Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04740905




Registration number
NCT04740905
Ethics application status
Date submitted
3/02/2021
Date registered
5/02/2021

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion
Scientific title
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion
Secondary ID [1] 0 0
2020-000440-63
Secondary ID [2] 0 0
GR41984
Universal Trial Number (UTN)
Trial acronym
BALATON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Edema 0 0
Branch Retinal Vein Occlusion 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Faricimab
Treatment: Drugs - Aflibercept
Treatment: Surgery - Sham Procedure

Experimental: Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) - In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).

Active comparator: Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2) - In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).


Treatment: Drugs: Faricimab
Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.

Treatment: Drugs: Aflibercept
Aflibercept 2 mg will be administered by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).

Treatment: Surgery: Sham Procedure
The sham is a procedure that mimics an intravitreal (IVT) injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24
Timepoint [1] 0 0
From Baseline through Week 24
Secondary outcome [1] 0 0
Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24
Timepoint [1] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [2] 0 0
Part 1: Percentage of Participants Gaining =15 Letters in BCVA From Baseline in the Study Eye at Week 24
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Part 1: Percentage of Participants Gaining =15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Timepoint [3] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [4] 0 0
Part 1: Percentage of Participants Gaining =10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Timepoint [4] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [5] 0 0
Part 1: Percentage of Participants Gaining =5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Timepoint [5] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [6] 0 0
Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Timepoint [6] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [7] 0 0
Part 1: Percentage of Participants Avoiding a Loss of =15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Timepoint [7] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [8] 0 0
Part 1: Percentage of Participants Avoiding a Loss of =10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Timepoint [8] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [9] 0 0
Part 1: Percentage of Participants Avoiding a Loss of =5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Timepoint [9] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [10] 0 0
Part 1: Percentage of Participants Achieving =84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Timepoint [10] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [11] 0 0
Part 1: Percentage of Participants Achieving =69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Timepoint [11] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [12] 0 0
Part 1: Percentage of Participants With =38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Timepoint [12] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [13] 0 0
Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24
Timepoint [13] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [14] 0 0
Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24
Timepoint [14] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [15] 0 0
Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Timepoint [15] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [16] 0 0
Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Timepoint [16] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [17] 0 0
Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Timepoint [17] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Secondary outcome [18] 0 0
Part 1: Change From Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24
Timepoint [18] 0 0
Baseline and Week 24
Secondary outcome [19] 0 0
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Timepoint [19] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [20] 0 0
Parts 1 and 2: Percentage of Participants Gaining =15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Timepoint [20] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [21] 0 0
Parts 1 and 2: Percentage of Participants Gaining =10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Timepoint [21] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [22] 0 0
Parts 1 and 2: Percentage of Participants Gaining =5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Timepoint [22] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [23] 0 0
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Timepoint [23] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [24] 0 0
Parts 1 and 2: Percentage of Participants Avoiding a Loss of =15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Timepoint [24] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [25] 0 0
Parts 1 and 2: Percentage of Participants Avoiding a Loss of =10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Timepoint [25] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [26] 0 0
Parts 1 and 2: Percentage of Participants Avoiding a Loss of =5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Timepoint [26] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [27] 0 0
Parts 1 and 2: Percentage of Participants Achieving =84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Timepoint [27] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [28] 0 0
Parts 1 and 2: Percentage of Participants Achieving =69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Timepoint [28] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [29] 0 0
Parts 1 and 2: Percentage of Participants With =38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Timepoint [29] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [30] 0 0
Parts 1 and 2: Change From Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72
Timepoint [30] 0 0
Baseline and Weeks 24, 48, and 72
Secondary outcome [31] 0 0
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Timepoint [31] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [32] 0 0
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Timepoint [32] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [33] 0 0
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Timepoint [33] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [34] 0 0
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Timepoint [34] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [35] 0 0
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Timepoint [35] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [36] 0 0
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Timepoint [36] 0 0
Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [37] 0 0
Part 2: Percentage of Participants Avoiding a Loss of =15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Timepoint [37] 0 0
Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [38] 0 0
Part 2: Percentage of Participants Avoiding a Loss of =10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Timepoint [38] 0 0
Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [39] 0 0
Part 2: Percentage of Participants Avoiding a Loss of =5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Timepoint [39] 0 0
Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [40] 0 0
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Timepoint [40] 0 0
Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Secondary outcome [41] 0 0
Part 2: Percentage of Participants on Different Treatment Intervals at Week 68
Timepoint [41] 0 0
Week 68
Secondary outcome [42] 0 0
Part 2: Number of Study Drug Injections Received in the Study Eye From Week 24 Through Week 72
Timepoint [42] 0 0
From Week 24 to Week 72
Secondary outcome [43] 0 0
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
Timepoint [43] 0 0
Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Secondary outcome [44] 0 0
Incidence of Ocular Adverse Events in the Fellow Eye
Timepoint [44] 0 0
Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Secondary outcome [45] 0 0
Incidence of Non-Ocular Adverse Events
Timepoint [45] 0 0
Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Secondary outcome [46] 0 0
Plasma Concentration of Faricimab Over Time
Timepoint [46] 0 0
Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72
Secondary outcome [47] 0 0
Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and Post-Baseline During the Study
Timepoint [47] 0 0
Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72

