Clinical trial • Phase III • Cardiology|Rare Disease

RALINEPAG for Pulmonary arterial hypertension

Phase III trial of RALINEPAG for Pulmonary arterial hypertension. open-label, none/not specified-controlled. 419 participants.

Overview

Trial Therapeutic Area
Cardiology|Rare Disease
Trial Disease
Pulmonary arterial hypertension
Trial Stage
Phase III
Drug Modality
Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
10-05-2024
First CTIS Authorization Date
19-06-2024

Trial design

open-label, none/not specified-controlled Phase III trial across 47 sites in Spain, Bulgaria, Netherlands and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
419
Trial Duration For Participant
2190

Eligibility

Recruits 419 The record indicates vulnerable population selection (isVulnerablePopulationSelected = true). Informed consent must be documented as "Evidence of a personally signed and dated Informed Consent Form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures." Specific consent materials include Pregnant Partner Consent ICF documents in addition to main ICFs; multiple country/language specific ICFs are provided. No specific assent procedures for minors are described in the provided materials..

Pregnancy Exclusion
Female subjects who wish to become pregnant or who have a positive pregnancy test on Day 1 (OLE Entry Visit). Women who are pregnant, lactating, or breastfeeding
Vulnerable Population
The record indicates vulnerable population selection (isVulnerablePopulationSelected = true). Informed consent must be documented as "Evidence of a personally signed and dated Informed Consent Form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures." Specific consent materials include Pregnant Partner Consent ICF documents in addition to main ICFs; multiple country/language specific ICFs are provided. No specific assent procedures for minors are described in the provided materials.

Inclusion criteria

  • {"criterion_text":"- Evidence of a personally signed and dated Informed Consent Form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures.\n- Subjects who are willing and able to comply with scheduled clinic visits, treatment plans, laboratory tests, and other study procedures.\n- Completed the protocol-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study.\n- Both male and female subjects agree to use a highly effective method of birth control throughout the entire study period from informed consent through the 30-Day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process (ie, actively attempt to become pregnant or to impregnate, in vitro fertilization) during the study and for 30 days after the last dose of ralinepag. Eligible male subjects must agree not to participate in sperm donation for 90 days after the last dose of ralinepag."}

Exclusion criteria

  • {"criterion_text":"- Subjects who prematurely discontinued ralinepag due to a drug-related AE/SAE or tolerability issue in the preceding ralinepag study in which they were enrolled, or subjects who did not complete all protocol-defined study procedures at a Study Drug Termination Visit or End of Study Visit in the preceding ralinepag study.\n- Subjects who withdrew consent during participation in another ralinepag study.\n- Female subjects who wish to become pregnant or who have a positive pregnancy test on Day 1 (OLE Entry Visit).\n- Women who are pregnant, lactating, or breastfeeding\n- Subjects who have undergone lung or heart/lung transplant or the initiation of long-term (>12 weeks) parenteral (intravenous or subcutaneous infusion) or inhaled therapy with a prostacyclin or oral therapy with another IP receptor agonist during the time since participation in their original ralinepag study.\n- Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 study.\n- Known hypersensitivity to ralinepag or any of the excipients.\n- Any reason that, in the opinion of the Investigator or Medical Monitor, precludes the subject from participating in the study, eg, noncompliance concerns, any previous or intercurrent medical condition that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Efficacy assessments will include an evaluation of: •\tNT-proBNP •\t6MWD •\tWHO/NYHA FC •\tThe proportion of subjects who achieve all 3 of the following (at specified time points): o\tNT-proBNP level <300 pg/mL o\t6MWD >440 meters o\tWHO/NYHA FC II status or better •\tHRQoL measures (where validated) •\tTime to all-cause hospitalization during the study period •\tTime to all-cause mortality during the study period","definition_or_measurement_approach":"NT-proBNP measured as N-terminal pro-brain natriuretic peptide; 6MWD = 6-Minute Walk Distance measured in meters; WHO/NYHA FC = WHO/New York Heart Association Functional Class; composite proportion defined as achieving NT-proBNP <300 pg/mL AND 6MWD >440 meters AND WHO/NYHA FC II status or better at specified time points; HRQoL by validated health-related quality-of-life instruments; time-to-event endpoints measured as time to all-cause hospitalization and time to all-cause mortality during study period."}

