Last updated: 07/17/2024 17:02:12
Anemia Studies in Chronic Kidney Disease: Erythropoiesis via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A phase 3 randomized, open-label (sponsor-blind), active-controlled, parallel-group, multi-center, event driven study in dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to recombinant human erythropoietin, following a switch from erythropoietin-stimulating agents
Trial description: The purpose of this multi-center event-driven study in participants with anemia associated with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Time to the first occurrence of adjudicated major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal myocardial infarction [MI] and non-fatal stroke)
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 3.3 years)
Mean change in hemoglobin (Hgb) between Baseline and efficacy period (EP) (mean over Weeks 28-52)
Timeframe: Baseline and up to and including Week 52
Secondary outcomes:
Time to first occurrence of adjudicated MACE
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 3.3 years)
Time to first occurrence of adjudicated MACE or a thromboembolic event (vascular access thrombosis, symptomatic deep vein thrombosis or symptomatic pulmonary embolism)
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 3.3 years)
Time to first occurrence of adjudicated MACE or a hospitalization for heart failure (HF)
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 3.3 years)
Average monthly intravenous (IV) iron dose milligram (mg) per subject to Week 52
Timeframe: Up to and including Week 52
Time to first occurrence of all-cause mortality, cardiovascular (CV) mortality, fatal or non-fatal MI, fatal or non-fatal stroke
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 3.3 years)
Time to first occurrence of MACE or hospitalization for HF (recurrent events analysis)
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 3.3 years)
Time to first occurrence of CV death or non fatal MI incidences
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 3.3 years)
Time to first occurrence of all-cause hospitalization
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 3.3 years)
Time to first occurrence of all cause hospital re-admission within 30 days
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 3.3 years)
Time to first occurrence of MACE or hospitalization for HF or thromboembolic events
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 3.3 years)
Time to first occurrence of Hospitalization for HF
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 3.3 years)
Time to first occurrence of Thromboembolic events
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 3.3 years)
Hgb change from Baseline to Week 52
Timeframe: Baseline, and up to and including Week 52
Percentage of responders, defined as mean Hgb within Hgb analysis range
Timeframe: Up to and including Week 52
Number of responders, defined as mean Hgb within Hgb analysis range
Timeframe: Up to and including Week 52
Percentage time for which Hgb is in analysis range during the EP (Week 28 to 52) and during the maintenance period (MP; Week 28 to end of trial)
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 3.3 years)
Change from Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) at Week 52 and at end of treatment
Timeframe: Baseline and up to 3.3 years
Number of blood pressure (BP) exacerbation events per 100 patient years
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 3.3 years)
Number of participants with least one BP exacerbation event during study
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 3.3 years)
Percentage of participants with least one BP exacerbation event during study
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 3.3 years)
Time to stopping randomized treatment due to meeting rescue criteria
Timeframe: Randomization (Day 1) to end of study (event-driven, up to 3.3 years)
Mean change in SF-36 Health Related Quality of Life (HRQOL) scores between Baseline and Weeks 8, 12, 28, 52, of particular interest are the changes from Baseline in the vitality and physical functioning domains at Weeks 28 and 52
Timeframe: Baseline, and up to and including Week 52
Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score at Week 52
Timeframe: Baseline, and up to and including Week 52
Change from Baseline in EQ-5D-5L visual analog scale (VAS) at Week 52
Timeframe: Baseline, and up to and including Week 52
Change from Baseline in Patient Global Impression of Severity Scale (PGI-S) at Week 8, 12, 28 and 52
Timeframe: Baseline, and up to and including Week 52
Interventions:
Drug: Daprodustat
Drug: rhEPO
Drug: Placebo
Drug: Iron therapy
Enrollment:
2964
Observational study model:
Not applicable
Primary completion date:
2020-09-11
Time perspective:
Not applicable
Clinical publications:
Ajay K. Singh, Kevin Carroll, Vlado Perkovic, Scott Solomon, Vivekanand Jha, Kirsten, L. Johansen, Renato D. Lopes, Iain C. Macdougall, Gregorio T. Obrador, Sushrut S. Waikar, Christoph Wanner, David C. Wheeler, Andrzej Wiecek, Allison Blackorby, Borut Cizman, Alexander R. Cobitz, Rich Davies, Jo Dole, Lata Kler, Amy M. Meadowcroft, Xinyi Zhu, John J. V. McMurray for the ASCEND-D study group. DAPRODUSTAT FOR THE TREATMENT OF ANEMIA IN PATIENTS UNDERGOING DIALYSIS. N Engl J Med. 2021;
DOI: 10.1056/NEJMoa2113379
PMID: 34739194
Medical condition
Anaemia, Aspergillosis, Allergic Bronchopulmonary
Product
GSK584430, SB598954, daprodustat, darbepoetin alfa
Collaborators
Not applicable
Study date(s)
September 2016 to November 2020
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 99 years
Accepts healthy volunteers
No
- Age: 18 to 99 years of age (inclusive).
