Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma
MEA115588 A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma
1 other identifier
interventional
580
16 countries
134
Brief Summary
This study will evaluate two dose regimens of mepolizumab \[75mg intravenous (i.v.) or 100mg subcutaneous (SC) every 4 weeks\] compared with placebo over a 32 week treatment period in subjects with severe refractory asthma with elevated blood eosinophils. Efficacy will be measured by a reduction in the frequency of asthma exacerbations. Additional efficacy assessments will include measurements of lung function, symptom scores, and quality of life. Safety will be assessed by clinical laboratory samples, ECGs, immunogenicity and adverse events. This study is intended to replicate the Phase IIb/III study MEA112997. Subjects in MEA115588, who meet all eligibility criteria at screening visit, will enter the run-in period. Those subjects that are not able/eligible to be randomised at the end of the 6 week run-in period will be deemed run-in failures. Subjects will remain on their current maintenance therapy throughout the run-in, double-blind treatment administration and follow-up periods. Subjects who meet the randomisation eligibility criteria will be randomised in a 1:1:1 ratio to receive one of the following treatments every 4 weeks for a total of 8 doses: Mepolizumab 75 miligram (mg) i.v. and placebo SC, or Mepolizumab 100 mg SC and placebo i.v. or Placebo i.v. and placebo SC. Subjects that receive all 8 doses of double-blind treatment, and meet the eligibility criteria for the Open-Label Extension (OLE) Study, will be offered the opportunity to participate in the OLE trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Oct 2012
134 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2012
CompletedFirst Posted
Study publicly available on registry
September 24, 2012
CompletedStudy Start
First participant enrolled
October 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2014
CompletedResults Posted
Study results publicly available
January 26, 2016
CompletedAugust 6, 2018
August 1, 2018
1.2 years
September 20, 2012
November 5, 2015
August 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Clinically Significant Exacerbations of Asthma Per Year
Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.
From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose
Secondary Outcomes (4)
Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visits Per Year
From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose
Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an ICU) Per Year
From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose
Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 32
Baseline, Week 32
Mean Change From Baseline in the St. George's Respiratory Questionnaire Total Score at Week 32
Baseline, Week 32
Study Arms (3)
Mepolizumab IV
EXPERIMENTALMepolizumab 75 mg will be administered intravenously approximately every 4 weeks with the last dose at week 32. Subjects in the Mepolizumab IV arm will receive mepolizumab 75 mg intravenously and placebo SC once every 4 weeks with the last dose at Week 28 (total of 8 doses)
Mepolizumab SC
EXPERIMENTALSubjects in the Mepolizumab SC arm will receive mepolizumab 100 mg SC and placebo IV once every 4 weeks with the last dose at Week 28 (total of 8 doses)
Placebo
PLACEBO COMPARATORSubjects in the Placebo arm will receive matching placebo SC and placebo IV once every 4 weeks with the last dose at Week 28 (total of 8 doses)
Interventions
Mepolizumab 75 mg IV will be administered every 4 weeks with the last dose at Week 28
Mepolizumab 100 mg SC will be administered every 4 weeks with the last dose at Week 28
Normal saline (placebo) will be administered IV every 4 weeks with the last dose at Week 28
Normal saline (placebo) will be administered SC every 4 weeks with the last dose at Week 28
Eligibility Criteria
You may qualify if:
- Able to give written informed consent prior to participation in the study
- At least 12 years of age at visit 1 and a minimum weight of 45 kilogram (kg)
- A well-documented requirement for regular treatment with high dose inhaled corticosteroid (ICS) in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids (OCS)
- Current treatment with an additional controller medication, besides ICS, for at least 3 months or a documented failure in the past 12 months of an additional controller medication for at least 3 successive months
- Prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma
- At Visit 1, a pre-bronchodilator FEV1 \<80% (for subjects \>= 18 years of age), a pre-bronchodilator FEV1 \<90% or FEV1:FVC ratio \<0.8 (for subjects 12-17 years of age).
