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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04133909




Registration number
NCT04133909
Ethics application status
Date submitted
18/10/2019
Date registered
21/10/2019

Titles & IDs
Public title
Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level
Scientific title
A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Mepolizumab 100 mg SC as add-on Treatment in Participants With COPD Experiencing Frequent Exacerbations and Characterized by Eosinophil Levels (Study 208657)
Secondary ID [1] 0 0
208657
Universal Trial Number (UTN)
Trial acronym
MATINEE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Other - Mepolizumab

Placebo comparator: Placebo - Participants will receive placebo subcutaneously once every 4 weeks over a treatment period of at least 52 weeks up to a maximum of 104 weeks.

Experimental: Mepolizumab - Participants will receive mepolizumab subcutaneously once every 4 weeks over a treatment period of at least 52 weeks up to a maximum of 104 weeks.


Treatment: Drugs: Placebo
Placebo is a 0.9% sodium chloride solution. It will be administered as a subcutaneous (SC) injection delivered once every 4 weeks using a pre-filled safety syringe.

Treatment: Other: Mepolizumab
Mepolizumab is a sterile liquid formulation. It will be administered as a SC injection (100 mg/mL) delivered once every 4 weeks using a pre-filled safety syringe.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized rate of moderate or severe exacerbations
Timepoint [1] 0 0
Up to Week 104
Secondary outcome [1] 0 0
Time to first moderate or severe exacerbation
Timepoint [1] 0 0
Up to Week 104
Secondary outcome [2] 0 0
Number of COPD assessment test (CAT) responders
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Number of St. George's Respiratory Questionnaire (SGRQ) total score responders
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Number of Evaluating Respiratory Symptoms in COPD (E-RS: COPD) responders
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Annualized rate of exacerbations requiring Emergency Department (ED) visit or hospitalization
Timepoint [5] 0 0
Up to Week 104

