Olorofim Aspergillus Infection Study

PHASE3RecruitingINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

March 31, 2022

Primary Completion Date

September 14, 2025

Study Completion Date

November 1, 2026

Conditions
Invasive Aspergillosis
Interventions
DRUG

Olorofim

Loading Dose: 5 tablets (150 mg) to be taken twice daily at a 12-hour (± 1 hour) interval on Day 1 Maintenance Dose: 3 tablets (90 mg) to be taken twice daily at 12-hour (± 1 hour) intervals from Day 2 until Day 84 (± 7 days)

DRUG

AmBisome®

Initial course of at least 10 days of AmBisome® administered daily at a dose of 3 mg/kg by IV infusion over a 30- to 60-minute period or according to local guidelines Administration of SOC will follow international, national, or local guidelines and product labelling.

Trial Locations (140)

149

RECRUITING

Inmi Lazzaro Spallanzani Irccs, Roma

168

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma

404

RECRUITING

China Medical University Hospital, Taichung

807

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

1023

RECRUITING

Auckland City Hospital, Auckland

1070

RECRUITING

Hôpital Erasme, Brussels

2065

RECRUITING

Royal NorthShore Hospital, Saint Leonards

2089

RECRUITING

Istituto Clinico Humanitas, Rozzano

3000

RECRUITING

Universitair Ziekenhuis Gent, Ghent

RECRUITING

UZ Leuven, Leuven

3050

RECRUITING

Royal Melbourne Hospital, Parkville

3181

RECRUITING

The Alfred Hospital, Melbourne

4029

RECRUITING

Royal Brisbane & Women's Hospital, Herston

4103

TERMINATED

Universitatsklinikum Leipzig, Leipzig

6021

RECRUITING

Wellington Regional Hospital, Newtown

6129

RECRUITING

Clinica Malattie Infettive Dipartimento di Medicina e Chirurgia dell'Università, Perugia