- Erythropoietin-stimulating agents (ESAs): Use of any approved ESA for at least the 6 weeks prior to screening and between screening and randomization.
- Kidney transplant: Planned living-related or living-unrelated kidney transplant within 52 weeks after study start (Day 1).
- Ferritin: <=100 nanograms (ng)/milliliter (mL) (<=100 micrograms/liter [L]) at screening.
Inclusion and exclusion criteria
Inclusion criteria:
- Age: 18 to 99 years of age (inclusive).
- Erythropoietin-stimulating agents (ESAs): Use of any approved ESA for at least the 6 weeks prior to screening and between screening and randomization.
- Hgb concentration: On Week -8: Hgb 8 to 12 grams per deciliter (g/dL). On randomization (Day 1): Hgb 8 to 11 g/dL and receiving at least the minimum ESA dose. Hgb >11 g/dL to 11.5 g/dL and receiving greater than the minimum ESA dose.
- Dialysis: On dialysis >90 days prior to screening and continuing on the same mode of dialysis from screening (Week -8) through to randomization (Day 1).
- Frequency of Dialysis: Hemodialysis (HD) >=2 times/week and peritoneal dialysis (PD) >=5 times/week. Home hemodialysis >=2 times/week.
- Compliance with placebo [randomization (Day 1) only]: >=80% and <=120% compliance with placebo during run-in period.
- Informed consent (screening only): capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Exclusion criteria:
- Kidney transplant: Planned living-related or living-unrelated kidney transplant within 52 weeks after study start (Day 1).
- Ferritin: <=100 nanograms (ng)/milliliter (mL) (<=100 micrograms/liter [L]) at screening.
- Transferrin saturation (TSAT) (screening only): <=20%.
- Aplasias: History of bone marrow aplasia or pure red cell aplasia.
- Other causes of anemia: Untreated Pernicious anemia, thalassemia major, sickle cell disease or myelodysplastic syndrome.
- Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant GI bleeding <=4 weeks prior to screening through to randomization (Day 1).
- MI or acute coronary syndrome: <=4 weeks prior to screening through to randomization (Day 1).
- Stroke or transient ischemic attack: <=4 weeks prior to screening through to randomization (Day 1).
- Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.
- Current uncontrolled hypertension: Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of recombinant human erythropoietin (rhEPO).
- Bazett’s corrected QT interval (QTcB) (Day 1): QTcB >500 millisecond (msec), or QTcB >530 msec in subjects with bundle branch block. There is no QT Interval Corrected for Heart Rate (QTc) exclusion for subjects with a predominantly ventricular paced rhythm.
- Alanine transaminase (ALT): >2x upper limit of normal (ULN) at screening.
- Bilirubin: >1.5xULN at screening.
- Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
- Malignancy: History of malignancy within the 2 years prior to screening through to randomization (Day 1) or currently receiving treatment for cancer, or complex kidney cyst (example [e.g.] Bosniak Category II F, III or IV) > 3 centimeter (cm); with the exception of localized squamous cell or basal cell carcinoma of the skin that has been definitively treated >=4 weeks prior to screening.
- Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product, or epoetin alfa or darbepoetin alfa.
- Drugs and supplements: Use of strong inhibitors of Cytochrome P4502C8 (CYP2C8) (e.g., gemfibrozil) or strong inducers of CYP2C8 (e.g., rifampin/rifampicin).
