Clinical trial • Phase III • Oncology|Rare Disease
RUSFERTIDE for Polycythemia vera
Phase III trial of RUSFERTIDE for Polycythemia vera.
Overview
- Trial Therapeutic Area
- Oncology|Rare Disease
- Trial Disease
- Polycythemia vera
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 29-02-2024
- First CTIS Authorization Date
- 10-04-2024
Trial design
Randomised, placebo to match ptg-300 for injection (formulation (lyophilized powder) based upon that of ptg-300 for injection, with the drug substance omitted).-controlled Phase III trial across 52 sites in Spain, Portugal, Belgium and others.
- Randomised
- Yes
- Comparator
- Placebo to Match PTG-300 for Injection (Formulation (lyophilized powder) based upon that of PTG-300 for Injection, with the drug substance omitted).
- Target Sample Size
- 148
- Trial Duration For Participant
- 224
Eligibility
Recruits 148 Vulnerable population is selected in the CTIS record (isVulnerablePopulationSelected = true). Subject information and informed consent forms (L1_SIS and ICF documents) are listed in multiple versions and languages. No explicit assent procedures or detailed consent/assent handling text is provided in the record beyond the inclusion criterion that participants must be aged 18 or older (or the country-specific minimum age of consent)..
- Vulnerable Population
- Vulnerable population is selected in the CTIS record (isVulnerablePopulationSelected = true). Subject information and informed consent forms (L1_SIS and ICF documents) are listed in multiple versions and languages. No explicit assent procedures or detailed consent/assent handling text is provided in the record beyond the inclusion criterion that participants must be aged 18 or older (or the country-specific minimum age of consent).
Inclusion criteria
- {"criterion_text":"- 1 - Male and female subjects aged 18 (or the minimum country specific age of consent if >18) years or older.\n- 2 - Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera\n- 3 - Phlebotomy requiring defined as ALL of the following: a. At least 3 phlebotomies due to inadequate hematocrit control in 28 weeks before randomization or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before randomization, and b. Last phlebotomy due to inadequate hematocrit control within 3 months before randomization, and c. No phlebotomy within 6 days prior to randomization (do not include day of phlebotomy and day of randomization in the 6-day count). Note: Phlebotomies performed within an 8-day period will be counted as a single phlebotomy\n- 4 - CBC values immediately prior to randomization: a. Hematocrit <45%, b. WBC 4000/µL to 20,000/µL (inclusive) and c. Platelets 100,000/µL to 1,000,000/µL (inclusive).\n- 5 - Subjects receiving cytoreductive therapy at randomization must be on a stable PV therapy regimen\n- 6 - Subjects treated with phlebotomy alone at randomization must have stopped cytoreductive therapy 2 to 6 months before screening."}
Exclusion criteria
- {"criterion_text":"- 1 - Clinically meaningful laboratory abnormalities at Screening\n- 2 - Subjects who require phlebotomy at hematocrit levels lower than 45%\n- 3 - Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 2 months prior to randomization.\n- 4 - Active or chronic bleeding within 2 months prior to randomization.\n- 5 - History of invasive malignancies within the last 5 years, except a) localized cured cancer (e.g. prostate cancer and cervical cancer). b) localized cured in situ or stage 1 squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or in situ melanoma of the skin.\n- 6 - Subjects with in situ or stage 1 squamous cell carcinoma of the skin, in situ or stage 1 basal cell carcinoma of the skin, or in situ melanoma of the skin identified during screening unless the cancer is adequately treated before randomization.\n- 7 - Received busulfan, pipobroman or 32Phosphorus within 7 months prior to screening."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of subjects achieving a response starting at Week 20 through Week 32 (inclusive) who receive rusfertide compared to placebo. A response is defined as absence of phlebotomy eligibility. Phlebotomy eligibility is defined as either: • a confirmed hematocrit ≥45% and that is at least 3% higher than the baseline hematocrit (value immediately prior to randomization at Week 0); or • a hematocrit ≥48%.","definition_or_measurement_approach":"Response defined as absence of phlebotomy eligibility. Phlebotomy eligibility defined as either: a confirmed hematocrit ≥45% and at least 3% higher than baseline hematocrit (value immediately prior to randomization at Week 0), or a hematocrit ≥48%. Endpoint measured as proportion of subjects achieving response between Week 20 and Week 32 inclusive, comparing rusfertide to placebo."}
