Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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/NCT03263091
Registration number
NCT03263091
Ethics application status
Date submitted
22/08/2017
Date registered
28/08/2017
Titles & IDs
Public title
Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden
Query!
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients With Lower Risk Myelodysplastic Syndrome (MDS) With Low Red Blood Cell (RBC) Transfusion Burden (LTB)
Query!
Secondary ID [1]
0
0
FGCL-4592-082
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts)
0
0
Query!
Anemia
0
0
Query!
Condition category
Condition code
Blood
0
0
0
0
Query!
Haematological diseases
Query!
Blood
0
0
0
0
Query!
Anaemia
Query!
Blood
0
0
0
0
Query!
Other blood disorders
Query!
Other
0
0
0
0
Query!
Research that is not of generic health relevance and not applicable to specific health categories listed above
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Roxadustat
Treatment: Drugs - Placebo
Experimental: Roxadustat - Open-label, lead-in: Participants will receive sequential escalating roxadustat doses (1.5 milligrams/kilograms \[mg/kg\], 2.0 mg/kg and 2.5 mg/kg), three times a week (TIW) based upon their actual weight at the randomization visit to identify the starting dose for double-blind period.
Double-blind: Participants will receive roxadustat 2.5 mg/kg TIW based upon their body weight for a duration of 52 weeks.
Open-label: Participants with high serum erythropoietin levels (\>400 milli-international units \[mIU\]/milliliter \[mL\] mIU/mL) will receive roxadustat 2.5 mg/kg TIW based upon their body weight for a duration of 52 weeks.
Placebo comparator: Placebo - Double-blind: Participants will receive placebo matching to roxadustat for a duration of 52 weeks.
Treatment: Drugs: Roxadustat
Oral tablets
Treatment: Drugs: Placebo
Oral tablets
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
OL and OL High-EPO Components: Number of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) =8 Weeks (=56 Consecutive Days) Since First Dose in the First 28 Weeks of Treatment
Query!
Assessment method [1]
0
0
The RBC TI was defined as the absence of any intravenous (IV) RBC transfusion (packed cell or whole blood) during any consecutive 56 days during the treatment period. Data presented is for number of participants with RBC TI =8 weeks (=56 consecutive days) since first dose in the first 28 weeks of treatment.
Query!
Timepoint [1]
0
0
28 weeks
Query!
Primary outcome [2]
0
0
DB Component: Number of Participants Who Achieved RBC TI =56 Consecutive Days Since First Dose in the First 28 Weeks of Treatment
Query!
Assessment method [2]
0
0
RBC TI was defined as the absence of any IV RBC transfusion (packed cell or whole blood) during any consecutive 56 days during the treatment period. Data presented is for number of participants with RBC TI =56 consecutive days since first dose in the first 28 weeks of treatment.
Query!
Timepoint [2]
0
0
28 weeks
Query!
Secondary outcome [1]
0
0
OL and OL High-EPO Components: Number of Participants Who Achieved TI =50% Reduction From Baseline in Number of Packs of Red Blood Cells (pRBC) Transfusions Over 8 Weeks
Query!
Assessment method [1]
0
0
Number of pRBC transfusions at baseline was defined as pRBC transfusions requirement during 8-week period prior to the start of first study medication. Responders were defined as participants with at least a 50% reduction in the number of pRBC transfusions over any 8-week (56 consecutive days) period during the study as compared with the baseline.
Query!
Timepoint [1]
0
0
Baseline up to Week 8
Query!
Secondary outcome [2]
0
0
DB Component: Number of Participants Who Achieved TI =56 Consecutive Days Since First Dose in 52 Weeks of Treatment
Query!
Assessment method [2]
0
0
RBC TI was defined as the absence of any IV RBC transfusion (packed cell or whole blood) during any consecutive 56 days during the treatment period. Data presented is for number of participants with RBC TI =56 consecutive days since first dose in the 52 weeks of treatment.
Query!
Timepoint [2]
0
0
52 weeks
Query!
Secondary outcome [3]
0
0
DB Component: Number of Participants Who Achieved TI =56 Consecutive Days Anytime During the Study
Query!
Assessment method [3]
0
0
RBC TI was defined as the absence of any IV RBC transfusion (packed cell or whole blood) during any consecutive 56 days anytime during the study (up to Week 56).
Query!
Timepoint [3]
0
0
Baseline up to Week 56
Query!
Secondary outcome [4]
0
0
DB Component: Number of Participants Who Achieved =50% Reduction From Baseline in Number of pRBC Transfusions Over 8 Weeks
Query!
