Last updated: 07/17/2024 16:55:34
Efficacy and Safety of Mepolizumab as an Add-on Treatment in Chronic Obstructive Pulmonary Disease (COPD)
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study MEA117113: Mepolizumab vs. Placebo as Add-on Treatment for Frequently Exacerbating COPD Patients Characterized by Eosinophil Level
Trial description: This is a multi-centered, randomized, placebo-controlled, double-blind, parallel group, trial evaluating 2 doses of mepolizumab against placebo given every 4 weeks through subcutaneous (SC) injection. In severe COPD subjects, sputum eosinophils levels are elevated to similar levels as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD subjects would translate into a reduction of COPD exacerbations. The study will evaluate the efficacy and safety of mepolizumab, in subjects who are at or above the baseline blood eosinophil count of at least 150 cells/microliters who exacerbate despite regular use of maximal tolerated therapy, appropriate for severe COPD subjects, in the 12 months prior to study start. In total, 660 subjects will be randomized in 1:1:1 ratio to receive mepolizumab 300 mg, mepolizumab 100mg, or placebo administered SC. The total duration of subject participation will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Rate of moderate or severe exacerbations
Timeframe: From randomization to Week 52
Secondary outcomes:
Time to first moderate/severe exacerbation
Timeframe: From randomization to Week 52
Rate of COPD exacerbations requiring emergency department (ED) visits and/or hospitalizations (hosp)
Timeframe: From randomization to Week 52
Change from Baseline in mean total St. George’s Respiratory Questionnaire (SGRQ) score
Timeframe: Baseline and Week 52
Change from Baseline in Mean COPD assessment test (CAT) score
Timeframe: Baseline and Week 52
Interventions:
Drug: Mepolizumab
Drug: Placebo
Enrollment:
674
Observational study model:
Not applicable
Primary completion date:
2017-16-01
Time perspective:
Not applicable
Clinical publications:
Pavord I, Chanez P, Criner G, Kerstjens H, Korn S, Lugogo N, Martinot J-B, Sagara H, Albers F, Bradford E, Harris S, Mayer B, Rubin D, Yancey S, Sciurba F. Mepolizumab for eosinophilic chronic obstructive pulmonary disease . N Engl J Med. 2017;377(17):1613-29.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
April 2014 to January 2017
Type
Interventional
Phase
2/3
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- COPD diagnosis: Subjects with a clinically documented history of COPD for at least 1 year in accordance with the following definition by the American Thoracic Society/European Respiratory Society
- Severity of COPD: Subjects must present with the following: a measured pre and post-salbutamol Forced expiratory volume in one second/ Forced vital capacity (FEV1/FVC) ratio of <0.70 at Visit 1 to confirm the diagnosis of COPD; a measured post-salbutamol FEV1> 20 percent and <=80 percent of predicted normal values calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations at Visit 1
- Subjects with Asthma: Current and Former Smokers: Subjects with a current diagnosis of asthma (those with a prior history are eligible if they meet inclusion criteria for a current diagnosis of COPD); Never-Smokers: Subjects with any history of asthma.
- Other respiratory disorders: The investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease. Subjects with alpha1-antitrypsin deficiency as the underlying cause of COPD are excluded. Also, excluded are subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases. Subjects are also excluded if maintenance use of bi-level positive airway pressure is required for the treatment of respiratory disorder.
Inclusion and exclusion criteria
Inclusion criteria:
- COPD diagnosis: Subjects with a clinically documented history of COPD for at least 1 year in accordance with the following definition by the American Thoracic Society/European Respiratory Society
- Severity of COPD: Subjects must present with the following: a measured pre and post-salbutamol Forced expiratory volume in one second/ Forced vital capacity (FEV1/FVC) ratio of <0.70 at Visit 1 to confirm the diagnosis of COPD; a measured post-salbutamol FEV1> 20 percent and <=80 percent of predicted normal values calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations at Visit 1
- History of exacerbations: A well documented history (e.g., medical record verification) in the 12 months prior to Visit 1 of ; at least two moderate COPD exacerbations. Moderate is defined as the use of systemic corticosteroids (intramuscular (IM), intravenous, or oral) and/or treatment with antibiotics or; at least one severe COPD exacerbation. Severe is defined as having required hospitalization. Note: At least one exacerbation must have occurred while the subject was taking Inhaled corticosteroid (ICS) plus long acting beta2-agonist (LABA) plus long acting muscarinic antagonist (LAMA). Prior use of antibiotics alone does not qualify as a moderate exacerbation unless the use was specifically for the treatment of worsening symptoms of COPD.
