Clinical trial • Phase III • Gastroenterology

APRAGLUTIDE for Short bowel syndrome

Phase III trial of APRAGLUTIDE for Short bowel syndrome. open-label, none/not specified-controlled. 51 participants.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Short bowel syndrome
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
29-05-2024
First CTIS Authorization Date
08-07-2024

Trial design

open-label, none/not specified-controlled Phase III trial across 37 sites in Poland, France, Norway and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
51
Trial Duration For Participant
2184

Eligibility

Recruits 51 Vulnerable population selected. Inclusion criterion 2 requires: "2. Able to give informed consent and agree to follow the details of participation as outlined in this protocol". No specific assent or guardian/parental consent procedures for minors are described in the available documents..

Vulnerable Population
Vulnerable population selected. Inclusion criterion 2 requires: "2. Able to give informed consent and agree to follow the details of participation as outlined in this protocol". No specific assent or guardian/parental consent procedures for minors are described in the available documents.

Inclusion criteria

  • {"criterion_text":"- 1. Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with CIC or stoma, who were trial subjects of TA799-007 or TA799-013 (parent trials) and: a. Did not meet any stopping criteria b. For those subjects who completed a parent trial, they have received a minimum of 70% of the planned doses in the trial (unless an AE precluded the subject from meeting this percentage; in this case, the Investigator will decide if the subject will benefit from enrolling in the trial) c. For those subjects who completed a parent trial, they have completed the last two scheduled visits of the parent trial. Subjects who were forced to withdraw from TA799-007 or TA799-013 for logistical reasons not related to the efficacy or safety of apraglutide (e.g., hospitalization for a car accident, coronavirus disease [COVID-19] pandemic, emergency surgery, etc.), which resulted in several consecutive missed doses, including the last 2 visits, may be eligible to participate in this trial upon approval by the Medical Monitor d. When the required number of trial-completed subjects is achieved in a parent trial, the remaining subjects still on treatment may prematurely discontinue the parent trial and roll over into TA799-012 (before completing all the parent trial visits). Criterion “d” was not applicable to sites in France\n- 2. Able to give informed consent and agree to follow the details of participation as outlined in this protocol\n- 3. Women of childbearing potential must agree to use a highly effective method of contraception during the trial and for 4 weeks after the EOT/early termination visit. Such methods include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner. To be considered sterilized or infertile, females must have undergone surgical sterilization (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be postmenopausal (defined as at least 12 months amenorrhea without an alternative medical cause, may be confirmed with follicle-stimulating hormone [FSH] test in case of doubt). Women who do not engage in heterosexual intercourse will be allowed to join the trial without contraception following a thorough discussion with the Investigator to determine if this is feasible for the subject. The following methods are not considered acceptable methods of contraception: calendar, ovulation, symptothermal, post-ovulation methods, withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method\n- 4. Male subjects with a female partner of childbearing potential must commit to practice methods of contraception and abstain from sperm donation during the trial and for 2 weeks after the EOT/early termination visit. Nevertheless, if their partners are women of childbearing potential, they must agree to practice contraception and use a highly effective method of contraception during the trial and for 4 weeks after the EOT/early termination visit. Such methods include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device; intrauterine hormone-releasing system, bilateral tubal occlusion"}