Secondary endpoints
- {"endpoint_text":"- 1 - Mean number of phlebotomies between Week 0 through Week 32 (inclusive).","definition_or_measurement_approach":"Mean count of phlebotomy procedures per subject during Week 0 through Week 32 (inclusive)."}
- {"endpoint_text":"- 2 - Proportion of subjects with all hematocrit values <45% between Week 0 through Week 32 (inclusive).","definition_or_measurement_approach":"Proportion of subjects whose hematocrit measurements are all <45% during Week 0 through Week 32 (inclusive)."}
- {"endpoint_text":"- 3 - Mean change from baseline at end of Part 1a (Week 32) in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a total T-score","definition_or_measurement_approach":"Mean change from baseline to Week 32 in PROMIS Fatigue Short Form 8a total T-score."}
- {"endpoint_text":"- 4 - Mean change from baseline at end of Part 1a (Week 32) in the Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF)","definition_or_measurement_approach":"Mean change from baseline to Week 32 in MFSAF v4.0 score."}
- {"endpoint_text":"- 5 - Mean change from baseline at end of Part 1a (Week 32) in the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)","definition_or_measurement_approach":"Mean change from baseline to Week 32 in MPN-SAF score."}
Recruitment
- Planned Sample Size
- 148
- Recruitment Window Months
- 55
- Consent Approach
- Informed consent to be obtained from participants (participants must be aged 18 or older, or meet the country-specific minimum age of consent). Subject information and informed consent forms (L1_SIS and ICF) are available in multiple languages and country-specific versions (documents listed include Main ICF and Pregnancy/Partner ICF versions and country-specific ICFs). Languages and country-specific ICFs present in the dossier include English, Dutch, French, German, Italian, Spanish, Polish, Hungarian, Czech, Portuguese and others as indicated by document listings. No assent procedures for minors are provided (minors are not eligible).
Methods
- K1 recruitment arrangements documents submitted per country (country-specific K1 files listed for PL, NL, ES, IT, HU, DE, CZ, BE, AT, FR).
- K2 recruitment materials: Brochure/Trifold, Flyer/Participant Flyer, Dear Colleague Letter, Participant Journey, Patiro documents used as recruitment channels.
- Patient Recruitment responsibilities assigned to Medpace Finland Oy (listed under sponsor third parties).
Geography
- Total Number Of Sites
- 52
- Total Number Of Participants
- 102
Spain
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 27-11-2025
- Processing Time Days
- 623
- Number Of Sites
- 8
- Number Of Participants
- 18
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology
- Contact Person Name
- Blanca Xicoy
- Contact Person Email
- bxicoy@iconcologia.net
- Site Name
- Hospital Quironsalud Zaragoza
- Department Name
- Hematology
- Contact Person Name
- Pilar Giraldo
- Contact Person Email
- giraldocastellano@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematology
- Contact Person Name
- Alberto Alvarez
- Contact Person Email
- aalvar@clinic.cat
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Hematology and Hemotherapy
- Contact Person Name
- Santiago Osorio
- Contact Person Email
- santiago.osorio@salud.madrid.org
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Hematology
- Contact Person Name
- Valentin Garcia
- Contact Person Email
- jvalentingg@gmail.com
- Site Name
- Hospital Del Mar
- Department Name
- Clinic Hematology
- Contact Person Name
- Patricia Velez
- Contact Person Email
- patricia.velez.tenza@psmar.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematology
- Contact Person Name
- Maria Laura Fox
- Contact Person Email
- mlfox@vhebron.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hematology
- Contact Person Name
- Rosa Ayala
- Contact Person Email
- rayaladiaz12@gmail.com
Portugal
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 11-04-2024
- Processing Time Days
- 28
- Number Of Sites
- 4
- Number Of Participants
- 2
Sites
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Medical Oncology
- Contact Person Name
- Herlander Marques
- Contact Person Email
- herlandermarques@hotmail.com
- Site Name
- Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
- Department Name
- Clinical Hematology
- Contact Person Name
- Isabel Oliveira
- Contact Person Email
- isabeloliveira@ipoporto.min-saude.pt
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Immunohemotherapy
- Contact Person Name
- Maria Blanca Polo Guerrero
- Contact Person Email
- maria.guerrero@chln.min-saude.pt
- Site Name
- Hospital Garcia De Orta E.P.E.