- Previously confirmed history of two or more exacerbations requiring treatment with systemic CS
- Male or Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control)
- French subjects will be included only if either affiliated to or a beneficiary of a social security category.
You may not qualify if:
- Current smokers or former smokers with a smoking history of \>=10 pack years
- Presence of a known pre-existing, clinically important lung condition other than asthma
- A current malignancy or previous history of malignancy in less than 12 months
- Known, pre-existing, unstable liver disease cirrhosis and known biliary abnormalities
- Known, pre-existing severe or clinically significant cardiovascular disease
- known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment
- Subjects with any eosinophilic diseases
- QTc(F) ≥450msec or QTc(F) ≥480 msec
- A history of alcohol/substance abuse
- Subject with known immunodeficiency
- Subjects who have received omalizumab within 130 days of Visit 1 or any monoclonal antibody (other than Xolair) to treat inflammatory disease within 5 half-lives of Visit 1
- Subjects who have received treatment with an investigational drug within the past 30 days or five terminal phase half-lives of the drug whichever is longer
- Subjects with allergy/intolerance to a monoclonal antibody or biologic.
- Subjects who are pregnant or breastfeeding
- Subjects who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (134)
GSK Investigational Site
Birmingham, Alabama, 35294, United States
GSK Investigational Site
Newport Beach, California, 92663, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Rolling Hills Estates, California, 90274, United States
GSK Investigational Site
Denver, Colorado, 80206, United States
GSK Investigational Site
New Haven, Connecticut, 06520, United States
GSK Investigational Site
Albany, Georgia, 31707, United States
GSK Investigational Site
Chicago, Illinois, 60612, United States
GSK Investigational Site
Baltimore, Maryland, 21224, United States
GSK Investigational Site
Rochester, Minnesota, 55905, United States
GSK Investigational Site
New York, New York, 10029, United States
GSK Investigational Site
Rochester, New York, 14642, United States
GSK Investigational Site
Durham, North Carolina, 27705, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Cincinnati, Ohio, 45229, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Cleveland, Ohio, 44195, United States
GSK Investigational Site
Columbus, Ohio, 43221, United States
GSK Investigational Site
Hershey, Pennsylvania, 17033, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Salt Lake City, Utah, 84132-2409, United States
GSK Investigational Site
Mar del Plata, Buenos Aires, 7600, Argentina
GSK Investigational Site
Mar del Plata, Buenos Aires, B7600FZN, Argentina
GSK Investigational Site
San Rafael, Mendoza Province, 5600, Argentina
GSK Investigational Site
Rosario, Santa Fe Province, S2000DBS, Argentina
GSK Investigational Site
Buenos Aires, C1424BSF, Argentina
GSK Investigational Site
Buenos Aires, C1426ABP, Argentina
GSK Investigational Site
Mendoza, 5500, Argentina
GSK Investigational Site
New Lambton, New South Wales, 2305, Australia
GSK Investigational Site
Bedford Park, South Australia, 5042, Australia
GSK Investigational Site
Clayton, Victoria, 3168, Australia
GSK Investigational Site
Nedlands, Western Australia, 6009, Australia
GSK Investigational Site
Parkville, 3052, Australia