Eligibility
Key inclusion criteria
* Participant must be at least 40 years of age at Screening Visit 1.
* Participants with a peripheral blood eosinophil count of >=300 cells per microliter (µL) from the hematology sample collected at Screening Visit 0 AND a documented historical blood eosinophil count of >=150 cells per µL in the 12 months prior to Screening Visit 0 that meets the following: It must have been measured between 12 months and 1 month prior to Screening Visit 0, and it must not have been measured within 14 days of a COPD exacerbation. Participants with no documented historical blood eosinophil count of >=150 cells per µL must meet this threshold at the Screening Visit 1 assessment.
* Participants with a clinically documented history of COPD for at least 1 year in accordance with the definition by the American Thoracic Society or European Respiratory Society.
* Participants must present with a measured pre- and post-salbutamol Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio of <0.70 at Screening Visit 1 to confirm the diagnosis of COPD and with a measured post-salbutamol FEV1>20% and <=80% of predicted normal values calculated using NHANES III reference equations at Screening Visit 1.
* Participants must have a well-documented history (for example, medical record verification) in the 12 months prior to Screening Visit 1 of two or more moderate COPD exacerbations that were treated with systemic corticosteroids (intramuscular [IM], intravenous, or oral) with or without antibiotics or at least one severe COPD exacerbation requiring hospitalization.
* Participants must have a well-documented requirement for optimized standard of care background therapy that includes inhaled corticosteroids (ICS) plus 2 additional COPD medications (ICS-based triple therapy) for the 12 months prior to Screening Visit 1 and meets the following criteria: immediately prior to Screening Visit 1, minimum of 3 months of use of an 1) inhaled corticosteroid at a dose >=500 microgram (mcg) per day fluticasone propionate dose equivalent plus 2) Long acting beta2-agonist (LABA) and 3) Long acting muscarinic antagonist (LAMA) unless documentation of safety or intolerance issues related to LABA or LAMA. For participants who are not continually maintained on ICS plus LABA plus LAMA for the entire 12 months prior to Visit 1 use of the following is allowed (but not in the 3 months immediately prior to Visit 1); inhaled corticosteroid at a dose >=500 mcg per day fluticasone propionate dose equivalent plus inhaled LABA or inhaled LAMA and Phosphodiesterase-4-inhibitors, methylxanthines, or scheduled daily use of short acting beta2-agonist (SABA) and/or short acting muscarinic antagonist (SAMA).
* Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Screening (Visit 1) calculated as (number of pack years = [number of cigarettes per day/20] multiplied by number of years smoked [For example, 20 cigarettes per day for 10 years or 10 cigarettes per day for 20 years]).
* Contraceptive use for female participant should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: She is not a woman of childbearing potential (WOCBP) or she is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, during the intervention period and for at least 16 weeks after the last dose of study intervention. The principal investigator (PI) should evaluate the effectiveness of the contraceptive method in relation to the first dose of study intervention.
* A WOCBP must have a negative highly sensitive pregnancy urine test within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative (For example, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
* Participants capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Participants must meet following randomization inclusion criteria at Visit 2 to be randomized and commence the study intervention period: a) Participants that do not have documented historical blood eosinophil count of =150 cells/µL prior to Screening Visit must meet this threshold based on the Screening Visit 1 assessment, b) Participants must have eosinophil count of =300 cells/µL from the hematology sample collected at Screening Visit 0, c) Compliance with completion of the e-diary defined as completion of all questions on 5 or more days out of the 7 days immediately preceding Visit 2.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with a past history or concurrent diagnosis of asthma are excluded regardless of whether they have active or inactive disease.
* The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease. Participants with alpha1-antitrypsin deficiency as the underlying cause of COPD are excluded. Also, excluded are participants with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
* Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1.
* Participants with lung volume reduction surgery within the 12 months prior to Screening Visit 1.
* Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1. Participants who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
* Participants receiving treatment with oxygen more than 2 liter (L) per minute at rest over 24 hours. For participants receiving oxygen treatment, participants should demonstrate an oxyhemoglobin saturation greater than or equal to 89% while breathing supplemental oxygen.
* Participants with a QT interval, from the electrocardiogram (ECG) conducted at Screening Visit 1, corrected with Fridericia's formula (QTcF) >450 millisecond (msec) (or QTcF >480 msec in participants with bundle branch block). Fridericia's formula must be used to determine eligibility and discontinuation for an individual participant. Participants are excluded if an abnormal ECG finding from the 12-lead ECG conducted at Screening Visit 1 is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the Investigator.
* Participants with any of the following would be excluded: myocardial infarction or unstable angina in the 6 months prior to Screening Visit 1; unstable or life threatening cardiac arrhythmia requiring intervention in the 3 months prior to Screening Visit 1; New York Heart Association (NYHA) Class IV Heart failure.
* Participants with (historical or) current evidence of clinically significant, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
* Participants with other conditions that could lead to elevated eosinophils such as Hypereosinophilic syndromes including Eosinophilic Granulomatosis with Polyangiitis (EGPA), also known as Churg-Strauss Syndrome, or Eosinophilic Esophagitis.
* Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening Visit 1.
* A current malignancy or previous history of cancer in remission for less than 12 months prior to Screening Visit 1 (participants that had localized carcinoma of the skin or cervix which was resected for cure will not be excluded).
* Participants with a known immunodeficiency (For example, human immunodeficiency virus [HIV]), other than that explained by the use of corticosteroids taken for COPD.
* Participants with cirrhosis or current unstable liver disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice. Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C -e.g., presence of hepatitis B surface antigen [HbsAg] or positive hepatitis C antibody test result) is acceptable if the participant otherwise meets entry criteria.
* Participants who have received interventional product in previous mepolizumab studies are excluded.
* Participants who have received any monoclonal antibody within 5 half-lives of Screening Visit 1.
* Participants who have received an investigational drug within 30 days of Visit 1, or within 5 drug half-lives of the investigational drug, whichever is longer (this also includes investigational formulations of a marketed product).
* Participants who have received short term use of oral corticosteroids within 30 days of Visit 1.
* Participants with a known allergy or sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study or intolerance to another monoclonal antibody or biologic including history of anaphylaxis to another biologic.
* Participants at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
* Participants with conditions that will limit the validity of informed consent to participate in the study, for example, uncontrolled psychiatric disease or intellectual deficiency.
* Participants with a known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
* Participant is an Investigator, sub-Investigator, study coordinator, employee of a participating Investigator or study site, or immediate family member of the aforementioned that is involved in this study.
* Participants with a current active COVID-19 infection, either laboratory confirmed or according to the investigator's medical judgement and who are known to be in contact with active COVID-19 positive individuals within the past 14 days.
* Participant will not be randomized if they meet any of the following randomization exclusion criteria at Visit 2: a) Participants who have pneumonia, exacerbation, lower respiratory infection during the Run-in period. b) Evidence of clinically significant abnormality in the hematological or biochemical screen at Visit 1, as judged by the Investigator. c) Participants who meet the following based on results from sample taken at Screening Visit 1: Alanine aminotransferase (ALT) >2x upper limit of normal (ULN), bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%), cirrhosis or current unstable liver or biliary disease per Investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice. d) Participants who are pregnant or breastfeeding. Participants should not be randomized if they plan to become pregnant during the time of study participation. e) Participants that had an active COVID-19 infection during the Run-in period, either laboratory confirmed or according to the investigator's medical judgment or known to be in contact with active COVID-19 positive individuals within the past 14 days. f) Participants with a QT interval, from the ECG conducted at Visit 2, corrected with Fridericia's formula (QTcF) >450 msec (or QTcF >480 msec in participants with bundle branch block).

