search
Back to results

A Phase III Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors. (COMMODORE 2)

Primary Purpose

Paroxysmal Nocturnal Hemoglobinuria

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Crovalimab
Eculizumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Nocturnal Hemoglobinuria

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body weight >= 40 kg at screening.
  • Willingness and ability to comply with all study visits and procedures.
  • Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry.
  • LDH level >= 2x ULN at screening (as per local assessment).
  • Vaccination against Neisseria meningitidis serotypes A, C, W, < 3 years prior to initiation of study treatment; or, if not previously done, vaccination administered no later than one week after the first drug administration.
  • Women of childbearing potential: agreement to remain abstinent or use contraception during the treatment period and for 10.5 months after the final dose of crovalimab or for 3 months after the final dose of eculizumab (or longer if required by the local product label).

Exclusion Criteria:

  • Current or previous treatment with a complement inhibitor.
  • History of allogeneic bone marrow transplantation.
  • History of Neisseria meningitidis infection within 6 months prior to screening and up to first study drug administration.
  • History of myelodysplastic syndrome with Revised International Prognostic Scoring System (IPSS-R) prognostic risk categories of intermediate, high and very high.
  • Pregnant or breastfeeding, or intending to become pregnant during the study, within 10.5 months after the final dose of crovalimab, or 3 months after the final dose of eculizumab (or longer if required by the local product label).
  • Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever is greater.
  • Concurrent disease, treatment, procedure or surgery, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the participant, or would, in the opinion of the Investigator, preclude the participant's safe participation in and completion of the study.
  • Splenectomy < 6 months before screening.
  • Positive for Active Hepatitis B and C infection (HBV/HCV).
  • History of or ongoing cryoglobulinemia at screening.

Sites / Locations

  • Organizacion Medica de Investigacion (OMI)
  • Liverpool Hospital
  • Centro Integrado de Oncologia de Curitiba
  • Hospital de Clínicas de Porto Alegre X
  • *X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
  • Beneficencia Portuguesa de Sao Paulo
  • Peking Union Medical College Hospital
  • Nanfang Hospital, Southern Medical University
  • The First Affiliated Hospital, Zhejiang University
  • Jiangsu Province Hospital
  • Affiliated Hospital of Nantong University; Nephrology
  • Huashan Hospital, Fudan University
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Hopital Claude Huriez - CHU Lille
  • Centre Hospitalier Lyon Sud
  • Universitaetsklinkm
  • Universitaetsklinikum Ulm
  • General Hospital of Thessaloniki G. Papanikolaou
  • The Chinese University of Hong Kong; Department of Medicine & Therapeutics
  • Sapporo Medical University Hospital
  • University of Tsukuba Hospital
  • NTT Medical Center Tokyo
  • Tokyo Medical University Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Vilnius University Hospital Santariskiu Clinics, Public Institution; Cardiology
  • Hospital Tengku Ampuan Afzan
  • Hospital Raja Permaisuri Bainun
  • Hospital Ampang
  • Hospital Pulau Pinang
  • Global Trial Research Center S.A. de C.V.
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Amsterdam UMC, Locatie AMC
  • Mary Mediatrix Medical Center
  • Philippine General Hospital; Pulmonary Medicine
  • St Lukes Medical Center
  • Szpital Uniwersytecki nr2 im. dr J. Biziela
  • Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii
  • Samodzielny Publiczny Szpital Kliniczny nr 1
  • Centrum Medyczne Pratia Poznan
  • MTZ Clinical Research Powered by Pratia
  • Centro Hospitalar do Baixo Vouga E.P.E. - Hospital de Aveiro
  • Centro Hospitalar de Lisboa Central - Hospital D. Estefânia; Pediatrics
  • Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
  • Centro Hospitalar do Porto - Hospital de Santo António
  • Spitalul Universitar de Urgenta Bucuresti
  • Spitalul Clinic Municipal Filantropia Craiova
  • National University Hospital
  • Singapore General Hospital; Department of Haematology
  • ICO Badalona - Hospital Universitari Germans Trias i Pujol; Hematologia Clinica
  • Hospital Universitario de Gran Canaria Doctor Negrín; Servicio de Hematología
  • Hospital de Basurto
  • Hospital Clinic de Barcelona
  • Hospital San Pedro de Alcantara
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario La Paz
  • Hospital Universitario Clinico San Carlos
  • Hospital Universitario de Salamanca
  • Akademiska Sjukhuset
  • Chang Gung Medical Foundation - Kaohsiung; Oncology
  • National Taiwan Universtiy Hospital; Division of Hematology
  • King Chulalongkorn Memorial Hospital
  • Siriraj Hospital
  • Maharaj Nakorn Chiang Mai Hospital
  • Ondokuz Mayis Univ. Med. Fac.
  • Medical Center OK!Clinic+
  • Mykolayiv Regional Hospital
  • St James University Hospital
  • Kings College Hospital; Kings Clinical Research Facility