GSK Investigational Site
Brussels, 1020, Belgium
GSK Investigational Site
Ghent, 9000, Belgium
GSK Investigational Site
Leuven, 3000, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Calgary, Alberta, T2N 4Z6, Canada
GSK Investigational Site
Edmonton, Alberta, T6G2E1, Canada
GSK Investigational Site
Vancouver, British Columbia, V5Z 1M9, Canada
GSK Investigational Site
Winnipeg, Manitoba, R2H 2A6, Canada
GSK Investigational Site
Burlington, Ontario, L7N 3V2, Canada
GSK Investigational Site
Hamilton, Ontario, L8N 3Z5, Canada
GSK Investigational Site
Windsor, Ontario, N8X 5A6, Canada
GSK Investigational Site
Montreal, Quebec, H2W 1T8, Canada
GSK Investigational Site
Montreal, Quebec, H2X 2P4, Canada
GSK Investigational Site
Montreal, Quebec, H4J 1C5, Canada
GSK Investigational Site
Québec, Quebec, G1V 4G5, Canada
GSK Investigational Site
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1, Canada
GSK Investigational Site
Rancagua, Reg Del Libert Bern Ohiggins, 2841959, Chile
GSK Investigational Site
Santiago, 8380453, Chile
GSK Investigational Site
Talcahuano, 4270918, Chile
GSK Investigational Site
Le Kremlin-Bicêtre, 94275, France
GSK Investigational Site
Lille, 59037, France
GSK Investigational Site
Lyon, 69317, France
GSK Investigational Site
Marseille, 13915, France
GSK Investigational Site
Montpellier, 34295, France
GSK Investigational Site
Perpignan, 66000, France
GSK Investigational Site
Saint-Pierre, 97448, France
GSK Investigational Site
Aschaffenburg, Bavaria, 63739, Germany
GSK Investigational Site
Potsdam, Brandenburg, 14478, Germany
GSK Investigational Site
Rüdersdorf, Brandenburg, 15562, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60389, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60596, Germany
GSK Investigational Site
Gelnhausen, Hesse, 63571, Germany
GSK Investigational Site
Neu-Isenburg, Hesse, 63263, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39112, Germany
GSK Investigational Site
Berlin, 10367, Germany
GSK Investigational Site
Hamburg, 22299, Germany
GSK Investigational Site
Foggia, Apulia, 71100, Italy
GSK Investigational Site
Napoli, Campania, 80131, Italy
GSK Investigational Site
Parma, Emilia-Romagna, 43125, Italy
GSK Investigational Site
Genoa, Liguria, 16132, Italy
GSK Investigational Site
Pietra Ligure (SV), Liguria, 17027, Italy
GSK Investigational Site
Pisa, Tuscany, 56124, Italy
GSK Investigational Site
Perugia, Umbria, 06156, Italy
GSK Investigational Site
Cittadella PD, Veneto, 35013, Italy
GSK Investigational Site
Chiba, 296-8602, Japan
GSK Investigational Site
Fukuoka, 802-0052, Japan
GSK Investigational Site
Fukuoka, 811-1394, Japan
GSK Investigational Site
Fukuoka, 832-0059, Japan
GSK Investigational Site
Gunma, 370-0615, Japan
GSK Investigational Site
Hiroshima, 732-0052, Japan
GSK Investigational Site
Hokkaido, 062-8618, Japan
GSK Investigational Site
Hokkaido, 070-8644, Japan
GSK Investigational Site
Hyōgo, 651-0072, Japan
GSK Investigational Site
Hyōgo, 672-8064, Japan
GSK Investigational Site
Ibaraki, 319-1113, Japan
GSK Investigational Site
Kanagawa, 252-0392, Japan
GSK Investigational Site
Kumamoto, 861-1196, Japan
GSK Investigational Site
Mie, 515-8544, Japan
GSK Investigational Site
Okinawa, 901-2132, Japan
GSK Investigational Site
Okinawa, 904-2293, Japan
GSK Investigational Site
Osaka, 560-8552, Japan
GSK Investigational Site
Osaka, 596-8501, Japan
GSK Investigational Site
Tokyo, 102-0083, Japan