Assessment method [4]
0
0
Baseline number of transfusions (pRBC/8-weeks) = total number of packs of rRBCs within 16 weeks prior to first dose/2. A pRBC transfusion reduction responder was defined as a participant who achieved =50% reduction in number of pRBC transfusions over 8 weeks compared to their baseline for any 8 week period in the duration begining with the first dose date (Day 1) and ending with the end of study or treatment discontinuation due to adverse event (AE)/serious adverse event (SAE) or death, whichever came earlier.
Query!
Timepoint [4]
0
0
Baseline up to Week 8
Query!
Secondary outcome [5]
0
0
DB Component: Cumulative Number of Participant Exposure Weeks (PEW) of TI Over the First 28 Weeks of Treatment
Query!
Assessment method [5]
0
0
The PEW of TI periods over the first 28 weeks was added up to a cumulative number of weeks. For a participant with at least 1 TI response period over the first 28 weeks, the last TI response period was ended with the date of a subsequent RBC transfusion, visit date at Week 28, date of the end of study or treatment discontinuation due to AE/SAE or death, whichever came earlier. For a participant with no TI response period over the first 28 weeks, the cumulative number of PEW was set to zero.
Query!
Timepoint [5]
0
0
28 weeks
Query!
Secondary outcome [6]
0
0
DB Component: Change From Baseline in Number of pRBC Packs Transfused Over the First 28 Weeks of Treatment
Query!
Assessment method [6]
0
0
Number of pRBC transfusions at baseline was defined as pRBC transfusions requirement during 8-week period prior to the start of first study medication.
Query!
Timepoint [6]
0
0
Baseline, Week 28
Query!
Secondary outcome [7]
0
0
DB Component: Number of Participants Who Achieved TI =20 Consecutive Weeks During the Study
Query!
Assessment method [7]
0
0
=20 consecutive weeks TI was defined as the absence of any IV RBC transfusion (packed cell or whole blood) during any consecutive 140 days anytime during the study (up to 56 weeks). TI was estimated between the first dose date (Day 1) and the end of study (Week 56) or treatment discontinuation due to AE/SAE or death, whichever came earlier.
Query!
Timepoint [7]
0
0
Baseline up to Week 56
Query!
Secondary outcome [8]
0
0
DB Component: Mean Change From Baseline in the Patient-Reported Outcomes Measurement Information System-Short Form (PROMIS-SF) v2.0 Physical Function (PF) 10b Score at Week 9
Query!
Assessment method [8]
0
0
The PROMIS physical function item measures self-reported, current capability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. The PF 10-item short form which contains 10 questions was used in this study, and each item was scored on a 5-point rating scale (1 \[unable to do\] to 5 \[without any difficulty\]), with higher scores indicating better functioning. Total raw score was the sum of the response to each question, with the lowest possible raw score 10 (poor physical function) and the highest possible raw score 50 (better physical function). Raw scores converted to T-scores (as detailed in the T-score conversion table for PROMIS-SF v2.0 Physical Function 10b) with a mean of 50 and a standard deviation (SD) of 10. T-scores ranged from minimum 13.8 to maximum 61.3 possible scores with higher scores indicating better physical functioning.
Query!
Timepoint [8]
0
0
Baseline, Week 9
Query!
Secondary outcome [9]
0
0
DB Component: Mean Change From Baseline in the PROMIS-SF v1.0 Fatigue 13a Score at Week 9
Query!
Assessment method [9]
0
0
Fatigue was measured using the 13-item fatigue scale of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System, each item was scored on a 5-point rating scale ranging from 1 "not at all" to 5 "very much", with lower scores indicating better functioning. Total raw score was the sum of the response to each question, with the lowest possible raw score 13 (lowest level of fatigue) and the highest possible raw score 65 (highest level of fatigue), with lower scores indicating better functioning. Raw scores converted to T-scores (as detailed in the T-score conversion table for PROMIS-SF v1.0 Fatigue 13a) with a mean of 50 and a SD of 10. T-scores ranged from minimum 30.3 to maximum 83.5 possible scores with lower scores indicating better functioning.
Query!
Timepoint [9]
0
0
Baseline, Week 9
Query!
Secondary outcome [10]
0
0
DB Component: Mean Change From Baseline in the European Quality of Life Five Dimensional Five Level Health Questionnaire (EQ-5D-5L) Visual Analogue Scale Score at Week 9
Query!
Assessment method [10]
0
0
The EQ-5D questionnaire is designed for self-completion by participants. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problem, moderate problems, severe problems, and unable to/extreme problems. The questionnaire also included a visual analogue scale, where the participant was asked to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state and 100 being the best imaginable health.