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Arm A (Crovalimab)

Arm B (Eculizumab)

Arm C (Crovalimab) (Exploratory)

Arm Description

Adult Participants will receive an initial intravenous (IV) loading dose on Week 1 Day 1, followed by 4 weekly crovalimab subcutaneous (SC) doses on Week 1 Day 2, then on Weeks 2, 3 and 4. Maintenance dosing will begin at Week 5 and will continue Q4W (every 4 weeks) thereafter, for a total of at least 24 weeks of study treatment.

Adult Participants will receive initial IV weekly doses for 4 weeks which will be followed by Q2W (every 2 weeks) IV administrations starting on Week 5.

Paediatric participants will receive a loading series of Crovalimab comprised of an IV dose on Week 1 Day 1, followed by weekly crovalimab SC doses for 4 weeks on Week 1 (Day 2) then on Weeks 2, 3, and 4. Maintenance SC dosing will begin at Week 5 and will be administered Q4W thereafter. After 24 weeks of crovalimab treatment, participants who derive benefit from the drug may continue to receive crovalimab.

Outcomes

Primary Outcome Measures

Percentage of Participants who achieve Transfusion Avoidance (TA)
TA is defined as patients who are packed Red Blood Cell (pRBC) transfusion-free and do not require transfusion per protocol-specified guidelines.
Percentage of Participants with hemolysis control
Measured by LDH =< 1.5 x ULN (as measured at the central laboratory).

Secondary Outcome Measures

Percentage of Participants with Breakthrough Hemolysis (BTH)
BTH is defined as at least one new or worsening symptom or sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, shortness of breath [dyspnea], anemia [hemoglobin < 10 g/dL], a major adverse vascular event [MAVE; including thrombosis], dysphagia, or erectile dysfunction) in the presence of elevated LDH >= 2 x ULN after prior reduction of LDH to =<1.5 x ULN on treatment.
Percentage of Participants with Stabilization of Hemoglobin
Stabilized hemoglobin is defined as avoidance of a >= 2 g/dL decrease in hemoglobin level from baseline, in the absence of transfusion.
Mean Change in Fatigue
Assessed by the FACIT-Fatigue Questionnaire.
Percentage of Participants with Adverse Events (AEs)
Determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.
Percentage of Participants with Injection-Site Reactions, Infusion-Related Reactions, Hypersensitivity and Infections (including meningococcal meningitis)
Percentage of Participants with Adverse Events (AEs) leading to Study Drug Discontinuation
Percentage of Participants with clinical manifestations of Drug-Target-Drug Complex (DTDC) formation amongst those participants who switched to crovalimab treatment from eculizumab treatment
Serum concentrations of crovalimab and eculizumab over time
Percentage of Participants with Anti-Crovalimab Antibodies
Change in PD biomarkers including complement activity (CH50) over time
Assessed by a Liposome Immunoassay (LIA) and total C5 concentration
Change over time in free C5 concentration in crovalimab-treated participants
Observed Value in Reticulocyte Count (count/mL)
Observed Value in Free Hemoglobin and Haptoglobin (mg/dL)
Change in Reticulocyte Count (count/mL)
Change in Free Hemoglobin and Haptoglobin (mg/dL)

Full Information

First Posted
June 3, 2020
Last Updated
August 29, 2023
Sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical
search