Recruitment

Planned Sample Size
419
Recruitment Window Months
89
Consent Approach
Evidence of a personally signed and dated Informed Consent Form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures. Subject information and informed consent forms (Main ICF) and Pregnancy/Pregnant Partner consent forms are provided; multiple language versions are available (e.g. English, Bulgarian, French, Spanish, German, Italian, Portuguese, Hungarian, Polish, Dutch, Czech, Greek, Romanian and others as per submitted ICF documents). No assent procedures for minors are specified in the available materials.

Geography

Total Number Of Sites
47
Total Number Of Participants
156

Spain

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
20-06-2024
Processing Time Days
28
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Pneumology Department
Principal Investigator Name
Joan Albert Barberá Mir
Principal Investigator Email
jbarbera@clinic.ub.es
Contact Person Name
Joan Albert Barberá Mir
Contact Person Email
jbarbera@clinic.ub.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Pneumology Department
Principal Investigator Name
Raquel López Reyes
Principal Investigator Email
raquel.lopez@separ.es
Contact Person Name
Raquel López Reyes
Contact Person Email
raquel.lopez@separ.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Cardiology Department
Principal Investigator Name
Pilar Escribano Subias
Principal Investigator Email
pilar.escribano@telefonica.net
Contact Person Name
Pilar Escribano Subias
Contact Person Email
pilar.escribano@telefonica.net

Bulgaria

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
02-07-2024
Processing Time Days
40
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
MHAT National Heart Hospital EAD
Department Name
Clinic of Cardiology
Principal Investigator Name
Borislav Georgiev
Principal Investigator Email
b.georgiev@abv.bg
Contact Person Name
Borislav Georgiev
Contact Person Email
b.georgiev@abv.bg
Site Name
University Hospital St. Anna
Department Name
Clinic of Cardiology
Principal Investigator Name
Vasil Velchev
Principal Investigator Email
velchevvasil@gmail.com
Contact Person Name
Vasil Velchev
Contact Person Email
velchevvasil@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
19-06-2024
Processing Time Days
27
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
VUmc Stichting
Department Name
Department of Pulmonary Medicine
Principal Investigator Name
Antonie Vonk Noordegraaf
Principal Investigator Email
a.vonk@vumc.nl
Contact Person Name
Antonie Vonk Noordegraaf
Contact Person Email
a.vonk@vumc.nl

France

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
24-06-2024
Processing Time Days
32
Number Of Sites
5
Number Of Participants
17

Sites

Site Name
Hospices Civils De Lyon
Department Name
Pneumology
Principal Investigator Name
Vincent COTTIN
Principal Investigator Email
vincent.cottin@chu-lyon.fr
Contact Person Name
Vincent COTTIN
Contact Person Email
vincent.cottin@chu-lyon.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Pneumology
Principal Investigator Name
Matthieu CANUET
Principal Investigator Email
matthieu.canuet@chru-strasbourg.fr
Contact Person Name
Matthieu CANUET
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Internal medicine and pulmonology department
Principal Investigator Name
Francis COUTURAUD
Principal Investigator Email
francis.couturaud@chu-brest.fr
Contact Person Name
Francis COUTURAUD
Contact Person Email
francis.couturaud@chu-brest.fr
Site Name
CHRU De Nancy
Department Name
Pneumology
Principal Investigator Name
Ari CHAOUAT
Principal Investigator Email
a.chaouat@chru-nancy.fr
Contact Person Name
Ari CHAOUAT
Contact Person Email
a.chaouat@chru-nancy.fr
Site Name
CHU De Rouen
Department Name
Pneumology, Thoracic Oncology and Respiratory Intensive Care Department
Principal Investigator Name
Elise ARTAUD-MACARI
Principal Investigator Email
elise.artaud-macari@chu-rouen.fr
Contact Person Name
Elise ARTAUD-MACARI