Query!
Timepoint [10]
0
0
Baseline, Week 9
Query!
Eligibility
Key inclusion criteria
Key
* Diagnosis of primary MDS classified by the International Prognostic Scoring System - Revised (IPSS-R) as very low, low or intermediate risk with <5% bone marrow blasts. There is no minimum time from diagnosis to registration/randomization except to allow for proper IPSS-R classification to be made (within 16 weeks prior to randomization), and to show transfusion dependence for participants in both portions of the study.
* RBC transfusion of either 2-4 pRBC units during the 8 weeks prior to registration/randomization or 1 pRBC in two consecutive periods of 8 weeks within the 16 weeks prior to registration/randomization. Open-Label Lead-in participants only, the requirement to demonstrate transfusion dependence can also be met by a Principal Investigator starting this particular participant on pRBC transfusion during the screening period.
* No restriction on prior use of recombinant erythropoietins or analogues (erythropoiesis-stimulating agents [ESAs]), except no ESA use within 8 weeks prior to Day 1 registration/randomization.
* Hemoglobin (Hb) =10.0 grams/deciliter (g/dL) during screening
* Eastern Cooperative Oncology Group (ECOG) of 0-2 at screening
Key
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Diagnosis of secondary MDS associated with prior chemotherapy, extensive radiation therapy (>25% of bone marrow reserve), and or/other significant chemical or radiation exposure
* Significant myelofibrosis (>2+ fibrosis)
* MDS associated with 5q(del) cytogenetic abnormality
* Screen serum erythropoietin level > 400 milli-international units (mIU)/milliliter (mL) • Clinically significant anemia, as determined by the investigator, due to non-MDS etiologies such as iron deficiency, vitamin B12 or folate deficiency, autoimmune or hereditary hemolysis or anemia or hemorrhage or hereditary anemia such as sickle cell anemia or thalassemia.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
29/01/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
20/06/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
184
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,Saint AlbansTAS
Query!
Recruitment hospital [1]
0
0
Investigational Site - Darlinghurst
Query!
Recruitment hospital [2]
0
0
Investigational Site - Liverpool
Query!
Recruitment hospital [3]
0
0
Investigational Site - South Brisbane
Query!
Recruitment hospital [4]
0
0
Investigational Site - Victoria Park
Query!
Recruitment hospital [5]
0
0
Investigational Site - Hobart
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [3]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [4]
0
0
3021 - Victoria Park
Query!
Recruitment postcode(s) [5]
0
0
7000 - Hobart
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Missouri
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
North Carolina
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Ohio
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Pennsylvania
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
South Carolina
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Texas
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Virginia
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Antwerpen
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Brussels Capital Region
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Limburg
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
West-Vlaanderen
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Brussels
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
Yvoir
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
British Columbia
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
Ontario
Query!
Country [20]
0
0
Denmark
Query!
State/province [20]
0
0
Odense
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Alpes-Maritimes
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Isère
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Paris
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Tours
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Baden-Wurttemberg
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Bayern
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Nordrhein-Westfalen
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Sachsen
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Düsseldorf
Query!
Country [30]
0
0
India
Query!
State/province [30]
0
0
Tamil Nadu
Query!
Country [31]
0
0
India
Query!
State/province [31]
0
0
West Bengal
Query!
Country [32]
0
0
Israel
Query!
State/province [32]
0
0
HaMerkaz
Query!
Country [33]
0
0
Israel
Query!
State/province [33]
0
0
HaZafon
Query!
Country [34]
0
0
Israel
Query!
State/province [34]
0
0
Haifa
Query!
Country [35]
0
0
Israel
Query!
State/province [35]
0
0
Ramat Gan
Query!
Country [36]
0
0
Israel
Query!
State/province [36]
0
0
Tel Aviv
Query!
Country [37]
0
0
Israel
Query!
State/province [37]
0
0
Tel HaShomer
Query!
Country [38]
0
0
Italy
Query!
State/province [38]
0
0
Lombardia
Query!
Country [39]
0
0
Italy
Query!
State/province [39]
0
0
Ravenna
Query!
Country [40]
0
0
Italy
Query!
State/province [40]
0
0
Alessandria
Query!
Country [41]
0
0
Italy
Query!
State/province [41]
0
0
Bologna
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
Firenze
Query!
Country [43]
0
0
Italy
Query!
State/province [43]
0
0
Genova
Query!
Country [44]
0
0
Italy
Query!
State/province [44]
0
0
Lecce
Query!