- Other study participation: Use of other investigational agent or device prior to screening through to randomization (Day 1).
- Prior treatment with daprodustat: Any prior treatment with daprodustat for treatment duration of >30 days.
- Females only: Subject is pregnant [as confirmed by a positive serum human chorionic gonadotrophin (hCG) test for females of reproductive potential (FRP) only], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow one of the contraceptive options listed in the List of Highly Effective Methods for Avoiding Pregnancy.
- Other Conditions: Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g., intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.
Trial location(s)
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Study Complete
Location
GSK Investigational Site
Aguascalientes, Aguascalientes, Mexico, 20230
Status
Study Complete
Location
GSK Investigational Site
Alexandria, Virginia, United States, 22304
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92801
Status
Study Complete
Location
GSK Investigational Site
Anderson, South Carolina, United States, 29621
Status
Study Complete
Location
GSK Investigational Site
Anyang-Si, Gyeonggi-do, South Korea, 14068
Status
Study Complete
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28801
Status
Study Complete
Location
GSK Investigational Site
Augusta, Georgia, United States, 30904
Status
Study Complete
Location
GSK Investigational Site
Augusta, Georgia, United States, 30912
Status
Study Complete
Location
GSK Investigational Site
Aventura, Florida, United States, 33180
Status
Study Complete
Location
GSK Investigational Site
Bakersfield, California, United States, 93309
Status
Study Complete
Location
GSK Investigational Site
Bakersfield, California, United States, 93308
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70836
Status
Study Complete
Location
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Status
Study Complete
Location
GSK Investigational Site
Bethlehem, Pennsylvania, United States, 18017
Status
Study Complete
Location
GSK Investigational Site
Beverly Hills, California, United States, 90211
Status
Study Complete
Location
GSK Investigational Site
Bluefield, West Virginia, United States, 24701
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, New York, United States, 11203
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1425
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1181ACH
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14215
Status
Study Complete
Location
GSK Investigational Site
Burzaco, Buenos Aires, Argentina, B1852FZD
Status
Study Complete
Location
GSK Investigational Site
Cerritos, California, United States, 90703
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29425
Status
Study Complete
Location
GSK Investigational Site
Chula Vista, California, United States, 91910
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45206
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45220
Status
Study Complete
Location
GSK Investigational Site
Ciudad De México, Estado de México, Mexico, 14000
Status
Study Complete
Location
GSK Investigational Site
Ciudad Evita, Buenos Aires, Argentina, B1778IFA
Status
Study Complete
Location
GSK Investigational Site
Cloppenburg, Niedersachsen, Germany, 49661
Status
Study Complete
Location
GSK Investigational Site
Clyde, North Carolina, United States, 28721
Status
Study Complete
Location
GSK Investigational Site
Columbus, Georgia, United States, 31904
Status
Study Complete
Location
GSK Investigational Site
Concord, New South Wales, Australia, 2139
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Cordova, Tennessee, United States, 38018
Status
Study Complete
Location
GSK Investigational Site
Crystal Lake, Illinois, United States, 60014
Status
Study Complete
Location
GSK Investigational Site
Cuautitlan Izcalli, Estado de México, Mexico, 54769
Status
Study Complete
Location
GSK Investigational Site
Curitiba, Paraná, Brazil, CEP 80230-130
Status
Study Complete
Location
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40210
Status
Study Complete
Location
GSK Investigational Site
El Centro, California, United States, 92243
Status
Study Complete
Location
GSK Investigational Site
Escondido, California, United States, 92025
Status
Study Complete
Location
GSK Investigational Site
Fairfax, Virginia, United States, 22033
Status
Study Complete
Location
GSK Investigational Site
Fairfield, California, United States, 94534
Status
Study Complete
Location
GSK Investigational Site
Florissant, Missouri, United States, 63033
Status
Study Complete
Location
GSK Investigational Site
Flushing, New York, United States, 11355
Status
Study Complete
Location
GSK Investigational Site
Fort Wayne, Indiana, United States, 46804
Status
Study Complete
Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Study Complete
Location
GSK Investigational Site
Gallup, New Mexico, United States, 87301
Status
Study Complete
Location