Poland

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
60
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddział Kardiologii
Principal Investigator Name
Tatiana Mularek-Kubzdela
Principal Investigator Email
tatianamularek@wp.pl
Contact Person Name
Tatiana Mularek-Kubzdela
Contact Person Email
tatianamularek@wp.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Klinika Kardiologii z O. Intensywnego Nadzoru
Principal Investigator Name
Karol Kamiński
Principal Investigator Email
fizklin@wp.pl
Contact Person Name
Karol Kamiński
Contact Person Email
fizklin@wp.pl
Site Name
Premium Clinic Wrocław CM
Principal Investigator Name
Ewa Mroczek
Principal Investigator Email
mroczeke@wp.pl
Contact Person Name
Ewa Mroczek
Contact Person Email
mroczeke@wp.pl

Italy

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
24-06-2024
Processing Time Days
32
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Cardiology
Principal Investigator Name
Stefano Ghio
Principal Investigator Email
s.ghio@smatteo.pv.it
Contact Person Name
Stefano Ghio
Contact Person Email
s.ghio@smatteo.pv.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Cardiology
Principal Investigator Name
Pietro Ameri
Principal Investigator Email
pietroameri@unige.it
Contact Person Name
Pietro Ameri
Contact Person Email
pietroameri@unige.it
Site Name
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. I.S.M.E.T.T. S.r.L
Department Name
Cardiology
Principal Investigator Name
Patrizio Vitulo
Principal Investigator Email
pvitulo@ismett.edu
Contact Person Name
Patrizio Vitulo
Contact Person Email
pvitulo@ismett.edu
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Cardiology
Principal Investigator Name
Roberto Badagliacca
Principal Investigator Email
robero.badagliacca@uniroma1.it
Contact Person Name
Roberto Badagliacca
Contact Person Email
robero.badagliacca@uniroma1.it

Czechia

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
20-06-2024
Processing Time Days
28
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
II. interní klinika kardiologie a angiologie VFN a 1.LF UK, Centrum pro plicní hypertenzi
Principal Investigator Name
Pavel Jansa
Principal Investigator Email
pavel.jansa@vfn.cz
Contact Person Name
Pavel Jansa
Contact Person Email
pavel.jansa@vfn.cz

Romania

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
25-06-2024
Processing Time Days
33
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara
Department Name
Sectia 2 Pneumologie
Principal Investigator Name
Ovidiu Fira-Mladinescu
Principal Investigator Email
mladinescu@umft.ro
Contact Person Name
Ovidiu Fira-Mladinescu
Contact Person Email
mladinescu@umft.ro
Site Name
Institutul Inimii De Urgenta Pentru Boli Cardiovasculare Niculae Stancioiu
Department Name
Sectia Cardiologie I
Principal Investigator Name
Stefan Dan Cezar Mot
Principal Investigator Email
motstefan@gmail.com
Contact Person Name
Stefan Dan Cezar Mot
Contact Person Email
motstefan@gmail.com
Site Name
Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu
Department Name
Sectia Cardiologie II
Principal Investigator Name
Ioan Mircea Coman
Principal Investigator Email
iocoman@yahoo.com
Contact Person Name
Ioan Mircea Coman
Contact Person Email
iocoman@yahoo.com
Site Name
Institutul De Pneumoftiziologie Marius Nasta
Department Name
Sectia 4 Pneumologie
Principal Investigator Name
Claudia Lucia Toma
Principal Investigator Email
claudiatoma@yahoo.co.uk
Contact Person Name
Claudia Lucia Toma
Contact Person Email
claudiatoma@yahoo.co.uk