- Concomitant COPD therapy: A well documented requirement for optimized standard of care background therapy that includes Inhaled corticosteroid (ICS) plus 2 additional COPD medications (i.e., triple therapy) for the 12 months prior to Visit 1 and meets the following criteria: Immediately prior to Visit 1, minimum of 3 months of use of an; Inhaled corticosteroid at a dose >= 500 micrograms (mcg)/day fluticasone propionate dose equivalent plus; LABA and LAMA. For subjects who are not continually maintained on ICS plus LABA plus LAMA for the entire 12 months prior to Visit 1 use of following is allowed (but not in the 3 months immediately prior to Visit 1); inhaled corticosteroid at a dose >=500 mcg/day fluticasone propionate dose equivalent plus; a LABA or a LAMA and; use of at least one other class of COPD medication (i.e., phosphodiesterase-4-inhibitors, methylxanthines, or a combination of short acting beta2-agonist and short acting muscarinic antagonist).
- Informed Consent: Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials.
- Gender: Male or Eligible Female; To be eligible for entry into the study females of child bearing potential must commit to consistent and correct use of an acceptable method of birth control from the time of consent, for the duration of the trial, and for 4 months after last study drug administration.
- Age: At least 40 years of age at Visit 1
- Smoking status: Subject with confirmed COPD are eligible to participate independent of their smoking status and smoking history, i.e. current smokers, never smokers or ex-smokers can be enrolled into the study. Current smokers are defined as those with a history of cigarette smoking of >=10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Former smokers are defined as those who meet the definition of a current smoker but have stopped smoking for at least 6 months prior to Visit 1. Never smokers are those that do not meet the definition of a current or former smoker.
- French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Exclusion criteria:
- Subjects with Asthma: Current and Former Smokers: Subjects with a current diagnosis of asthma (those with a prior history are eligible if they meet inclusion criteria for a current diagnosis of COPD); Never-Smokers: Subjects with any history of asthma.
- Other respiratory disorders: The investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease. Subjects with alpha1-antitrypsin deficiency as the underlying cause of COPD are excluded. Also, excluded are subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases. Subjects are also excluded if maintenance use of bi-level positive airway pressure is required for the treatment of respiratory disorder.
- COPD stability: Subjects with pneumonia, exacerbation, lower respiratory infection within the 4 weeks prior to Visit 1.
- Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Visit 1.
- Pulmonary rehabilitation program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
- Oxygen: Subjects receiving treatment with oxygen more than 4.0 liters/minute (L/min). While breathing supplemental oxygen, subjects should demonstrate an oxyhemoglobin saturation greater than or equal to 89 percent.
- 12-lead Electrocardiography (ECG) finding: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1, if considered to be clinically significant by the Investigator. 12-lead ECGs will be over-read by a centralized independent cardiologist to assist in consistent evaluation of subject eligibility. Results from the 12-lead ECG over-read must be received prior to assessing eligibility at Visit 2.
- Unstable or life threatening cardiac disease: Subjects with any of the following would be excluded: Myocardial infarction or unstable angina in the last 6 months ; Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months ; New York Heart Association (NYHA) Class IV Heart failure
- Other diseases/abnormalities: Subjects with (historical or) current evidence of clinically significant, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
- Eosinophilic disease: Subjects 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.
- Parasitic infection: Subjects with a pre-existing helminthes infestation within 6 months prior to Visit 1 are also excluded.
- Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to Visit 1 (Subjects that had localized carcinoma of the skin or cervix which was resected for cure will not be excluded). South Korea subjects with a diagnosis of malignancy within 5 years of Visit 1 are excluded.
- Immunodeficiency: A known immunodeficiency (e.g. human immunodeficiency virus HIV), other than that explained by the use of corticosteroids taken for COPD.