GSK Investigational Site
Glendale, California, United States, 91205
Status
Study Complete
Location
GSK Investigational Site
Goyang-si, Gyeonggi-do, South Korea, 411706
Status
Study Complete
Location
GSK Investigational Site
Granada Hills, California, United States, 91344
Status
Study Complete
Location
GSK Investigational Site
Gulfport, Mississippi, United States, 39501
Status
Study Complete
Location
GSK Investigational Site
Hacienda Heights, California, United States, 91745
Status
Study Complete
Location
GSK Investigational Site
Hampton, Virginia, United States, 23666
Status
Study Complete
Location
GSK Investigational Site
Hollywood, Florida, United States, 33024
Status
Study Complete
Location
GSK Investigational Site
Huntsville, Alabama, United States, 35805
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32224
Status
Study Complete
Location
GSK Investigational Site
Jeffersonville, Indiana, United States, 47130
Status
Study Complete
Location
GSK Investigational Site
Joinville, Santa Catarina, Brazil, 89227-680
Status
Study Complete
Location
GSK Investigational Site
Kaiserslautern, Rheinland-Pfalz, Germany, 67655
Status
Study Complete
Location
GSK Investigational Site
Kalmazoo, Michigan, United States, 49007
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64111
Status
Study Complete
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
Status
Study Complete
Location
GSK Investigational Site
Kingswood, New South Wales, Australia, 2750
Status
Study Complete
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37923
Status
Study Complete
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37924
Status
Study Complete
Location
GSK Investigational Site
Kogarah, New South Wales, Australia, 2217
Status
Study Complete
Location
GSK Investigational Site
La Mesa, California, United States, 91942
Status
Study Complete
Location
GSK Investigational Site
La Palma, California, United States, 90623
Status
Study Complete
Location
GSK Investigational Site
Lakewood, California, United States, 90712
Status
Study Complete
Location
GSK Investigational Site
Greenbelt, Maryland, United States, 20770
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89102
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89107
Status
Study Complete
Location
GSK Investigational Site
Lauderdale Lakes, Florida, United States, 33313
Status
Study Complete
Location
GSK Investigational Site
Liverpool, New South Wales, Australia, 2170
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90807
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90022
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90095
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40202
Status
Study Complete
Location
GSK Investigational Site
Lynwood, California, United States, 60262
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
Status
Study Complete
Location
GSK Investigational Site
Marianske Lazne, Czech Republic, 353 01
Status
Study Complete
Location
GSK Investigational Site
Merrillville, Indiana, United States, 46410
Status
Study Complete
Location
GSK Investigational Site
Miami Gardens, Florida, United States, 33169
Status
Study Complete
Location
GSK Investigational Site
Michigan City, Indiana, United States, 46360
Status
Study Complete
Location
GSK Investigational Site
Middlebury, Connecticut, United States, 06762
Status
Study Complete
Location
GSK Investigational Site
Mineola, New York, United States, 11501
Status
Study Complete
Location
GSK Investigational Site
Montebello, California, United States, 90640
Status
Study Complete
Location
GSK Investigational Site
Monterey Park, California, United States, 91754
Status
Study Complete
Location
GSK Investigational Site
Moreno Valley, California, United States, 92553
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37205
Status
Study Complete
Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10029
Status
Study Complete
Location
GSK Investigational Site
Norco, California, United States, 92860
Status
Study Complete
Location
GSK Investigational Site
Northridge, California, United States, 91324
Status
Study Complete
Location
GSK Investigational Site
Ontario, California, United States, 91762
Status
Study Complete
Location
GSK Investigational Site
Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
Status
Study Complete
Location
GSK Investigational Site
Pergamino, Buenos Aires, Argentina, B2700CPM
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Status
Study Complete
Location
GSK Investigational Site
Piacenza, Emilia-Romagna, Italy, 29100
Status
Study Complete
Location
GSK Investigational Site
Pine Bluff, Arkansas, United States, 71603
Status
Study Complete
Location
GSK Investigational Site
Port Charlotte, Florida, United States, 33952
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Status
Study Complete
Location
GSK Investigational Site
Portsmouth, New Hampshire, United States, 3801
Status
Study Complete
Location
GSK Investigational Site
Preston, Lancashire, United Kingdom, PR2 9HT