Eligibility
Key inclusion criteria
* Foveal center-involved macular edema due to branch retinal vein occlusion (BRVO), diagnosed no longer than 4 months prior to the screening visit
* Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent) on Day 1
* Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
* For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any major illness or major surgical procedure within 1 month before screening
* Uncontrolled blood pressure
* Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
* Pregnant or breastfeeding, or intending to become pregnant during the study

Ocular Exclusion Criteria for Study Eye:

* History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening
* Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to RVO in the study eye (e.g., ischemic maculopathy, Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense subfoveal hard exudates, or other non-retinal conditions)
* Macular laser (focal/grid) in the study eye at any time prior to Day 1
* Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1
* Any prior or current treatment for macular edema; macular neovascularization, including diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD); and vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection
* Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheatotomy
* Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)

Ocular Exclusion Criteria for Both Eyes:

* Prior IVT administration of faricimab in either eye
* History of idiopathic or autoimmune-associated uveitis in either eye
* Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/06/2023
Sample size
Target
Accrual to date
Final
553
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Strathfield Retina Clinic - Strathfield
Recruitment hospital [2] 0 0
Save Sight Institute - Sydney
Recruitment hospital [3] 0 0
Sydney Retina Clinic and Day Surgery - Sydney
Recruitment hospital [4] 0 0
Centre For Eye Research Australia - East Melbourne
Recruitment hospital [5] 0 0
Retina Specialists Victoria - Rowville
Recruitment hospital [6] 0 0
The Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2135 - Strathfield
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
3178 - Rowville
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
South Dakota
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
Argentina
State/province [23] 0 0
Caba
Country [24] 0 0
Argentina
State/province [24] 0 0
Capital Federal
Country [25] 0 0
Argentina
State/province [25] 0 0
Ciudad Autonoma Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Mendoza
Country [27] 0 0
Argentina
State/province [27] 0 0
Rosario
Country [28] 0 0
Argentina
State/province [28] 0 0
San Nicolás
Country [29] 0 0
Austria
State/province [29] 0 0
Graz
Country [30] 0 0
Brazil
State/province [30] 0 0
RS
Country [31] 0 0
Brazil
State/province [31] 0 0
SC
Country [32] 0 0
Brazil
State/province [32] 0 0
SP
Country [33] 0 0
China
State/province [33] 0 0
Beijing
Country [34] 0 0
China
State/province [34] 0 0
Changchun
Country [35] 0 0
China
State/province [35] 0 0
Chengdu
Country [36] 0 0
China
State/province [36] 0 0
Guangzhou City
Country [37] 0 0
China
State/province [37] 0 0
Harbin
Country [38] 0 0
China
State/province [38] 0 0
Nanjing City
Country [39] 0 0
China
State/province [39] 0 0
Shanghai
Country [40] 0 0
China
State/province [40] 0 0
Shenyang City
Country [41] 0 0
China
State/province [41] 0 0
Tianjin City
Country [42] 0 0
China
State/province [42] 0 0
Wenzhou City
Country [43] 0 0
China
State/province [43] 0 0
Wuhan
Country [44] 0 0
China
State/province [44] 0 0
Zhengzhou
Country [45] 0 0
Czechia
State/province [45] 0 0
Ostrava
Country [46] 0 0
Czechia
State/province [46] 0 0
Prague
Country [47] 0 0
Czechia
State/province [47] 0 0
Sokolov
Country [48] 0 0
France
State/province [48] 0 0
