Person Email
- drmazur@poczta.onet.pl
Lithuania
- Latest Decision Or Authorization Date
- 24-07-2024
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
- Principal Investigator Name
- Rasa Verkauskiene
- Principal Investigator Email
- rasa.verkauskiene@gmail.com
- Contact Person Name
- Rasa Verkauskiene
- Contact Person Email
- rasa.verkauskiene@gmail.com
Bulgaria
- Latest Decision Or Authorization Date
- 18-07-2024
- Number Of Sites
- 4
- Number Of Participants
- 19
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
- Department Name
- Clinic of Pediatrics, Department of Pediatric, Endocrinology and Metabolic Diseases
- Principal Investigator Name
- Irina Halvadzhiyan
- Principal Investigator Email
- irina.halvadjian@gmail.com
- Contact Person Name
- Irina Halvadzhiyan
- Contact Person Email
- irina.halvadjian@gmail.com
- Site Name
- Specialized Hospital For Active Treatment Of Childrens Diseases Professor Ivan Mitev
- Department Name
- Clinic of pediatric endocrinology and metabolic diseases
- Principal Investigator Name
- Desislava Yordanova
- Principal Investigator Email
- dex2001@abv.bg
- Contact Person Name
- Desislava Yordanova
- Contact Person Email
- dex2001@abv.bg
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Clinic of Pediatric
- Principal Investigator Name
- Tsvetelina Tsvetanova
- Principal Investigator Email
- tsetsi_tsetsi@yahoo.co.uk
- Contact Person Name
- Tsvetelina Tsvetanova
- Contact Person Email
- tsetsi_tsetsi@yahoo.co.uk
- Site Name
- MBAL Sveta Marina EAD
- Department Name
- First pediatric clinic, Pediatric department for intensive treatment
- Principal Investigator Name
- Violeta Iotova
- Principal Investigator Email
- iotova_v@abv.bg
- Contact Person Name
- Violeta Iotova
- Contact Person Email
- iotova_v@abv.bg
France
- Latest Decision Or Authorization Date
- 22-07-2024
- Number Of Sites
- 6
- Number Of Participants
- 11
Sites
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Principal Investigator Name
- Regis Coutant
- Principal Investigator Email
- recoutant@chu-angers.fr
- Contact Person Name
- Regis Coutant
- Contact Person Email
- recoutant@chu-angers.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Principal Investigator Name
- Michel Polak
- Principal Investigator Email
- michel.polak@aphp.fr
- Contact Person Name
- Michel Polak
- Contact Person Email
- michel.polak@aphp.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Principal Investigator Name
- Rachel REYNAUD
- Principal Investigator Email
- rachel.REYNAUD@ap-hm.fr
- Contact Person Name
- Rachel REYNAUD
- Contact Person Email
- rachel.REYNAUD@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Principal Investigator Name
- Pascal BARAT
- Principal Investigator Email
- pascal.barat@chu-bordeaux.fr
- Contact Person Name
- Pascal BARAT
- Contact Person Email
- pascal.barat@chu-bordeaux.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Le Kremlin-Bicetre)
- Principal Investigator Name
- Agnès Linglart
- Principal Investigator Email
- agnes.linglart@aphp.fr
- Contact Person Name
- Agnès Linglart
- Contact Person Email
- agnes.linglart@aphp.fr
- Site Name
- Hopital Des Enfants (Toulouse)
- Principal Investigator Name
- Thomas Edouard
- Principal Investigator Email
- edouard.t@chu-toulouse.fr
- Contact Person Name
- Thomas Edouard
- Contact Person Email
- edouard.t@chu-toulouse.fr
Finland
- Latest Decision Or Authorization Date
- 18-07-2024
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- HUS-Yhtymae
- Principal Investigator Name
- Matti Hero
- Principal Investigator Email
- matti.hero@hus.fi
- Contact Person Name
- Matti Hero
- Contact Person Email
- matti.hero@hus.fi
Austria
- Latest Decision Or Authorization Date
- 22-07-2024
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Kepler Universitaetsklinikum GmbH
- Department Name
- Med Campus IV, Abteilung für Kinder- und Jugendheilkunde
- Principal Investigator Name
- Thomas Hörtenhuber
- Principal Investigator Email
- thomas.hoertenhuber@kepleruniklinikum.at
- Contact Person Name
- Thomas Hörtenhuber
- Contact Person Email
- thomas.hoertenhuber@kepleruniklinikum.at
Greece
- Latest Decision Or Authorization Date
- 22-07-2024
- Number Of Sites
- 7
- Number Of Participants
- 18
Sites
- Site Name
- General University Hospital Of Patras
- Department Name
- Department of Pediatrics
- Principal Investigator Name
- Dionysios Chrysis
- Principal Investigator Email
- dchrysis@upatras.gr
- Contact Person Name
- Dionysios Chrysis
- Contact Person Email
- dchrysis@upatras.gr
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- A' Pediatrics Clinic
- Principal Investigator Name
- Athanasios Christoforidis
- Principal Investigator Email
- christoforidis@doctors.org.uk
- Contact Person Name
- Athanasios Christoforidis
- Contact Person Email
- christoforidis@doctors.org.uk
- Site Name
- Nosokomeio Paidon I Agia Sofia
- Department Name
- First Department of Paediatrics
- Principal Investigator Name
- Evangelia Charmandari
- Principal Investigator Email
- evangelia.charmandari@gmail.com
- Contact Person Name
- Evangelia Charmandari
- Contact Person Email
- evangelia.charmandari@gmail.com
- Site Name
- University General Hospital Attikon
- Department Name
- Pediatric Endocrinology-Metabolism and Diabetes Unit, 3rd Department of Pediatrics
- Principal Investigator Name
- Fotini-Eleni Karachaliou
- Principal Investigator Email
- pedoendostudy@attikonhospital.gr
- Contact Person Name
- Fotini-Eleni Karachaliou
- Contact Person Email
- pedoendostudy@attikonhospital.gr
- Site Name
- Athens General Children's Hospital Panagioti And Aglaia Kyriakou
- Department Name
- Department of Endocrinology Growth and Development
- Principal Investigator Name
- Elpis Athina Vlachopapadopoulou
- Principal Investigator Email
- elpis.vl@gmail.com