Status
Study Complete
Location
GSK Investigational Site
Providence, Rhode Island, United States, 02903
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Reggio Calabria, Calabria, Italy, 89124
Status
Study Complete
Location
GSK Investigational Site
Ridgewood, New York, United States, 11385
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92501
Status
Study Complete
Location
GSK Investigational Site
Pontiac, Michigan, United States, 48341
Status
Study Complete
Location
GSK Investigational Site
Roseburg, Oregon, United States, 97471
Status
Study Complete
Location
GSK Investigational Site
Roseville, Michigan, United States, 48066
Status
Study Complete
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18059
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95825
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78207
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78221
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78258
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78251
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92103
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92111
Status
Study Complete
Location
GSK Investigational Site
San Luis Obispo, California, United States, 93405
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucumán, Argentina, T4000AHL
Status
Study Complete
Location
GSK Investigational Site
Santa Clarita, California, United States, 91387
Status
Study Complete
Location
GSK Investigational Site
Sao Jose do Rio Preto, São Paulo, Brazil, 15090-000
Status
Study Complete
Location
GSK Investigational Site
Shorewood, Wisconsin, United States, 53211
Status
Study Complete
Location
GSK Investigational Site
Simi Valley, California, United States, 93065-091
Status
Study Complete
Location
GSK Investigational Site
Spring Hill, Florida, United States, 34608
Status
Study Complete
Location
GSK Investigational Site
St Leonards, New South Wales, Australia, 2065
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Study Complete
Location
GSK Investigational Site
Stevenage, Hertfordshire, United Kingdom, SG1 4AB
Status
Study Complete
Location
GSK Investigational Site
Sumter, South Carolina, United States, 29150
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 01323903
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 04039-000
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, ?04005-000
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, ?08270-070
Status
Study Complete
Location
GSK Investigational Site
Takoma Park, Maryland, United States, 20912-6385
Status
Study Complete
Location
GSK Investigational Site
Tarzana, California, United States, 91356
Status
Study Complete
Location
GSK Investigational Site
Tupelo, Mississippi, United States, 38801
Status
Study Complete
Location
GSK Investigational Site
Vila Franca de Xira, Portugal, 2600-076
Status
Study Complete
Location
GSK Investigational Site
Vila Real (Lordelo), Portugal, 5000-668
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20037
Status
Study Complete
Location
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Status
Study Complete
Location
GSK Investigational Site
Whittier, California, United States, 90602
Status
Study Complete
Location
GSK Investigational Site
Whittier, California, United States, 90603
Status
Study Complete
Location
GSK Investigational Site
Winston Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27517
Status
Study Complete
Location
GSK Investigational Site
Winter Park, Florida, United States, 32789
Status
Study Complete
Location
GSK Investigational Site
Wollongong, New South Wales, Australia, 2500
Status
Study Complete
Location
GSK Investigational Site
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Status
Study Complete
Location
GSK Investigational Site
Woolloongabba, Queensland, Australia, 4102
Status
Study Complete
Location
GSK Investigational Site
Yonkers, New York, United States, 10710
Status
Study Complete
Location
GSK Investigational Site
Yorba Linda, California, United States, 92886
Status
Study Complete
Location
GSK Investigational Site
Zhongzheng Dist., Taipei, Taiwan, 10002
Status
Study Complete
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2020-09-11
Actual study completion date
2020-09-11
Plain language summaries
Summary of results in plain language
Available language(s): English, Afrikaans, German (Austria), Bulgarian, Catalan, Czech, Danish, Dutch (Belgium), Dutch, Estonian, French (Belgium), French (Canadian), French, German, Greek, Gujarati, Hindi, Hungarian, Italian, Kannada, Korean, Malay (Malaysia), Malayalam, Marathi, Norwegian, Polish, Portuguese (Brazil), Portuguese (Native), Romanian, Russian, Samoan, Chinese (Simplified), Spanish (Argentina), Spanish (Mexico), Spanish, Spanish (United States), Swedish, Tamil (India), Tamil (Malaysia), Tamil (Singapore), Telugu, Chinese (Taiwan), Turkish, Ukrainian, Urdu, Xhosa, Tongan (New Zealand)
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