- Department Name
- Hemato-oncology
- Contact Person Name
- Inês Conde
- Contact Person Email
- conde.ines@gmail.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 628
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Universiteit Gent
- Department Name
- Haematology
- Contact Person Name
- Dominiek Mazure
- Contact Person Email
- dominiek.mazure@uzgent.be
- Site Name
- UZ Leuven
- Department Name
- Haematology
- Contact Person Name
- Andrzej Mital
- Contact Person Email
- timothy.devos@uzleuven.be
- Site Name
- Het Ziekenhuisnetwerk Antwerpen
- Department Name
- Haematology
- Contact Person Name
- Nikki Charlotta Paul Granacher
- Contact Person Email
- nikki.granacher@zna.be
Netherlands
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 17-11-2025
- Processing Time Days
- 613
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Hematology
- Contact Person Name
- Peter te Boekhorst
- Contact Person Email
- p.teboekhorst@erasmusmc.nl
- Site Name
- Albert Schweitzer Ziekenhuis
- Department Name
- Internal Medicine
- Contact Person Name
- Peter Westerweel
- Contact Person Email
- wetenschap@asz.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 26-01-2026
- Processing Time Days
- 683
- Number Of Sites
- 9
- Number Of Participants
- 21
Sites
- Site Name
- Careggi University Hospital
- Department Name
- Hematology
- Contact Person Name
- Alessandro Maria Vannucchi
- Contact Person Email
- a.vannucchi@unifi.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Medical Oncology
- Contact Person Name
- Alessandro Lucchesi
- Contact Person Email
- alessandro.lucchesi@irst.emr.it
- Site Name
- Azienda Ospedaliera Ospedali Riuniti Marche Nord
- Department Name
- Complex Unit of Hematology and Bone Marrow Transplantation Center
- Contact Person Name
- Alessandro Isidori
- Contact Person Email
- alessandro.isidori@ospedalimarchenord.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Hematology
- Contact Person Name
- Palandri Francesca
- Contact Person Email
- francesca.palandri@unibo.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Hematology
- Contact Person Name
- Alessandro Morotti
- Contact Person Email
- alessandro.morotti@unito.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
- Department Name
- Oncology and hemato-oncology
- Contact Person Name
- Federico Lussana
- Contact Person Email
- flussana@asst-pg23.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- Hematology
- Contact Person Name
- Elisa Rumi
- Contact Person Email
- elisa.rumi@unipv.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Hematology
- Contact Person Name
- Valerio De Stefano
- Contact Person Email
- valerio.destefano@unicatt.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Hematology
- Contact Person Name
- Giulia Benevolo
- Contact Person Email
- gbenevolo@cittadellasalute.to.it
Hungary
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 16-12-2025
- Processing Time Days
- 642
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
- Department Name
- Belgyógyászati-Infektológiai Centrum
- Contact Person Name
- Balazs TAJTI
- Contact Person Email
- tajtibalazs1985@gmail.com
- Site Name
- University Of Debrecen
- Department Name
- Belgyógyászati Klinika B épület Hematológia
- Contact Person Name
- Arpad ILLES
- Contact Person Email
- illes.arpad@med.unideb.hu
Germany
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 17-12-2025
- Processing Time Days
- 643
- Number Of Sites
- 6
- Number Of Participants
- 10
Sites
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- III. Med. Klinik
- Contact Person Name
- Daniel Sasca
- Contact Person Email
- daniel.sasca@unimedizin-mainz.de
- Site Name
- Universitaetsmedizin Greifswald KöR
- Department Name
- Hematology and Oncology
- Contact Person Name
- Adrian Schwarzer
- Contact Person Email
- adrian.schwarzer@med.uni-greifswald.de
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Medizinische Klinik IV
- Contact Person Name
- Steffen Koschmieder
- Contact Person Email
- skoschmieder@ukaachen.de
- Site Name
- OncoResearch Lerchenfeld GmbH