1. Study Identification

Unique Protocol Identification Number
NCT04434092
Brief Title
A Phase III Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors.
Acronym
COMMODORE 2
Official Title
A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
November 16, 2022 (Actual)
Study Completion Date
June 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH who have not been previously treated with complement inhibitor therapy. This study will enroll approximately 200 participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Nocturnal Hemoglobinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (Crovalimab)
Arm Type
Experimental
Arm Description
Adult Participants will receive an initial intravenous (IV) loading dose on Week 1 Day 1, followed by 4 weekly crovalimab subcutaneous (SC) doses on Week 1 Day 2, then on Weeks 2, 3 and 4. Maintenance dosing will begin at Week 5 and will continue Q4W (every 4 weeks) thereafter, for a total of at least 24 weeks of study treatment.
Arm Title
Arm B (Eculizumab)
Arm Type
Active Comparator
Arm Description
Adult Participants will receive initial IV weekly doses for 4 weeks which will be followed by Q2W (every 2 weeks) IV administrations starting on Week 5.
Arm Title
Arm C (Crovalimab) (Exploratory)
Arm Type
Experimental
Arm Description
Paediatric participants will receive a loading series of Crovalimab comprised of an IV dose on Week 1 Day 1, followed by weekly crovalimab SC doses for 4 weeks on Week 1 (Day 2) then on Weeks 2, 3, and 4. Maintenance SC dosing will begin at Week 5 and will be administered Q4W thereafter. After 24 weeks of crovalimab treatment, participants who derive benefit from the drug may continue to receive crovalimab.
Intervention Type
Drug
Intervention Name(s)
Crovalimab
Intervention Description
Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 and 100kg) or 1500 mg IV (for participants with body weight >=100kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight between 40 and 100kg) or 1020 mg SC (for participants with body weight >=100kg). Dosing schedule will be as described above.
Intervention Type
Drug
Intervention Name(s)
Eculizumab
Intervention Description
Eculizumab will be administered at a dose of 600 mg for the first 4 weeks, followed by maintenance doses of 900 mg starting on Week 5, as per the dosing schedule described above.
Primary Outcome Measure Information:
Title
Percentage of Participants who achieve Transfusion Avoidance (TA)
Description
TA is defined as patients who are packed Red Blood Cell (pRBC) transfusion-free and do not require transfusion per protocol-specified guidelines.
Time Frame
Baseline through Week 25
Title
Percentage of Participants with hemolysis control
Description
Measured by LDH =< 1.5 x ULN (as measured at the central laboratory).
Time Frame
Week 5 through Week 25
Secondary Outcome Measure Information:
Title
Percentage of Participants with Breakthrough Hemolysis (BTH)
Description
BTH is defined as at least one new or worsening symptom or sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, shortness of breath [dyspnea], anemia [hemoglobin < 10 g/dL], a major adverse vascular event [MAVE; including thrombosis], dysphagia, or erectile dysfunction) in the presence of elevated LDH >= 2 x ULN after prior reduction of LDH to =<1.5 x ULN on treatment.
Time Frame
Baseline through Week 25
Title
Percentage of Participants with Stabilization of Hemoglobin
Description
Stabilized hemoglobin is defined as avoidance of a >= 2 g/dL decrease in hemoglobin level from baseline, in the absence of transfusion.
Time Frame
Baseline through Week 25
Title
Mean Change in Fatigue
Description
Assessed by the FACIT-Fatigue Questionnaire.
Time Frame
Baseline up to Week 25
Title
Percentage of Participants with Adverse Events (AEs)
Description
Determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.
Time Frame
Up to 7 years
Title
Percentage of Participants with Injection-Site Reactions, Infusion-Related Reactions, Hypersensitivity and Infections (including meningococcal meningitis)
Time Frame
Up to 7 years
Title
Percentage of Participants with Adverse Events (AEs) leading to Study Drug Discontinuation
Time Frame
Up to 7 years
Title
Percentage of Participants with clinical manifestations of Drug-Target-Drug Complex (DTDC) formation amongst those participants who switched to crovalimab treatment from eculizumab treatment
Time Frame
Up to 6.5 years
Title
Serum concentrations of crovalimab and eculizumab over time
Time Frame
Up to 6.5 years
Title
Percentage of Participants with Anti-Crovalimab Antibodies
Time Frame
Up to 6.5 years
Title
Change in PD biomarkers including complement activity (CH50) over time
Description
Assessed by a Liposome Immunoassay (LIA) and total C5 concentration
Time Frame
Up to 6.5 years
Title
Change over time in free C5 concentration in crovalimab-treated participants
Time Frame
Up to 6.5 years
Title
Observed Value in Reticulocyte Count (count/mL)
Time Frame
Up to 6.5 years
Title
Observed Value in Free Hemoglobin and Haptoglobin (mg/dL)
Time Frame
Up to 6.5 years
Title
Change in Reticulocyte Count (count/mL)
Time Frame
Baseline up to Week 25
Title
Change in Free Hemoglobin and Haptoglobin (mg/dL)
Time Frame
Baseline up to Week 25