Exclusion criteria

  • {"criterion_text":"- 1. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements\n- 2. Subject not undergoing a baseline colonoscopy (if anatomically feasible) or CT/MRI colonography and not having had all identified colonic or rectal polyps removed\n- 3. Judged not eligible by the Investigator for any other reason"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Adverse events (AEs; system organ class, frequency and severity)","definition_or_measurement_approach":"AEs to be captured by system organ class, frequency and severity (safety reporting according to standard AE collection and coding)."}
  • {"endpoint_text":"- 2. Occurrence of clinically relevant AEs of special interest (AESIs): o Injection site reactions o Gastrointestinal (GI) obstructions o Gallbladder, biliary and pancreatic disease o Fluid overload o Colorectal polyps o Malignancies","definition_or_measurement_approach":"Occurrence of predefined AESIs including injection site reactions, GI obstructions, gallbladder/biliary/pancreatic disease, fluid overload, colorectal polyps, and malignancies (clinically relevant events of special interest captured and reported)."}
  • {"endpoint_text":"- 3. Clinical chemistry, hematology, hemostasis and urinalysis","definition_or_measurement_approach":"Laboratory assessments including clinical chemistry, hematology, hemostasis panels and urinalysis performed per schedule to detect clinically relevant changes."}
  • {"endpoint_text":"- 4. Occurrence of clinically relevant changes in vital signs (systolic and diastolic blood pressure, heart rate)","definition_or_measurement_approach":"Vital signs (systolic/diastolic blood pressure and heart rate) measured at scheduled visits; clinically relevant changes recorded."}
  • {"endpoint_text":"- 5. Occurrence of clinically relevant changes in electrocardiogram (ECG; intervals and rhythm)","definition_or_measurement_approach":"ECG intervals and rhythm assessed per schedule; clinically relevant changes (intervals/rhythm) recorded."}

Secondary endpoints

  • {"endpoint_text":"- 1. Change from baseline in PS volume at Weeks 52, 104, 152, 216, 264 and 312","definition_or_measurement_approach":"Change from baseline in parenteral support (PS) volume measured at specified weeks (52, 104, 152, 216, 264, 312)."}
  • {"endpoint_text":"- 2. Change from baseline in PS frequency at Weeks 52, 104, 152, 216, 264 and 312","definition_or_measurement_approach":"Change from baseline in frequency of PS administrations measured at specified weeks."}
  • {"endpoint_text":"- 3. Change from baseline in PS composition at Weeks 52, 104, 152, 216, 264 and 312","definition_or_measurement_approach":"Change from baseline in PS composition (nutrient components) measured at specified weeks."}
  • {"endpoint_text":"- 4. Change from baseline in PS infusion time at Weeks 52, 104, 152, 216, 264 and 312","definition_or_measurement_approach":"Change from baseline in PS infusion duration measured at specified weeks."}
  • {"endpoint_text":"- 5. Percentage of subjects reaching enteral autonomy by Weeks 52, 104, 152, 216, 264 and 312","definition_or_measurement_approach":"Proportion of subjects achieving enteral autonomy (no PS requirement) by specified weeks."}
  • {"endpoint_text":"- 6. Change from baseline in body weight at Weeks 52, 104, 152, 216, 264 and 312","definition_or_measurement_approach":"Change from baseline in body weight measured at specified weeks."}
  • {"endpoint_text":"- 7. Change from baseline on the Pittsburgh Sleep Quality Index (PSQI) at Weeks 52, 104, 152, 216, 264 and 312","definition_or_measurement_approach":"Change from baseline in PSQI score measured at specified weeks."}
  • {"endpoint_text":"- 8. Change from baseline on the Patient Global Impression of Change (PGIC) at Weeks 52, 104, 152, 216, 264 and 312","definition_or_measurement_approach":"Change from baseline in PGIC assessed at specified weeks."}
  • {"endpoint_text":"- 9. Change from baseline on the Patient Global Impression of Severity (PGIS) at Weeks 52, 104, 152, 216, 264 and 312","definition_or_measurement_approach":"Change from baseline in PGIS assessed at specified weeks."}
  • {"endpoint_text":"- 10. Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS) at Weeks 52, 104, 152, 216, 264 and 312","definition_or_measurement_approach":"Change from baseline in PGI-TS assessed at specified weeks."}
  • {"endpoint_text":"- 11. Changes from baseline on Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS) at Weeks 52, 104, 152, 216, 264 and 312","definition_or_measurement_approach":"Change from baseline in PGI-SPS assessed at specified weeks."}
  • {"endpoint_text":"- 12. Changes from baseline on Patient Global Impression of Parenteral Support Impact (PGI-PSI) at Weeks 52, 104, 152, 216, 264 and 312","definition_or_measurement_approach":"Change from baseline in PGI-PSI assessed at specified weeks."}
  • {"endpoint_text":"- 13. Change from baseline on the Short Form (36) Health Survey (SF-36) at Weeks 52, 104, 152, 216, 264 and 312","definition_or_measurement_approach":"Change from baseline in SF-36 scores measured at specified weeks."}
  • {"endpoint_text":"- 14. Change from baseline on the EuroQoL-5 dimension - 5 level survey (EQ-5D-5L) at Weeks 52, 104, 152, 216, 264 and 312","definition_or_measurement_approach":"Change from baseline in EQ-5D-5L scores measured at specified weeks."}