- Contact Person Name
- Elpis Athina Vlachopapadopoulou
- Contact Person Email
- elpis.vl@gmail.com
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- 3rd Department Of Pediatrics
- Principal Investigator Name
- Charalampos Antachopoulos
- Principal Investigator Email
- bantacho@yahoo.gr
- Contact Person Name
- Charalampos Antachopoulos
- Contact Person Email
- bantacho@yahoo.gr
- Site Name
- University General Hospital Of Thessaloniki Ahepa
- Department Name
- 2nd Department of Pediatrics
- Principal Investigator Name
- Assimina Galli-Tsinopoulou
- Principal Investigator Email
- agalli@auth.gr
- Contact Person Name
- Assimina Galli-Tsinopoulou
- Contact Person Email
- agalli@auth.gr
Netherlands
- Latest Decision Or Authorization Date
- 15-07-2024
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Principal Investigator Name
- Danielle Van der Kaay
- Principal Investigator Email
- d.vanderkaay@erasmusmc.nl
- Contact Person Name
- Danielle Van der Kaay
- Contact Person Email
- d.vanderkaay@erasmusmc.nl
Slovenia
- Latest Decision Or Authorization Date
- 19-07-2024
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- University Medical Center Ljubljana
- Department Name
- PeK - Dept. of Paediatric Endocrinology, Diabetes and Metabolism
- Principal Investigator Name
- Tadej Battelino
- Principal Investigator Email
- tadej.battelino@mf.uni-lj.si
- Contact Person Name
- Tadej Battelino
- Contact Person Email
- tadej.battelino@mf.uni-lj.si
Latvia
- Latest Decision Or Authorization Date
- 08-08-2024
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Bernu Kliniska Universitates Slimnica VSIA
- Principal Investigator Name
- Iveta Dzivite-Krisane
- Principal Investigator Email
- iveta.dzivite@bkus.lv
- Contact Person Name
- Iveta Dzivite-Krisane
- Contact Person Email
- iveta.dzivite@bkus.lv
Italy
- Latest Decision Or Authorization Date
- 22-07-2024
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Ospedale Pediatrico Bambino Gesu
- Principal Investigator Name
- Laura Chioma
- Principal Investigator Email
- laura.chioma@opbg.net
- Contact Person Name
- Laura Chioma
- Contact Person Email
- laura.chioma@opbg.net
- Site Name
- Azienda Ospedaliera Universitaria Meyer IRCCS
- Principal Investigator Name
- Stefano Stagi
- Principal Investigator Email
- stefano.stagi@unifi.it
- Contact Person Name
- Stefano Stagi
- Contact Person Email
- stefano.stagi@unifi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Principal Investigator Name
- Giuseppe Zampino
- Principal Investigator Email
- giuseppe.zampino@unicatt.it
- Contact Person Name
- Giuseppe Zampino
- Contact Person Email
- giuseppe.zampino@unicatt.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Principal Investigator Name
- Gabriella Cinzia Pozzobon
- Principal Investigator Email
- pozzobon.gabriella@hsr.it
- Contact Person Name
- Gabriella Cinzia Pozzobon
- Contact Person Email
- pozzobon.gabriella@hsr.it
- Site Name
- Seconda Universita Di Napoli
- Principal Investigator Name
- Anna Grandone
- Principal Investigator Email
- anna.grandone@unicampania.it
- Contact Person Name
- Anna Grandone
- Contact Person Email
- anna.grandone@unicampania.it
Sponsor
Primary sponsor
- Full Name
- Novo Nordisk A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Contract research organisations
- Name
- 4G Clinical B.V.
- Responsibilities
- RTSM supplier
- Name
- WCG Clinical Inc.
- Name
- Syneos Health Inc.
- Responsibilities
- Special Laboratory
- Name
- IQVIA Limited
- Responsibilities
- Central Laboratory: analysis of safety parameters and pharmacodynamics
Third parties
- {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM supplier","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Recruitment/retention material development vendor","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United Kingdom","full_name":"University Of Manchester","duties_or_roles":"Special Laboratory","organisation_type":"Educational Institution"}
- {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translation Supplier","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Special Laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"eDiary Supplier","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Marken Limited","duties_or_roles":"Direct to Patient","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"Oracle Danmark ApS","duties_or_roles":"eCRF supplier","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Imaging Laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"Special Laboratory","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"Special Laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Affidea Piraeus Biopathological","duties_or_roles":"TTE, ECG","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"TTE, ECG, Xray for bone age assessment","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Central Laboratory: analysis of safety parameters and pharmacodynamics","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Sogroya 5 mg/1.5 mL solution for injection in pre-filled pen
- Active Substance
- somapacitan
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Frequency
- Once weekly
- Investigational Product Name
- Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen
- Active Substance
- somapacitan
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Frequency
- Once weekly
- Investigational Product Name
- Sogroya 15 mg/1.5 mL solution for injection in pre-filled pen
- Active Substance
- somapacitan
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Frequency
- Once weekly
- Investigational Product Name
- Norditropin FlexPro, solution for injection in filled pen
- Active Substance
- somatropin
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised
- Frequency
- Once daily
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