- Department Name
- Praxis
- Contact Person Name
- Thomas Wolff
- Contact Person Email
- t.wolff@oncoresearch-lerchenfeld.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Hämatologie und Onkologie und Tumorimmunologie
- Contact Person Name
- Philipp David Immanuel Le Coutre
- Contact Person Email
- philipp.lecoutre@charite.de
- Site Name
- Gemeinschaftspraxis Haematologie Onkologie
- Department Name
- Gemeinschaftspraxis
- Contact Person Name
- Thomas Illmer
- Contact Person Email
- buero@onkologie-dresden.net
Czechia
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 13-01-2026
- Processing Time Days
- 671
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- I. interní klinika – Hematologické ambulance
- Contact Person Name
- Anna Jonášová
- Contact Person Email
- anna.jonasova@vfn.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Interní hematologická a onkologická klinika
- Contact Person Name
- Jiří Mayer
- Contact Person Email
- mayer.jiri@fnbrno.cz
- Site Name
- University Hospital Olomouc
- Department Name
- Hemato-onkologická klinika
- Contact Person Name
- Antonín Hluší
- Contact Person Email
- antonin.hlusi@fnol.cz
Austria
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 648
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Klinik Hietzing
- Department Name
- 5. Med. Abteilung
- Contact Person Name
- Daniel Lechner-Radner
- Contact Person Email
- daniel.lechner-radner@gesundheitsverbund.at
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Hematology and Oncology
- Contact Person Name
- Veronika Buxhofer-Ausch
- Contact Person Email
- veronika.buxhofer-ausch@ordensklinikum.at
- Site Name
- Kepler Universitaetsklinikum GmbH
- Department Name
- Internal Medicine 3
- Contact Person Name
- Clemens Schmitt
- Contact Person Email
- clemens.schmitt@kepleruniklinikum.at
- Site Name
- Medical University Of Graz
- Department Name
- internal medicine
- Contact Person Name
- Albert Wölfler
- Contact Person Email
- albert.woelfler@medunigraz.at
France
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 10-04-2026
- Processing Time Days
- 757
- Number Of Sites
- 5
- Number Of Participants
- 7
Sites
- Site Name
- Centre Hospitalier Victor Dupouy
- Department Name
- Hematology
- Contact Person Name
- Annalisa Andreoli
- Contact Person Email
- annalisa.andreoli@ch-argenteuil.fr
- Site Name
- Centre Hospitalier Regional D'Angers
- Department Name
- Hematology
- Contact Person Name
- Françoise Boyer
- Contact Person Email
- frboyer-perrard@chu-angers.fr
- Site Name
- Hopital Saint Louis
- Department Name
- Hematology
- Contact Person Name
- Jean-Jacques Kiladjian
- Contact Person Email
- jean-jacques.kiladjian@aphp.fr
- Site Name
- Centre Hospitalier De Beziers
- Department Name
- Hematology
- Contact Person Name
- Yuriy Drebit
- Contact Person Email
- yuriy.drebit@ch-beziers.fr
- Site Name
- Centre Hospitalier Lyon Sud
- Department Name
- Hematology
- Contact Person Name
- Vincent Alcazer
- Contact Person Email
- Vincent.alcazer@chu-lyon.fr
Poland
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 05-12-2025
- Processing Time Days
- 631
- Number Of Sites
- 6
- Number Of Participants
- 10
Sites
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o. (Bydgoszcz)
- Department Name
- Centrum Medyczne Bydgoszcz
- Contact Person Name
- Jarosław Czyż
- Contact Person Email
- aleksandra.robak@medicover.com
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Hematologii i Transplantologii
- Contact Person Name
- Andrzej Mital
- Contact Person Email
- hematologia@uck.gda.pl
- Site Name
- Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
- Department Name
- Oddział Hematologii Onkologicznej z Pododdziałem Transplantologii Klinicznej
- Contact Person Name
- Jacek Krzanowski
- Contact Person Email
- badaniadsawka@szpital-brzozow.pl
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o. (Torun)
- Department Name
- Centrum Medyczne Toruń
- Contact Person Name
- Marcin Rymko
- Contact Person Email
- ewa.rymko@medicover.com
- Site Name
- Melita Medical Sp. z o.o.