Country [45]
0
0
Italy
Query!
State/province [45]
0
0
Milano
Query!
Country [46]
0
0
Italy
Query!
State/province [46]
0
0
Reggio Calabria
Query!
Country [47]
0
0
Italy
Query!
State/province [47]
0
0
Rimini
Query!
Country [48]
0
0
Italy
Query!
State/province [48]
0
0
Roma
Query!
Country [49]
0
0
Italy
Query!
State/province [49]
0
0
Terni
Query!
Country [50]
0
0
Italy
Query!
State/province [50]
0
0
Torino
Query!
Country [51]
0
0
Italy
Query!
State/province [51]
0
0
Varese
Query!
Country [52]
0
0
Korea, Republic of
Query!
State/province [52]
0
0
Incheon Gwang'yeogsi
Query!
Country [53]
0
0
Korea, Republic of
Query!
State/province [53]
0
0
Incheon Gwangyeogsi
Query!
Country [54]
0
0
Korea, Republic of
Query!
State/province [54]
0
0
Jeonranamdo
Query!
Country [55]
0
0
Korea, Republic of
Query!
State/province [55]
0
0
Seoul Teugbyeolsi
Query!
Country [56]
0
0
Korea, Republic of
Query!
State/province [56]
0
0
Seoul
Query!
Country [57]
0
0
Poland
Query!
State/province [57]
0
0
Bialystok
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Bydgoszcz
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Krakow
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Pila
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Skorzewo
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Slupsk
Query!
Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Warszawa
Query!
Country [64]
0
0
Russian Federation
Query!
State/province [64]
0
0
Kaluga
Query!
Country [65]
0
0
Russian Federation
Query!
State/province [65]
0
0
Moscow
Query!
Country [66]
0
0
Russian Federation
Query!
State/province [66]
0
0
Omsk
Query!
Country [67]
0
0
Russian Federation
Query!
State/province [67]
0
0
Saint Petersburg
Query!
Country [68]
0
0
Russian Federation
Query!
State/province [68]
0
0
St. Petersburg
Query!
Country [69]
0
0
Spain
Query!
State/province [69]
0
0
Barcelona
Query!
Country [70]
0
0
Spain
Query!
State/province [70]
0
0
Catalunya
Query!
Country [71]
0
0
Spain
Query!
State/province [71]
0
0
Navarra
Query!
Country [72]
0
0
Spain
Query!
State/province [72]
0
0
Madrid
Query!
Country [73]
0
0
Spain
Query!
State/province [73]
0
0
Salamanca
Query!
Country [74]
0
0
Spain
Query!
State/province [74]
0
0
Sevilla
Query!
Country [75]
0
0
Spain
Query!
State/province [75]
0
0
Valencia
Query!
Country [76]
0
0
Turkey
Query!
State/province [76]
0
0
Ankara
Query!
Country [77]
0
0
Turkey
Query!
State/province [77]
0
0
Dikimevi
Query!
Country [78]
0
0
Turkey
Query!
State/province [78]
0
0
Izmir
Query!
Country [79]
0
0
Turkey
Query!
State/province [79]
0
0
Kayseri
Query!
Country [80]
0
0
Turkey
Query!
State/province [80]
0
0
Tekirdag
Query!
Country [81]
0
0
Turkey
Query!
State/province [81]
0
0
Yenisehir
Query!
Country [82]
0
0
United Kingdom
Query!
State/province [82]
0
0
Lincolnshire
Query!
Country [83]
0
0
United Kingdom
Query!
State/province [83]
0
0
Oxford
Query!
Country [84]
0
0
United Kingdom
Query!
State/province [84]
0
0
Harrow
Query!
Country [85]
0
0
United Kingdom
Query!
State/province [85]
0
0
London
Query!
Country [86]
0
0
United Kingdom
Query!
State/province [86]
0
0
Manchester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
FibroGen
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
AstraZeneca
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Commercial sector/industry
Query!
Name [2]
0
0
Astellas Pharma Inc
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in participants with lower risk MDS and low red blood cell transfusion burden.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03263091
Query!
Trial related presentations / publications
Henry DH, Glaspy J, Harrup R, Mittelman M, Zhou A, Carraway HE, Bradley C, Saha G, Modelska K, Bartels P, Leong R, Yu KP. Roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndrome: Open-label, dose-selection, lead-in stage of a phase 3 study. Am J Hematol. 2022 Feb 1;97(2):174-184. doi: 10.1002/ajh.26397. Epub 2021 Nov 9.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/91/NCT03263091/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/91/NCT03263091/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03263091