6150

RECRUITING

Fiona Stanley Hospital, Murdoch

8000

RECRUITING

AZ Sint-Jan, Bruges

8036

RECRUITING

Hospital Clinic de Barcelona, Barcelona

10065

RECRUITING

Weill Cornell Medicine NY Presbyterian Hospital, New York

10700

RECRUITING

Siriraj Hospital, Bangkok Noi

11217

RECRUITING

Taipei Veterans General Hospital, Taipei

12203

RECRUITING

Charite Universitatsmedizin Berlin, Berlin

15232

RECRUITING

University of Pittsburgh Medical Center Health System, Pittsburgh

16132

RECRUITING

IRCCS Ospedale Policlinico San Martino, Genova

20132

RECRUITING

Ospedale San Raffaele, Milan

20162

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda, Milan

20892

RECRUITING

NIH Clinical Center ,NIAID,NIH, Bethesda

20900

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori, Monza

21280

RECRUITING

Dicle University, Medical Faculty, Diyarbakır

21287

RECRUITING

The Johns Hopkins Hospital, Baltimore

23561

TERMINATED

Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare, New Taipei City

25030

RECRUITING

CHU Besançon - Hôpital Jean Minjoz, Besançon

RECRUITING

CHU de Besancon, Besançon

27514

RECRUITING

University of North Carolina at Chapel Hill, Chapel Hill

27710

RECRUITING

Duke Department of Medicine Infectious Diseases Division, Durham

28007

RECRUITING

Hospital General Universitario Gregorio Marañón, Retiro

28034

RECRUITING

Hospital Universitario Ramon y Cajal, Madrid

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

28046

RECRUITING

Hospital Universitario La Paz, Madrid

30625

RECRUITING

UKE Universitaetsklinikum-Hamburg Eppendorf, Hamburg-Eppendorf

30912

RECRUITING

Augusta University, Augusta

31059

RECRUITING

Institut Universitaire du Cancer de Toulouse- IUCT-O, Toulouse

32610

RECRUITING

University of Florida, Gainesville

33000

RECRUITING

CHU Bordeaux Hopital Saint André, Bordeaux

34303

RECRUITING

Acibadem Atakent Hospital, Istanbul

35000

RECRUITING

CHU de Rennes - Hôpital Pontchaillou, Rennes

35100

RECRUITING

Ege University Medical Faculty, Izmir

35249

RECRUITING

University of Alabama at Birmingham, Birmingham

40002

RECRUITING

Srinagarind Hospital, Khon Kaen

41124

RECRUITING

AOU Policlinico di Modena, Modena

44093

RECRUITING

CHU de Nantes CIC Hematologie, Nantes

46026

RECRUITING

Hospital Universitari i Politecnic La Fe, Valencia

48109

RECRUITING

University of Michigan, Ann Arbor

50004

RECRUITING

The Second Hospital of Hebei Medical University, Shijiazhuang

55270

RECRUITING

Ondokuz Mayis Univ. Med. Fac., Samsun

55455

RECRUITING

University of Minnesota, Minneapolis

55905

RECRUITING

Mayo Clinic - Rochester, Rochester

56100

RECRUITING

Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello), Pisa

59037

RECRUITING

Hospital Claude Huriez, Lille

RECRUITING

Universitaetsklinikum Koeln, Cologne

60637

RECRUITING

University of Chicago Medical Center, Chicago

63110

RECRUITING

Washington University School of Medicine, St Louis

64111

RECRUITING

University of Kansas Medical Center, Kansas City

64239

RECRUITING

Tel Aviv Sourasky Medical Center Pt, Tel Aviv

67200

RECRUITING

Institut de Cancérologie de Strasbourg Europe - ICANS, Strasbourg

73104

RECRUITING

OU Health OU Medical Center, Oklahoma City

75015

RECRUITING

Hôpital Necker - Enfants Malades, Paris

77030

RECRUITING

Houston Methodist, Houston

80138

RECRUITING

Azienda Ospedaliera Universitaria Luigi Vanvitelli, Napoli

84001

RECRUITING

Soroka University Medical Center, Beersheba

89119

TERMINATED

Clairvoyant Research Group, LLC, Las Vegas

91010

RECRUITING

City of Hope National Medical Center, Duarte

94143

RECRUITING

UCSF Helen Diller Medical Center at Parnassus Heights, San Francisco

95817

RECRUITING

University of California Davis Health System, Sacramento

100033

RECRUITING

Peking University People's Hospital, Beijing

100191

RECRUITING

Peking University Third Hospital, Beijing

110055

RECRUITING

Shengjing Hospital of China Medical University, Shengyang

117599

RECRUITING

National University Hospital, Singapore

130021

RECRUITING

The First Hospital of Jilin University, Changchun

169608

RECRUITING

Singapore General Hospital- Parent, Singapore

200040

RECRUITING

Huashan Hospital Fudan University, Shanghai

230001

RECRUITING

Anhui Provincial Hospital, Hefei

233004

RECRUITING

The First Affiliated Hospital of Bengbu Medical College, Bengbu

250012

RECRUITING

Qilu Hospital of Shandong University, Jinan

300020

RECRUITING

Institute of Hematology and Blood Diseases Hospital, Xiaobailou

310003

RECRUITING

The First Affiliated Hospital of Zhejiang University school of medicine, Hangzhou

325000

RECRUITING

The 1st Affiliated Hosp of Wenzhou Medical University, Wenzhou

330006

RECRUITING

The First Affiliated Hospital of Nanchang University, Nanchang

350001

RECRUITING

Fujian Medical University Union Hospital, Fuzhou

410000

RECRUITING

Xiangya Hospital, Central South University, Changsha

423000

RECRUITING

Chenzhou No.1 People's Hospital, Chenzhou

430022

RECRUITING

Huazhong University of Science and Technology, Wuhan

450003

RECRUITING

Henan Provincial People's Hospital, Zhengzhou

510080

RECRUITING

Guangdong Provincial People's Hospital, Guangzhou

RECRUITING

The First Affiliated Hospital of Sun Yat-sen University, Guangzhou

510515

RECRUITING

Nanfang Hospital of Southern Medical University, Guangzhou

530000

RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning

710126

RECRUITING

Xi'an International Medical Center, Xi'an

1138677

RECRUITING

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Bunkyō City

3290431

RECRUITING

Saitama Medical Center Jichi Medical University, Saitama

RECRUITING

Jichi Medical University Hospital, Shimotsuke

5265601

RECRUITING

Chaim Sheba Medical Center, Ramat Gan

9112001

RECRUITING

Hadassah University Hospital - Ein Kerem, Jerusalem

02114

RECRUITING

Massachusetts General Hospital, Boston

08901

RECRUITING

Rutgers RWJMS, New Brunswick

98109-1024

RECRUITING

Fred Hutchinson Cancer Center, Seattle

30110-934

TERMINATED

Hospital Felício Rocho, Belo Horizonte

30150-221

TERMINATED

Santa Casa de Misericórdia de Belo Horizonte, Belo Horizonte

37904-020

RECRUITING

Santa Casa de Misericórdia de Passos, Passos

81520-060

RECRUITING

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer, Curitiba

90020-090

RECRUITING

Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre

90035-903

RECRUITING

Hospital de Clínicas de Porto Alegre, Porto Alegre

90610-000

RECRUITING

Hospital São Lucas da PUCRS, Porto Alegre

97105-900

RECRUITING

Hospital da Universidade Federal de Santa Maria CEP/UFSM, Santa Maria

T6G 2B7

RECRUITING

University of Alberta Hospital, Edmonton

L8L 2X2

RECRUITING

Hamilton Health Sciences - Juravinski Site, Hamilton

M5G1M1

RECRUITING

Toronto General Hospital, Toronto

M5G1N8

RECRUITING

University Health Network, Toronto

260 8677

RECRUITING

Chiba University Hospital, Chiba

812 8582

RECRUITING

Kyushu University Hospital, Fukuoka

980 8574

RECRUITING

Tohoku University Hospital, Sendai

541 8567

RECRUITING

Osaka International Cancer Institute, Osaka

545 8586

RECRUITING

Osaka Metropolitan University Hospital, Osaka

589 8511

RECRUITING

Kindai University Hospital, Ōsaka-sayama

105-8471

RECRUITING

The Jikei University Hospital, Minato-Ku

105 8470

RECRUITING

Toranomon Hospital, Minatoku

852 8501

RECRUITING

Nagasaki University Hospital, Nagasaki

700 8558

RECRUITING

Okayama University Hospital, Okayama

6525GA

RECRUITING

Radboud Nijmegen, Nijmegen

3508 GA

RECRUITING

UMC Utrecht, Utrecht

06591

RECRUITING

The Catholic University of Korea, Bucheon-si

06351

RECRUITING

Samsung Medical Center, Irwon-dong

08035

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

Unknown

RECRUITING

National Taiwan University Hospital, Taipei

06100

RECRUITING

Hacettepe University Medical Faculty, Ankara

06800

RECRUITING

Ankara City Hospital, Ankara

CF14 4XW

RECRUITING

University Hospital of Wales, Cardiff

SE5 9RS

RECRUITING

Kings College Hospital, London

W6 8RP

RECRUITING

Imperial College London, London

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Iqvia Pty Ltd

INDUSTRY

collaborator

Shionogi

INDUSTRY

lead

F2G Biotech GmbH

INDUSTRY