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

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/08/2024
Actual
Sample size
Target
Accrual to date
Final
806
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Coffs Harbour
Recruitment hospital [2] 0 0
GSK Investigational Site - New Lambton
Recruitment hospital [3] 0 0
GSK Investigational Site - Sydney
Recruitment hospital [4] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [5] 0 0
GSK Investigational Site - Kent Town
Recruitment hospital [6] 0 0
GSK Investigational Site - Woodville South
Recruitment hospital [7] 0 0
GSK Investigational Site - Frankston
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2305 - New Lambton
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
5067 - Kent Town
Recruitment postcode(s) [6] 0 0
5011 - Woodville South
Recruitment postcode(s) [7] 0 0
3199 - Frankston
Recruitment outside Australia
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Country [150] 0 0
Korea, Republic of
State/province [150] 0 0
Jeonju-si, Jeollabuk-do
Country [151] 0 0
Korea, Republic of
State/province [151] 0 0
Seoul
Country [152] 0 0
Mexico
State/province [152] 0 0
Jalisco
Country [153] 0 0
Mexico
State/province [153] 0 0
Nuevo León
Country [154] 0 0
Mexico
State/province [154] 0 0
Chihuahua
Country [155] 0 0
Mexico
State/province [155] 0 0
Mexico City
Country [156] 0 0
Netherlands
State/province [156] 0 0
Alkmaar
Country [157] 0 0
Netherlands
State/province [157] 0 0
Breda
Country [158] 0 0
Netherlands
State/province [158] 0 0
Den Haag
Country [159] 0 0
Netherlands
State/province [159] 0 0
Groningen
Country [160] 0 0
Netherlands
State/province [160] 0 0
Heerlen
Country [161] 0 0
Netherlands
State/province [161] 0 0
Rotterdam
Country [162] 0 0
Netherlands
State/province [162] 0 0
Zutphen
Country [163] 0 0
New Zealand
State/province [163] 0 0
Auckland
Country [164] 0 0
New Zealand
State/province [164] 0 0
Hamilton
Country [165] 0 0
New Zealand
State/province [165] 0 0
Havelock North
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New Zealand
State/province [166] 0 0
Rotorua
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New Zealand
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Wellington
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Poland
State/province [168] 0 0
Bialystok
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Poland
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Bydgoszcz
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Poland
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Czestochowa
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Poland
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Elblag
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Poland
State/province [172] 0 0
Gdansk
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Poland
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Gdynia
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Poland
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Poland
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Poland
State/province [176] 0 0
Krakow
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Poland
State/province [177] 0 0
Lodz
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Poland
State/province [178] 0 0
Lublin
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Poland
State/province [179] 0 0
Ostrow Wilekopolski
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Poland
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Poland
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Poland
State/province [182] 0 0
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Poland
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Sopot
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Poland
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Poland
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Poland
State/province [186] 0 0
Wroclaw
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Poland
State/province [187] 0 0
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Spain
State/province [188] 0 0
Andalucia
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Spain
State/province [189] 0 0
Castilla Y Leon
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Spain
State/province [190] 0 0
Alzira/Valencia
Country [191] 0 0
Spain
State/province [191] 0 0
Barcelona
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Spain
State/province [192] 0 0
Benalmadena Costa
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Spain
State/province [193] 0 0
Caceres
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Spain
State/province [194] 0 0
Cádiz
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Spain
State/province [195] 0 0
Galdakano
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Spain
State/province [196] 0 0
Granada
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Spain
State/province [197] 0 0
Guadalajara
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Spain
State/province [198] 0 0
L'Hospitalet de Llobregat
Country [199] 0 0
Spain
State/province [199] 0 0
Lleida
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Spain
State/province [200] 0 0
Logroño
Country [201] 0 0
Spain
State/province [201] 0 0
Loja/ Granada
Country [202] 0 0
Spain
State/province [202] 0 0
Pamplona
Country [203] 0 0
Spain
State/province [203] 0 0
Pozuelo De Alarcón/Madrid
Country [204] 0 0
Spain
State/province [204] 0 0
Sagunto/Valencia
Country [205] 0 0
Spain
State/province [205] 0 0
Santiago de Compostela
Country [206] 0 0
Spain
State/province [206] 0 0
Zaragoza
Country [207] 0 0
Sweden
State/province [207] 0 0
Härnösand
Country [208] 0 0
Sweden
State/province [208] 0 0
Malmö
Country [209] 0 0
Sweden
State/province [209] 0 0
Uppsala
Country [210] 0 0
Taiwan
State/province [210] 0 0
Taipei
Country [211] 0 0
United Kingdom
State/province [211] 0 0
Lanarkshire
Country [212] 0 0
United Kingdom
State/province [212] 0 0
Lancashire
Country [213] 0 0
United Kingdom
State/province [213] 0 0
Birmingham
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United Kingdom
State/province [214] 0 0
Cardiff
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United Kingdom
State/province [215] 0 0
Dundee
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Glasgow
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Gwaelod-y-Garth, Cardiff
Country [218] 0 0
United Kingdom
State/province [218] 0 0
Hexham
Country [219] 0 0
United Kingdom
State/province [219] 0 0
London
Country [220] 0 0
United Kingdom
State/province [220] 0 0
Manchester
Country [221] 0 0
United Kingdom
State/province [221] 0 0
Norwich
Country [222] 0 0
United Kingdom
State/province [222] 0 0
Stockton On Tees

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
PPD
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
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04133909