GSK Investigational Site
Tokyo, 103-0027, Japan
GSK Investigational Site
Tokyo, 171-0014, Japan
GSK Investigational Site
Tokyo, 187-0024, Japan
GSK Investigational Site
Zapopan, Jalisco, 45040, Mexico
GSK Investigational Site
Zapopan, Jalisco, 45200, Mexico
GSK Investigational Site
Monterrey, Nuevo León, 64020, Mexico
GSK Investigational Site
México DF, 14050, Mexico
GSK Investigational Site
Chelyabinsk, 454106, Russia
GSK Investigational Site
Moscow, 123182, Russia
GSK Investigational Site
Saint Petersburg, 194354, Russia
GSK Investigational Site
Saint Petersburg, 194356, Russia
GSK Investigational Site
Anyang-si, 431-070, South Korea
GSK Investigational Site
Bucheon-si, 420-767, South Korea
GSK Investigational Site
Cheongju, Chungcheongbuk-do, 361-711, South Korea
GSK Investigational Site
Daegu, 705-717, South Korea
GSK Investigational Site
Donggu Gwangju, 501757, South Korea
GSK Investigational Site
Incheon, 405-760, South Korea
GSK Investigational Site
Jeonju-si, Jeollabuk-Do, 561-712, South Korea
GSK Investigational Site
Kangwon-do, 220-701, South Korea
GSK Investigational Site
Seoul, 120-752, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Suwon, Kyonggi-do, 443-721, South Korea
GSK Investigational Site
Alicante, 03004, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Barcelona, 08041, Spain
GSK Investigational Site
Barcelona, 08208, Spain
GSK Investigational Site
Pozuelo de Alarcón/Madrid, 28223, Spain
GSK Investigational Site
Kharkiv, 61124, Ukraine
GSK Investigational Site
Kiev, 03680, Ukraine
GSK Investigational Site
Mykolayiv, 54003, Ukraine
GSK Investigational Site
Vinnytsia, 21018, Ukraine
GSK Investigational Site
Bradford, BD9 6RJ, United Kingdom
GSK Investigational Site
Glasgow, G11 6NT, United Kingdom
GSK Investigational Site
London, EC1M 6BQ, United Kingdom
GSK Investigational Site
Plymouth, PL6 8DH, United Kingdom
GSK Investigational Site
Southampton, SO16 6YD, United Kingdom
Related Publications (17)
Chen W, Reddel HK, FitzGerald JM, Beasley R, Janson C, Sadatsafavi M. Can we predict who will benefit most from biologics in severe asthma? A post-hoc analysis of two phase 3 trials. Respir Res. 2023 May 2;24(1):120. doi: 10.1186/s12931-023-02409-2.
PMID: 37131185DERIVEDLemiere C, Taille C, Lee JK, Smith SG, Mallett S, Albers FC, Bradford ES, Yancey SW, Liu MC. Impact of baseline clinical asthma characteristics on the response to mepolizumab: a post hoc meta-analysis of two Phase III trials. Respir Res. 2021 Jun 22;22(1):184. doi: 10.1186/s12931-021-01767-z.
PMID: 34158028DERIVEDGibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4.
PMID: 34098955DERIVEDBest N, Price RG, Pouliquen IJ, Keene ON. Assessing efficacy in important subgroups in confirmatory trials: An example using Bayesian dynamic borrowing. Pharm Stat. 2021 May;20(3):551-562. doi: 10.1002/pst.2093. Epub 2021 Jan 21.
PMID: 33475231DERIVEDWardlaw A, Howarth PH, Israel E, Taille C, Quirce S, Mallett S, Bates S, Albers FC, Kwon N. Fungal sensitization and its relationship to mepolizumab response in patients with severe eosinophilic asthma. Clin Exp Allergy. 2020 Jul;50(7):869-872. doi: 10.1111/cea.13680. Epub 2020 Jun 25. No abstract available.
PMID: 32515118DERIVEDKim MK, Park HS, Park CS, Min SJ, Albers FC, Yancey SW, Mayer B, Kwon N. Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies. Korean J Intern Med. 2021 Mar;36(2):362-370. doi: 10.3904/kjim.2019.198. Epub 2020 May 26.