Recruitment

Planned Sample Size
51
Recruitment Window Months
103
Consent Approach
Subjects must be able to give informed consent: "2. Able to give informed consent and agree to follow the details of participation as outlined in this protocol". Subject information and informed consent form (SIS and ICF) documents are provided and available in multiple country/language versions (examples in the document list include English, French, Dutch, Hungarian, Spanish, Italian, German, Czech). No specific assent/parental consent procedures for minors are described in the available documents.

Methods

  • Subjects' traveling concierge service (Meeting Protocol Worldwide LP) - listed in third-party duties as "subjects' traveling concierge service"
  • Home trial visit support (Medical Research Network Limited) - listed in third-party duties as "Home trial visit support"
  • Home trial visit support (Medical Research Network Limited / other third parties) referenced in third-party duties and documents (support for trial visits conducted at home)
  • Recruitment arrangements placeholders/documents exist per country (recruitment_arrangements files present) but specific channels and country-specific recruitment strategies are not described in the available metadata

Geography

Total Number Of Sites
37
Total Number Of Participants
101

Poland

Earliest CTIS Part Ii Submission Date
21-06-2024
Latest Decision Or Authorization Date
04-08-2024
Processing Time Days
44
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
Poradnia Żywieniowa dla Dorosłych
Contact Person Name
Marcin Folwarski
Contact Person Email
marcinfol@gmail.com
Site Name
Niepubliczny Zaklad Opieki Zdrowotnej Stadmedica Sp. z o.o.
Department Name
Ambulatoryjna Opieka Specjalistyczna
Contact Person Name
Marlena Teresa Jakubczyk
Contact Person Email
marljakz@wp.pl
Site Name
Szpital Skawina Sp. z o.o.
Department Name
Poradnia Żywieniowa
Contact Person Name
Stanisław Kłęk
Contact Person Email
klek@poczta.onet.pl
Site Name
Wojewodzki Specjalistyczny Szpital Im. M. Pirogowa W Lodzi
Department Name
Centrum Leczenia Żywieniowego
Contact Person Name
Marek Kunecki
Contact Person Email
marek.kunecki@vp.pl
Site Name
Scanmed S.A.
Department Name
Gastromed Zakład Opieki Zdrowotnej – Poradnie
Contact Person Name
Przemysław Matras
Contact Person Email
dr.matras@gmail.com

France

Earliest CTIS Part Ii Submission Date
21-06-2024
Latest Decision Or Authorization Date
09-07-2024
Processing Time Days
18
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Hopital Beaujon
Department Name
Service de gastroentérologie, MICI et assistance nutritive
Contact Person Name
Francisca Joly-Gomez
Contact Person Email
francisca.joly@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Unité de Rechecher Clinique Gastroentérologie et Nutrition Clinique
Contact Person Name
Stephane Schneider
Contact Person Email
schneider.s@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service de Hépato-Gastro-entérologie et oncologie digestive
Contact Person Name
Florian Poullenot
Site Name
CHRU De Nancy
Department Name
Service d'Endocrinologie, Diabéte et Nutrition
Contact Person Name
Didier Quilliot
Contact Person Email
d.quilliot@chru-nancy.fr
Site Name
Hospices Civils De Lyon
Department Name
Service de Hépato-Gastro-Entérologie, Centre Hospitalier Lyon Sud
Contact Person Name
Charlotte Bergoin
Contact Person Email
charlotte.bergoin@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service d'Hépato-gastro-entérologie, Cancérologie Digestive et Assistance Nutritionnelle
Contact Person Name
Adam Jirka
Contact Person Email
adam.jirka@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Nice (duplicate listing possible)
Department Name
Unité de Rechecher Clinique Gastroentérologie et Nutrition Clinique
Contact Person Name
Stephane Schneider
Contact Person Email
schneider.s@chu-nice.fr