- Liver disease: Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, and known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones). Chronic stable hepatitis B and C are acceptable if subject otherwise meets entry criteria (e.g., presence of hepatitis B surface antigen or positive hepatitis C test result within 3 months of screening)
- Monoclonal antibodies: Subjects who have received any monoclonal antibody within 5 half-lives of Visit 1.
- Investigational medications: Subjects 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).
- Hypersensitivity: Subjects with a known allergy or intolerance to another monoclonal antibody or biologic including history of anaphylaxis to another biologic
- Inability to read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete study related materials.
- Non-compliance: Subjects 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.
- Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
- Drug or alcohol abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
- Previous participation: Subjects who have previously participated in any study of mepolizumab.
- Affiliation with Investigator Site: 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. Randomization Criteria In order to be randomized to study drug the subject must meet the following randomization criteria at Visit 2:
- Blood eosinophils: Documented elevated peripheral blood eosinophil count of >=300 cells/microliter within the past 12 months prior to Visit 1; OR A peripheral baseline blood eosinophil count of >=150 cells/microliter from haematology conducted at Visit 1
- Electronic Diary Compliance: Compliance with completion of the eDiary defined as completion of all questions on 5 or more days out of the 7 days immediately preceding Visit 2.
- 12-lead ECG: No evidence of an abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1 as indicated on the over-read provided by the centralized independent cardiologist. Subjects with a QT interval corrected with Fridericia's formulas (QTcF)>=450 msec are not eligible. For subjects with a QRS interval >=120msec, those with QTcF>=480 msec are not eligible. Specific ECG findings that preclude subject eligibility are listed in the protocol.
- Abnormal chest X-ray (or Computerized Tomography [CT] scan): No chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. If a chest X-ray or CT scan is not available within 6 months prior to Visit 1, then a chest X-ray must be taken at Visit 1 and the results reviewed prior to randomization. For sites in Germany: If a chest X-ray (or CT scan) within 6 months prior to Screening (Visit 1) is not available, the subject will not be eligible for the study.
- Laboratory abnormality: No evidence of clinically significant abnormality in the haematological, biochemical, or urinalysis screen at Visit 1, as judged by the investigator.
- Hepatitis B: Subjects who are HBsAg positive or HBcAb positive must not have a HBV DNA level >=2000 International Units (IU)/millilitre (mL).
- Liver function test: Subjects must meet the following based on results from sample taken at Visit 1: Alanine aminotransferase (ALT) <2x ULN (upper limit of normal); Alkaline Phosphatase (Alk Phos) <=2x ULN; Bilirubin <=1.5x ULN (isolated bilirubin>1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent)
- Pregnancy: No subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.
Trial location(s)
Location
GSK Investigational Site
Gainesville, Florida, United States, 32608
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30173
Status
Study Complete
Location
GSK Investigational Site
Broomfield, Colorado, United States, 80023
Status
Study Complete
Location
GSK Investigational Site
Hershey, Pennsylvania, United States, 17033
Status
Study Complete
Location
GSK Investigational Site
Cheongju, Chungcheongbuk-do, South Korea, 361-711
Status
Study Complete
Location
GSK Investigational Site
Coeur D'Alene, Idaho, United States, 83814
Status
Study Complete
Location
GSK Investigational Site
Coffs Harbour, New South Wales, Australia, 2450
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Status
Study Complete
Location
GSK Investigational Site
Upland, California, United States, 91786
Status
Study Complete
Location
GSK Investigational Site
Sheffield, United Kingdom, S5 7AU
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Gastonia, North Carolina, United States, 28054
Status
Study Complete
Location
GSK Investigational Site
Trois Rivieres, Québec, Canada, G8T 7A1
Status
Study Complete
Location
GSK Investigational Site
Maroubra, New South Wales, Australia, 2035
Status
Study Complete
Location
GSK Investigational Site
Bucheon city, Gyenggi-do, South Korea, 420-767
Status
Study Complete
Location
GSK Investigational Site
Boynton Beach, Florida, United States, 33436
Status
Study Complete
Location
GSK Investigational Site
Wonju-si, Kanwon-do, South Korea, 220-701
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32825
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 8242238
Status
Study Complete
Location
GSK Investigational Site
Mt. Pleasant, South Carolina, United States, 29464
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Bowling Green, Kentucky, United States, 42101
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23225
Status
Study Complete
Location
GSK Investigational Site
St-Charles-Borromée, Québec, Canada, J6E 2B4
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23249
Status
Study Complete
Location
GSK Investigational Site
Anyang-Si Gyeonggi-do, South Korea, 431-070
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bahía Blanca, Buenos Aires, Argentina, B8000AAK
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70378
Status
Study Complete
Location
GSK Investigational Site
Valparaiso, Valparaíso, Chile, 2341131
Status
Study Complete
Location
GSK Investigational Site
Murdoch, Western Australia, Australia, 6150
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Adairsville, Georgia, United States, 30103
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97220
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23552
Status
Study Complete