Hungary

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
19-06-2024
Processing Time Days
27
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
University Of Szeged
Department Name
Családorvosi Intézet és Rendelő
Principal Investigator Name
Albert Varga
Principal Investigator Email
varga.albert@med.u-szeged.hu
Contact Person Name
Albert Varga
Contact Person Email
varga.albert@med.u-szeged.hu
Site Name
Gottsegen National Cardiovascular Center
Department Name
-
Principal Investigator Name
Olga Hajnalka Bálint
Principal Investigator Email
titkarsag@kardio.hu
Contact Person Name
Olga Hajnalka Bálint
Contact Person Email
titkarsag@kardio.hu
Site Name
University Of Pecs
Department Name
Szívgyógyászati Klinika
Principal Investigator Name
András Komócsi
Principal Investigator Email
andras.komocsi@aok.pte.hu
Contact Person Name
András Komócsi
Contact Person Email
andras.komocsi@aok.pte.hu

Germany

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
20-06-2024
Processing Time Days
28
Number Of Sites
7
Number Of Participants
21

Sites

Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Zentrum für Pulmolare Hypertonie
Principal Investigator Name
Ekkehard Gruenig
Principal Investigator Email
ekkehard.gruenig@med.uni-heidelberg.de
Contact Person Name
Ekkehard Gruenig
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik I
Principal Investigator Name
Michael Halank
Principal Investigator Email
michael.halank@uniklinikum-dresden.de
Contact Person Name
Michael Halank
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Innere Medizin V
Principal Investigator Name
Heinrike Wilkens
Principal Investigator Email
heinrike.wilkens@uks.eu
Contact Person Name
Heinrike Wilkens
Contact Person Email
heinrike.wilkens@uks.eu
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Klinik und Poliklinik für Innere Medizin B
Principal Investigator Name
Ralf Ewert
Principal Investigator Email
ralf.ewert@med.uni-greifswald.de
Contact Person Name
Ralf Ewert
Site Name
Universitaet Leipzig
Department Name
Medizinische Klinik II
Principal Investigator Name
Hubert Wirtz
Principal Investigator Email
hubert.wirtz@medizin.uni-leipzig.de
Contact Person Name
Hubert Wirtz
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
II. Medizinische Klinik und Poliklinik
Principal Investigator Name
Hans F. E. Klose
Principal Investigator Email
klose@uke.de
Contact Person Name
Hans F. E. Klose
Contact Person Email
klose@uke.de
Site Name
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Department Name
Lungenzentrum
Principal Investigator Name
Hinrich-Cordt Bremer
Principal Investigator Email
hinrich.bremer@sbk-vs.de
Contact Person Name
Hinrich-Cordt Bremer
Contact Person Email
hinrich.bremer@sbk-vs.de

Portugal

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
02-07-2024
Processing Time Days
40
Number Of Sites
4
Number Of Participants
17

Sites

Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
Cardiology
Principal Investigator Name
Filipa Ferreira
Principal Investigator Email
filipa.ferreira@hgo.min-saude.pt
Contact Person Name
Filipa Ferreira
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Cardiology
Principal Investigator Name
Maria da Graça Castro
Principal Investigator Email
castro2406@gmail.com
Contact Person Name
Maria da Graça Castro
Contact Person Email
castro2406@gmail.com
Site Name
Centro Hospitalar Universitario De Santo Antonio E.P.E.
Department Name
Cardiology
Principal Investigator Name
Fabienne Gonçalves
Contact Person Name
Fabienne Gonçalves
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Cardiology
Principal Investigator Name
Rui Plácido
Principal Investigator Email
placidorui@gmail.com
Contact Person Name
Rui Plácido
Contact Person Email
placidorui@gmail.com

Greece

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
60
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
A' Cardiology Clinic
Principal Investigator Name
George Giannakoulas
Principal Investigator Email
g.giannakoulas@gmail.com
Contact Person Name
George Giannakoulas
Contact Person Email
g.giannakoulas@gmail.com
Site Name
Onassis Cardiac Surgery Center
Department Name
Hemodynamic Research and Interventional Cardiology
Principal Investigator Name
Vassilios Voudris
Principal Investigator Email
vvoudris@otenet.gr
Contact Person Name
Vassilios Voudris
Contact Person Email
vvoudris@otenet.gr
Site Name
University General Hospital Of Alexandroupoli
Department Name
University Cardiology Clinic
Principal Investigator Name
Stavros Konstantinides
Principal Investigator Email
skonst@med.duth.gr
Contact Person Name
Stavros Konstantinides
Contact Person Email
skonst@med.duth.gr