Norway

Earliest CTIS Part Ii Submission Date
21-06-2024
Latest Decision Or Authorization Date
08-07-2024
Processing Time Days
17
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Helse Moere Og Romsdal HF
Department Name
Medical department Division of Gastroenterology and Hepatology
Contact Person Name
Faris Salman Majeed
Contact Person Email
Faris.Majeed@helse-mr.no

Belgium

Earliest CTIS Part Ii Submission Date
21-06-2024
Latest Decision Or Authorization Date
08-07-2024
Processing Time Days
17
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
UZ Leuven
Department Name
Gastroenterology
Contact Person Name
Tim Vanuytsel
Contact Person Email
tim.vanuytsel@uzleuven.be
Site Name
UZ Brussel
Department Name
Clinical Nutrition/Intensive Care
Contact Person Name
Elisabeth De Waele
Contact Person Email
Elisabeth.dewaele@uzbrussel.be

Germany

Earliest CTIS Part Ii Submission Date
21-06-2024
Latest Decision Or Authorization Date
09-07-2024
Processing Time Days
18
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Clinic of Endocrinology, diabetology, metabolic diseases and clinical chemistry
Contact Person Name
Alba Sulaj
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medical Clinic for Hepatology and Gastroenterology
Contact Person Name
Christoph Jochum
Contact Person Email
christoph.jochum@charite.de
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Department of Gastroenterology and Hepatology
Contact Person Name
Reinhold Gellner
Contact Person Email
reinhold.gellner@ukmuenster.de
Site Name
Asklepios Klinik St George
Department Name
Internal Medicine and Gastroenterology
Contact Person Name
Ulrich-Frank Pape
Contact Person Email
ul.pape@asklepios.com
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Department for General-, Visceral-, Vascular- and Thoracic Surgery
Contact Person Name
Gun-Soo Hong
Contact Person Email
gun-soo.hong@ukbonn.de

Sweden

Earliest CTIS Part Ii Submission Date
21-06-2024
Latest Decision Or Authorization Date
09-07-2024
Processing Time Days
18
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Sahlgrenska Intestinal Failure and Transplant Centre
Contact Person Name
Ingvar Bosaeus
Contact Person Email
ingvar.bosaeus@vgregion.se

Czechia

Earliest CTIS Part Ii Submission Date
21-06-2024
Latest Decision Or Authorization Date
10-07-2024
Processing Time Days
19
Number Of Sites
5
Number Of Participants
9

Sites

Site Name
Fakultni Nemocnice Brno
Department Name
Interní gastroenterologická klinika
Contact Person Name
Michal Šenkyřík
Contact Person Email
Senkyrik.Michal@fnbrno.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Interní klinika
Contact Person Name
Pavel Těšínský
Contact Person Email
pavel.tesinsky@fnkv.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
III. interní gerontometabolická klinika
Contact Person Name
Jan Maňák
Contact Person Email
manak@lfhk.cuni.cz
Site Name
Fakultni Nemocnice Plzen
Department Name
I. interní klinika
Contact Person Name
Michal Žourek
Contact Person Email
zourek@fnplzen.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
IV. interní klinika - gastroenterologie a hepatologie
Contact Person Name
František Novák
Contact Person Email
frantisek.novak@lf1.cuni.cz