PMID: 32450626DERIVEDKhurana S, Brusselle GG, Bel EH, FitzGerald JM, Masoli M, Korn S, Kato M, Albers FC, Bradford ES, Gilson MJ, Price RG, Humbert M. Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study. Clin Ther. 2019 Oct;41(10):2041-2056.e5. doi: 10.1016/j.clinthera.2019.07.007. Epub 2019 Aug 22.
PMID: 31447130DERIVEDKhurana S, Lyness JM, Mallett S, Nelsen LM, Prazma CM, Albers FC, Forshag M, Llanos JP, Yancey SW, Ortega HG. Association of depressive symptoms with health status and markers of uncontrolled severe asthma. Allergy Asthma Proc. 2019 Jul 1;40(4):230-239. doi: 10.2500/aap.2019.40.4229.
PMID: 31262378DERIVEDNelsen LM, Cockle SM, Gunsoy NB, Jones P, Albers FC, Bradford ES, Mullerova H. Impact of exacerbations on St George's Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study. J Asthma. 2020 Sep;57(9):1006-1016. doi: 10.1080/02770903.2019.1630640. Epub 2019 Jun 28.
PMID: 31251094DERIVEDYancey SW, Bradford ES, Keene ON. Disease burden and efficacy of mepolizumab in patients with severe asthma and blood eosinophil counts of >/=150-300 cells/muL. Respir Med. 2019 May;151:139-141. doi: 10.1016/j.rmed.2019.04.008. Epub 2019 Apr 8.
PMID: 31047111DERIVEDOrtega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5. No abstract available.
PMID: 30954640DERIVEDOrtega H, Menzies-Gow A, Llanos JP, Forshag M, Albers F, Gunsoy N, Bradford ES, Yancey SW, Kraft M. Rapid and Consistent Improvements in Morning PEF in Patients with Severe Eosinophilic Asthma Treated with Mepolizumab. Adv Ther. 2018 Jul;35(7):1059-1068. doi: 10.1007/s12325-018-0727-8. Epub 2018 Jun 15.
PMID: 29949045DERIVEDOrtega H, Yancey SW, Keene ON, Gunsoy NB, Albers FC, Howarth PH. Asthma Exacerbations Associated with Lung Function Decline in Patients with Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):980-986.e1. doi: 10.1016/j.jaip.2017.12.019. Epub 2018 Feb 15.
PMID: 29398640DERIVEDGunsoy NB, Cockle SM, Yancey SW, Keene ON, Bradford ES, Albers FC, Pavord ID. Evaluation of Potential Continuation Rules for Mepolizumab Treatment of Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):874-882.e4. doi: 10.1016/j.jaip.2017.11.026. Epub 2017 Dec 16.
PMID: 29258789DERIVEDAlbers FC, Price RG, Smith SG, Yancey SW. Mepolizumab efficacy in patients with severe eosinophilic asthma receiving different controller therapies. J Allergy Clin Immunol. 2017 Nov;140(5):1464-1466.e4. doi: 10.1016/j.jaci.2017.06.010. Epub 2017 Jul 4. No abstract available.
PMID: 28687231DERIVEDMagnan A, Bourdin A, Prazma CM, Albers FC, Price RG, Yancey SW, Ortega H. Treatment response with mepolizumab in severe eosinophilic asthma patients with previous omalizumab treatment. Allergy. 2016 Sep;71(9):1335-44. doi: 10.1111/all.12914. Epub 2016 May 24.
PMID: 27087007DERIVEDOrtega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, Humbert M, Katz LE, Keene ON, Yancey SW, Chanez P; MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1198-207. doi: 10.1056/NEJMoa1403290. Epub 2014 Sep 8.
PMID: 25199059DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2012
First Posted
September 24, 2012
Study Start
October 8, 2012
Primary Completion
January 1, 2014
Study Completion
January 18, 2014
Last Updated
August 6, 2018
Results First Posted
January 26, 2016
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.