Denmark

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
19-06-2024
Processing Time Days
27
Number Of Sites
2
Number Of Participants
13

Sites

Site Name
Aarhus Universitetshospital
Department Name
Department of Cardiology
Principal Investigator Name
Søren Mellemkjær
Principal Investigator Email
soren.mellemkjaer@rm.dk
Contact Person Name
Søren Mellemkjær
Contact Person Email
soren.mellemkjaer@rm.dk
Site Name
Rigshospitalet
Department Name
Department of Cardiology
Principal Investigator Name
Jørn Carlsen
Principal Investigator Email
joern.carlsen@regionh.dk
Contact Person Name
Jørn Carlsen
Contact Person Email
joern.carlsen@regionh.dk

Austria

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
24-06-2024
Processing Time Days
32
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
Division of Internal Medicine II
Principal Investigator Name
Judith Loeffler-Ragg
Principal Investigator Email
judith.loeffler@i-med.ac.at
Contact Person Name
Judith Loeffler-Ragg
Contact Person Email
judith.loeffler@i-med.ac.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Ordensklinikum Linz Elisabethinen, Internal II - Cardiology, Angiology & Intensive Care Medicine
Principal Investigator Name
Regina Steringer-Mascherbauer
Contact Person Name
Regina Steringer-Mascherbauer
Site Name
Medical University Of Vienna
Department Name
Division of Internal Medicine II, Dept. of
Principal Investigator Name
Irene Marthe Lang
Principal Investigator Email
irene.lang@meduniwien.ac.at
Contact Person Name
Irene Marthe Lang
Contact Person Email
irene.lang@meduniwien.ac.at

Belgium

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
21-06-2024
Processing Time Days
29
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Hopital Erasme
Department Name
Pneumology
Principal Investigator Name
Jean-Luc Vachiery
Principal Investigator Email
jeanluc.vachiery@erasme.ulb.ac.be
Contact Person Name
Jean-Luc Vachiery
Site Name
UZ Leuven
Department Name
Pneumology
Principal Investigator Name
Marion Delcroix
Principal Investigator Email
marion.delcroix@uzleuven.be
Contact Person Name
Marion Delcroix
Contact Person Email
marion.delcroix@uzleuven.be

Sponsor

Primary sponsor

Full Name
United Therapeutics Corp.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Syneos Health Netherlands B.V.
Responsibilities
Expedited and periodic safety reporting (for Spain only expediated reporting); code: 8
Name
IQVIA Limited
Responsibilities
Roles including regulatory and safety activities (codes: 1,12,13,15 with periodic safety reporting for Spain; codes 5,8)
Name
IQVIA RDS Hellas Single Member S.A.
Responsibilities
Regulatory Applications in Greece; other sponsor duties (codes: 1,8,15)
Name
Eresearchtechnology Inc.
Responsibilities
ECG analysis/ review (code:15)
Name
Q Squared Solutions Limited
Responsibilities
Sponsor duty code: 4
Name
Labcorp Early Development Laboratories Inc.
Responsibilities
Sponsor duty code: 4

Third parties

  • {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"Expedited and periodic safety reporting (for Spain only expediated reporting); code: 8","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Codes: 1, 12, 13, 15 (Periodic safety reporting for Spain), 5, 8","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"Codes: 1, 15 (Regulatory Applications in Greece), 8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"15 (ECG analysis/ review)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Ralinepag
Active Substance
RALINEPAG
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised
Orphan Designation
Yes
Maximum Dose
9000 µg per day
Investigational Product Name
Ralinepag
Active Substance
RALINEPAG
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised
Orphan Designation
Yes
Maximum Dose
9000 µg per day
Investigational Product Name
Ralinepag
Active Substance
RALINEPAG
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised
Orphan Designation
Yes
Maximum Dose
9000 µg per day
Investigational Product Name
Ralinepag
Active Substance
RALINEPAG
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised
Orphan Designation
Yes
Maximum Dose
9000 µg per day

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