Creteil
Country [49] 0 0
France
State/province [49] 0 0
Paris
Country [50] 0 0
Germany
State/province [50] 0 0
Freiburg
Country [51] 0 0
Germany
State/province [51] 0 0
Göttingen
Country [52] 0 0
Germany
State/province [52] 0 0
Ludwigshafen
Country [53] 0 0
Hong Kong
State/province [53] 0 0
Hong Kong
Country [54] 0 0
Hong Kong
State/province [54] 0 0
Mongkok
Country [55] 0 0
Hungary
State/province [55] 0 0
Budapest
Country [56] 0 0
Hungary
State/province [56] 0 0
Debrecen
Country [57] 0 0
Hungary
State/province [57] 0 0
Pécs
Country [58] 0 0
Hungary
State/province [58] 0 0
Szeged
Country [59] 0 0
Israel
State/province [59] 0 0
Haifa
Country [60] 0 0
Israel
State/province [60] 0 0
Jerusalem
Country [61] 0 0
Israel
State/province [61] 0 0
Petach Tikva
Country [62] 0 0
Israel
State/province [62] 0 0
Rehovot
Country [63] 0 0
Israel
State/province [63] 0 0
Tel Aviv
Country [64] 0 0
Italy
State/province [64] 0 0
Lazio
Country [65] 0 0
Italy
State/province [65] 0 0
Lombardia
Country [66] 0 0
Italy
State/province [66] 0 0
Toscana
Country [67] 0 0
Japan
State/province [67] 0 0
Aichi
Country [68] 0 0
Japan
State/province [68] 0 0
Chiba
Country [69] 0 0
Japan
State/province [69] 0 0
Fukuoka
Country [70] 0 0
Japan
State/province [70] 0 0
Fukushima
Country [71] 0 0
Japan
State/province [71] 0 0
Hokkaido
Country [72] 0 0
Japan
State/province [72] 0 0
Hyogo
Country [73] 0 0
Japan
State/province [73] 0 0
Ibaraki
Country [74] 0 0
Japan
State/province [74] 0 0
Kyoto
Country [75] 0 0
Japan
State/province [75] 0 0
Tokushima
Country [76] 0 0
Japan
State/province [76] 0 0
Tokyo
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Busan
Country [78] 0 0
Korea, Republic of
State/province [78] 0 0
Daegu
Country [79] 0 0
Korea, Republic of
State/province [79] 0 0
Seongnam-si
Country [80] 0 0
Korea, Republic of
State/province [80] 0 0
Seoul
Country [81] 0 0
Poland
State/province [81] 0 0
Bydgoszcz
Country [82] 0 0
Poland
State/province [82] 0 0
Bytom
Country [83] 0 0
Poland
State/province [83] 0 0
Gda?sk
Country [84] 0 0
Poland
State/province [84] 0 0
Gliwice
Country [85] 0 0
Poland
State/province [85] 0 0
Katowice
Country [86] 0 0
Poland
State/province [86] 0 0
Kraków
Country [87] 0 0
Poland
State/province [87] 0 0
Piaseczno
Country [88] 0 0
Poland
State/province [88] 0 0
Rybnik
Country [89] 0 0
Poland
State/province [89] 0 0
Tarnowskie Góry
Country [90] 0 0
Poland
State/province [90] 0 0
Warszawa
Country [91] 0 0
Portugal
State/province [91] 0 0
Coimbra
Country [92] 0 0
Portugal
State/province [92] 0 0
Porto
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Baskortostan
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Tatarstan
Country [95] 0 0
Russian Federation
State/province [95] 0 0
Irkutsk
Country [96] 0 0
Singapore
State/province [96] 0 0
Singapore
Country [97] 0 0
Spain
State/province [97] 0 0
Navarra
Country [98] 0 0
Spain
State/province [98] 0 0
Valencia
Country [99] 0 0
Spain
State/province [99] 0 0
Barcelona
Country [100] 0 0
Spain
State/province [100] 0 0
Madrid
Country [101] 0 0
Spain
State/province [101] 0 0
Valladolid
Country [102] 0 0
Taiwan
State/province [102] 0 0
Changhua
Country [103] 0 0
Taiwan
State/province [103] 0 0
Taipei
Country [104] 0 0
Taiwan
State/province [104] 0 0
Taoyuan
Country [105] 0 0
Taiwan
State/province [105] 0 0
Zhongzheng Dist.
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Belfast
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Bristol
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Cardiff
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Gloucestershire
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Leeds
Country [111] 0 0
United Kingdom
State/province [111] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Chugai Pharmaceutical
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04740905