Hungary

Earliest CTIS Part Ii Submission Date
21-06-2024
Latest Decision Or Authorization Date
08-07-2024
Processing Time Days
17
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
University Of Szeged
Department Name
Department of Internal Medicine-Western Site
Contact Person Name
Laszlo Czako
Contact Person Email
czako.laszlo@med.u-szeged.hu
Site Name
Semmelweis University
Department Name
Department of Surgery, Transplantation and Gastroenterology
Contact Person Name
Miklos Horvath
Contact Person Email
steg@semmelweis-univ.hu
Site Name
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz
Department Name
Department of Gastroenterology
Contact Person Name
Gabor Udvarhelyi
Contact Person Email
gasztro@szentimrekorhaz.hu
Site Name
Central Hospital Of Northern Pest Military Hospital
Department Name
Department of Gastroenterology
Contact Person Name
Tibor Gyokeres
Contact Person Email
tiborgyokeres65@gmail.com

Denmark

Earliest CTIS Part Ii Submission Date
21-06-2024
Latest Decision Or Authorization Date
08-07-2024
Processing Time Days
17
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Rigshospitalet
Department Name
Department of Digestive Diseases, Transplantation and General Surgery
Contact Person Name
Palle Jeppesen
Contact Person Email
matias.vested@regionh.dk

Spain

Earliest CTIS Part Ii Submission Date
21-06-2024
Latest Decision Or Authorization Date
08-07-2024
Processing Time Days
17
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Endocrinology and Nutrition Service
Contact Person Name
Maria Irene Maiz Jimenez
Contact Person Email
mariamaizj@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Clinical Nutrition and Dietetics
Contact Person Name
Maria Cristina Cuerda Compes
Contact Person Email
ucaicec@fibhgm.org
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Endocrinology and Nutrition Unit
Contact Person Name
Maria del Pilar Serrano Aguayo
Contact Person Email
piagua@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
21-06-2024
Latest Decision Or Authorization Date
15-07-2024
Processing Time Days
24
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Complex Operative Unit of Internal Medicine and Gastroenterology
Contact Person Name
Antonio Gasbarrini
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Dipartimento Medicina Generale e Specialistica Dietetica e Nutrizione Clinica
Contact Person Name
Umberto Aimasso
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Dept of Digestive, Hepatic, Endocrine-Metabolic Diseases - Clinical Nutrition and Metabolism
Contact Person Name
Anna Simona Sasdelli
Contact Person Email
annasimona.sasdelli@aosp.bo.it

Sponsor

Primary sponsor

Full Name
VectivBio AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Psi Cro AG
Name
Medidata Solutions Inc.
Responsibilities
eCOA
Name
Cerba / Cerba Research
Responsibilities
Serology/endocrinology, clinical chemistry; clinical haematology; logistic and temporary storage of PD, PK and ADA samples
Name
Suvoda LLC
Name
Almac Clinical Services Limited
Name
Altasciences Compagnie Inc.
Responsibilities
PK, Anti Drug Antibodies, neutralizing antibodies, cross-reactivity to endogenous GLP-2
Name
WCG Clinical Inc.
Responsibilities
Adjudication Committee management
Name
Advyzom LLC
Responsibilities
CSR writing
Name
Meeting Protocol Worldwide LP
Responsibilities
subjects' traveling concierge service
Name
Medical Research Network Limited
Responsibilities
Home trial visit support

Third parties

  • {"country":"Germany","full_name":"DATAMAP-Gesellschaft fuer Datenmanagement Datenanalyse und Datenpraesentation mbH","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Meeting Protocol Worldwide LP","duties_or_roles":"subjects' traveling concierge service","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Niche Science & Technology Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"eCOA","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"France","full_name":"Cerba","duties_or_roles":"Serology/endocrinology, clinical chemistry","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"serology/endocrinology, clinical chemistry, clinical haematology, logistic and temporary storage of PD, PK and ADA samples","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Medical Research Network Limited","duties_or_roles":"Home trial visit support","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"PK, Anti Drug Antibodies, neutralizing antibodies, cross-reactivity to endogenous GLP-2","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Adjudication Committee management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Advyzom LLC","duties_or_roles":"CSR writing","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Meeting Protocol Worldwide LP (duplicate listing in third parties)","duties_or_roles":"subjects' traveling concierge service","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Apraglutide
Active Substance
APRAGLUTIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
1
Orphan Designation
Yes
Maximum Dose
3.5 mg

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