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body weight >= 40 kg at screening. Willingness and ability to comply with all study visits and procedures. Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry. LDH level >= 2x ULN at screening (as per local assessment). Vaccination against Neisseria meningitidis serotypes A, C, W, < 3 years prior to initiation of study treatment; or, if not previously done, vaccination administered no later than one week after the first drug administration. Women of childbearing potential: agreement to remain abstinent or use contraception during the treatment period and for 10.5 months after the final dose of crovalimab or for 3 months after the final dose of eculizumab (or longer if required by the local product label). Exclusion Criteria: Current or previous treatment with a complement inhibitor. History of allogeneic bone marrow transplantation. History of Neisseria meningitidis infection within 6 months prior to screening and up to first study drug administration. History of myelodysplastic syndrome with Revised International Prognostic Scoring System (IPSS-R) prognostic risk categories of intermediate, high and very high. Pregnant or breastfeeding, or intending to become pregnant during the study, within 10.5 months after the final dose of crovalimab, or 3 months after the final dose of eculizumab (or longer if required by the local product label). Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever is greater. Concurrent disease, treatment, procedure or surgery, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the participant, or would, in the opinion of the Investigator, preclude the participant's safe participation in and completion of the study. Splenectomy < 6 months before screening. Positive for Active Hepatitis B and C infection (HBV/HCV). History of or ongoing cryoglobulinemia at screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Organizacion Medica de Investigacion (OMI)
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Centro Integrado de Oncologia de Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
80810-050
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre X
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
*X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
City
Santo André
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Beneficencia Portuguesa de Sao Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
01321-00
Country
Brazil
Facility Name
Peking Union Medical College Hospital
City
Beijing City
ZIP/Postal Code
100032
Country
China
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University
City
Hangzhou City
ZIP/Postal Code
310003
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
Affiliated Hospital of Nantong University; Nephrology
City
Nantong City
ZIP/Postal Code
226001
Country
China
Facility Name
Huashan Hospital, Fudan University
City
Shanghai City
ZIP/Postal Code
200040
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430022
Country
China
Facility Name
Hopital Claude Huriez - CHU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Universitaetsklinkm
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
General Hospital of Thessaloniki G. Papanikolaou
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
The Chinese University of Hong Kong; Department of Medicine & Therapeutics
City
Shatin
Country
Hong Kong
Facility Name
Sapporo Medical University Hospital
City
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
University of Tsukuba Hospital
City
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
NTT Medical Center Tokyo
City
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Vilnius University Hospital Santariskiu Clinics, Public Institution; Cardiology
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Hospital Tengku Ampuan Afzan
City
Kuantan
State/Province
Pahang
ZIP/Postal Code
25100
Country
Malaysia
Facility Name
Hospital Raja Permaisuri Bainun
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30990
Country
Malaysia
Facility Name
Hospital Ampang
City
Ampang
ZIP/Postal Code
68000
Country
Malaysia
Facility Name
Hospital Pulau Pinang
City
Penang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Global Trial Research Center S.A. de C.V.
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64718
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico
Country
Mexico
Facility Name
Amsterdam UMC, Locatie AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Mary Mediatrix Medical Center
City
Lipa City
ZIP/Postal Code
4217
Country
Philippines
Facility Name
Philippine General Hospital; Pulmonary Medicine
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
St Lukes Medical Center
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Szpital Uniwersytecki nr2 im. dr J. Biziela
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Centrum Medyczne Pratia Poznan
City
Skórzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
MTZ Clinical Research Powered by Pratia
City
Warszawa
ZIP/Postal Code
02-172
Country
Poland
Facility Name
Centro Hospitalar do Baixo Vouga E.P.E. - Hospital de Aveiro
City
Aveiro
ZIP/Postal Code
3814-501
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Central - Hospital D. Estefânia; Pediatrics
City
Lisboa
ZIP/Postal Code
1169-045
Country
Portugal
Facility Name
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
City
Lisbon
ZIP/Postal Code
1050-034
Country
Portugal
Facility Name
Centro Hospitalar do Porto - Hospital de Santo António
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Spitalul Universitar de Urgenta Bucuresti
City
Bucharest
ZIP/Postal Code
11172
Country
Romania
Facility Name
Spitalul Clinic Municipal Filantropia Craiova
City
Craiova
ZIP/Postal Code
200143
Country
Romania
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
117599
Country
Singapore
Facility Name
Singapore General Hospital; Department of Haematology
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
ICO Badalona - Hospital Universitari Germans Trias i Pujol; Hematologia Clinica
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario de Gran Canaria Doctor Negrín; Servicio de Hematología
City
Las Palmas de Gran Canaria
State/Province
LAS Palmas
ZIP/Postal Code
35010
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital San Pedro de Alcantara
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Chang Gung Medical Foundation - Kaohsiung; Oncology
City
Kaohisung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
National Taiwan Universtiy Hospital; Division of Hematology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Ondokuz Mayis Univ. Med. Fac.
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Medical Center OK!Clinic+
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Mykolayiv Regional Hospital
City
Mykolaiv
State/Province
KIEV Governorate
ZIP/Postal Code
54058
Country
Ukraine
Facility Name
St James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Kings College Hospital; Kings Clinical Research Facility
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

A Phase III Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors.

We'll reach out to this number within 24 hrs