Location
GSK Investigational Site
Oaks, Pennsylvania, United States, 19456
Status
Study Complete
Location
GSK Investigational Site
Edgewater, Florida, United States, 32132
Status
Study Complete
Location
GSK Investigational Site
La Plata, Buenos Aires, Argentina, 1900
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1414AIF
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina, 7600
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
Status
Study Complete
Location
GSK Investigational Site
Easley, South Carolina, United States, 29640
Status
Study Complete
Location
GSK Investigational Site
Huntersville, North Carolina, United States, 28078
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Stamford, Connecticut, United States, 06902
Status
Study Complete
Location
GSK Investigational Site
Rock Hill, South Carolina, United States, 29732
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33704
Status
Study Complete
Location
GSK Investigational Site
Ruedersdorf, Brandenburg, Germany, 15562
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Talca, Región Del Maule, Chile, 3460001
Status
Study Complete
Location
GSK Investigational Site
Woodstock, Georgia, United States, 30189
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
Status
Study Complete
Location
GSK Investigational Site
Morgantown, West Virginia, United States, 26505
Status
Study Complete
Location
GSK Investigational Site
Abingdon, Virginia, United States, 24210
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109-
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Anyang-Si Gyeonggi-do, South Korea, 431-07
Status
Study Complete
Location
GSK Investigational Site
Avon, Indiana, United States, 46123
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21224
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1425F
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Burlington, North Carolina, United States, 27215
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Clearwater, Florida, United States, 33756
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Columbus, Georgia, United States, 31904
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Columbus, Ohio, United States, 43215
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Council Bluffs, Iowa, United States, 51503
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Dayton, Ohio, United States, 45459
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Denver, Colorado, United States, 80206
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Durham, North Carolina, United States, 27705
Status
Terminated/Withdrawn
Location
GSK Investigational Site
East Dundee, Illinois, United States, 60118
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16506
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Flagstaff, Arizona, United States, 86001
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fort Mill, South Carolina, United States, 29707
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hartford, Connecticut, United States, 06105
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hazard, Kentucky, United States, 41701
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Iowa City, Iowa, United States, 52242
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lafayette, Indiana, United States, 47904
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Loewenstein, Baden-Wuerttemberg, Germany, 74245
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Marlton, New Jersey, United States, 08053
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Medford, Oregon, United States, 97504
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Miami, Florida, United States, 33015
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Muncie, Indiana, United States, 47304-
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New Haven, Connecticut, United States, 06520
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10029
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Newport Beach, California, United States, 92663
Status
Terminated/Withdrawn
Location
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85006
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85018
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Portsmouth, Hampshire, United Kingdom, PO6 3L
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rincon, Georgia, United States, 31326
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rochester, New York, United States, 14642
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Diego, California, United States, 92103
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Miguel de Tucumán, Argentina, 4000
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Seneca, South Carolina, United States, 29678
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Shelby, North Carolina, United States, 28152
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St-Charles-Borromée, Québec, Canada, J6E 2B
Status
Study Complete
Location
GSK Investigational Site
St. Charles, Missouri, United States, 63301
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70372
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Topeka, Kansas, United States, 66606
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Toronto, Ontario, Canada, M3J 2C
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Torrance, California, United States, 90505
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Trois Rivieres, Québec, Canada, G8T 7A
Status
Study Complete
Location
GSK Investigational Site
Tucson, Arizona, United States, 85723
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tucson, Arizona, United States, 85724-
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20037
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Terminated/Withdrawn
Study documents
Protocol
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
2017-16-01
Actual study completion date
2017-16-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
IPD for this study will be made available via the Clinical Study Data Request site.
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