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A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
- Respiratory Disorder
- Idiopathic Pulmonary Fibrosis (IPF)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Terminated
This trial runs in
Cities
- Adana
- Akershus
- Ankara
- Antalya
- Ashkelon
- Athens
- Auckland
- Badalona
- Barcelona
- Be'er Sheva
- Be'er Ya'akov
- bei-jing-shi
- Beijing
- Bergen
- Berlin
- Birmingham
- Bobigny
- Bordeaux
- Boston
- Braga
- Brandon
- Brest
- Brno-Bohunice
- Bron
- Bruxelles
- Bucheon
- Budapest
- Buenos Aires
- Bursa
- Bydgoszcz
- Cairns North
- Camperdown
- Cape Town
- Catania
- celebration
- Cesi
- Chaidari
- chang-sha-shi
- Chesterfield
- chiayi-city
- Chiba
- Chihuahua
- Christchurch
- Chuo City
- Ciudad de México
- Clayton
- Columbia
- Coslada
- Córdoba
- Daytona Beach
- Debrecen
- Denver
- Dijon
- Evanston
- Falls Church
- Firenze
- Florida
- Foggia
- Forlì
- Fukuoka
- Galdakao
- Galveston
- gasteiz
- Gaziantep
- Granada
- Greensboro
- Guimaraes
- Haifa
- Hamilton
- Heidelberg
- Hellerup
- highgate-hill
- Himeji
- Hlavní město Praha
- Holon
- Hong Kong Island
- Immenhausen
- Incheon
- Iowa City
- Iraklio
- İstanbul
- İzmir
- Jacksonville
- Jerusalem
- kamogawa
- Kansas City
- Kaohsiung City
- Kawasaki
- Kayseri
- Kefar Sava
- Kelowna
- Kobe
- Kocaeli
- Kumamoto
- Kurashiki
- L'Hospitalet de Llobregat
- La Tronche
- Leuven
- Lille
- Lisboa
- Liège
- Louisville
- loxahatchee-groves
- Madrid
- Mar del Plata
- Marburg
- Marousi
- Marseille
- McKinney
- Melbourne
- Mendoza
- Mersin
- Milano
- Minneapolis
- Modena
- Monza
- Morelia
- Málaga
- Münnerstadt
- Nagasaki
- Napoli
- Nashville
- Neochoropoulo
- New Haven
- New Taipei City
- New Territories
- New York
- Nice
- Nieuwegein
- North Charleston
- Odense
- Omaha
- Oslo
- Oviedo
- Owen Sound
- Padova
- Palermo
- Paris
- Patras
- Pavia
- Petah Tikva
- Philadelphia
- Pilar Centro
- Pittsburgh
- Portland
- Ramat Gan
- Rehovot
- Reims
- Rennes
- Richmond
- Rochester
- Roma
- Rosario
- Rotterdam
- Sabadell
- Sacramento
- Sakai
- Salamanca
- Salt Lake City
- San Diego
- San Francisco
- San Miguel de Tucumán
- san-nicolas-de-los-garza
- Santander
- Santiago de Compostela
- Sassari
- Seongnam-si
- Seoul
- seto
- shen-yang-shi
- Sherwood Park
- Shijiazhuang
- Shimotsuke
- Shinjuku City
- Siena
- Singapore
- Solingen
- Spartanburg
- St. Louis
- Szombathely
- Taichung City
- Tainan City
- Taipei City
- Tatabánya
- Tauranga
- Tel Aviv-Yafo
- tenri
- tian-jin-shi
- Tokai
- Tokushima
- Tours
- Treviso
- Trois-Rivières
- Törökbálint
- València
- Vila Nova de Gaia
- Volos
- Washington
- wesley-chapel
- Wilmington
- Windsor
- Winter Park
- Woolloongabba
- wu-han-shi
- wu-xi-shi
- Yokohama
- Yvoir
- zheng-zhou-shi
- Łódź
- Πειραιας
- 横浜市
Trial Identifier:
NCT04594707 2020-001429-30 WA42294
Trial Summary
This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04594707, WA42294, 2020-001429-30
Trial Identifier
PRM-151 (Zinpentraxin Alfa)
Treatments
Idiopathic Pulmonary Fibrosis
Condition
Official Title
A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Eligibility Criteria
All
Gender
No
Healthy Volunteers
Inclusion Criteria
- Taken part in either of the prior PRM-151 studies: PRM-151-202 or WA42293.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
Exclusion Criteria
- Acute respiratory or systemic bacterial, viral, or fungal infection at the first visit of the OLE, or within 2 weeks of the first visit for patients joining Cohort A (from Study PRM-151-202).
- History of smoking within 3 months prior to the first visit in the OLE.
- History of alcohol or substance use disorder within 2 years prior to the first visit of the OLE or known or suspected active alcohol or substance-use disorder.
- History of severe allergic reaction or anaphylactic reaction to PRM-151.
- Clinically significant abnormality on ECG during eligibility assessment that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.
- Prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) based on the Fridericia correction formula.
- Clinically significant laboratory test abnormalities (hematology, serumchemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.
For the latest version of this information please go to www.forpatients.roche.com