- Contact Person Name
- Justyna Rybka
- Contact Person Email
- b.lapuszynski@melitamedical.pl
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Oddział Hematologii Ogólnej i Chorób Wewnętrznych
- Contact Person Name
- Tadeusz Robak
- Contact Person Email
- robaktad@csk.umed.lodz.pl
Sponsor
Primary sponsor
- Full Name
- Protagonist Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Suvoda LLC
- Responsibilities
- sponsorDuties codes: 3
- Name
- Medpace Finland Oy
- Responsibilities
- Multiple sponsorDuties including code 15 with value 'Patient Recruitment' and other duty codes (1,2,5,6,7,8)
- Name
- Syneos Health Inc.
- Responsibilities
- Safety Database and Management
- Name
- Icon Laboratory Services Inc.
- Responsibilities
- sponsorDuties codes: 4 (laboratory services)
- Name
- Charles River Laboratories Inc.
- Responsibilities
- sponsorDuties codes: 4 (laboratory services)
- Name
- Intrinsic Lifesciences LLC
- Responsibilities
- sponsorDuties codes: 4
Third parties
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Intrinsic Lifesciences LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Safety Database and Management (sponsorDuties code: 15; value provided: 'Safety Database and Management')","organisation_type":"Pharmaceutical company"}
- {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"sponsorDuties codes: 1,15 (value 'Patient Recruitment' provided),2,5,6,7,8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Charles River Laboratories Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Rusfertide 10mg
- Active Substance
- RUSFERTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- 1
- Orphan Designation
- Yes
- Dose Levels
- 10 mg | 20 mg | 30 mg | 45 mg | 60 mg
- Maximum Dose
- 90 mg (maxDailyDoseAmount)
- Investigational Product Name
- Rusfertide 20mg
- Active Substance
- RUSFERTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- 1
- Orphan Designation
- Yes
- Dose Levels
- 10 mg | 20 mg | 30 mg | 45 mg | 60 mg
- Maximum Dose
- 90 mg (maxDailyDoseAmount)
- Investigational Product Name
- Rusfertide 30mg
- Active Substance
- RUSFERTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- 1
- Orphan Designation
- Yes
- Dose Levels
- 10 mg | 20 mg | 30 mg | 45 mg | 60 mg
- Maximum Dose
- 90 mg (maxDailyDoseAmount)
- Investigational Product Name
- Rusfertide 45mg
- Active Substance
- RUSFERTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- 1
- Orphan Designation
- Yes
- Dose Levels
- 10 mg | 20 mg | 30 mg | 45 mg | 60 mg
- Maximum Dose
- 90 mg (maxDailyDoseAmount)
- Investigational Product Name
- Rusfertide 60mg
- Active Substance
- RUSFERTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- 1
- Orphan Designation
- Yes
- Dose Levels
- 10 mg | 20 mg | 30 mg | 45 mg | 60 mg
- Maximum Dose
- 90 mg (maxDailyDoseAmount)
- Investigational Product Name
- Placebo to Match PTG-300 for Injection
- Modality
- Other
- Combination Treatment
- Yes
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