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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00529568




Registration number
NCT00529568
Ethics application status
Date submitted
12/09/2007
Date registered
14/09/2007
Date last updated
5/11/2013

Titles & IDs
Public title
Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C Liver Disease
Scientific title
Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2b Plus Ribavirin)
Secondary ID [1] 0 0
TPL108390
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - eltrombopag
Treatment: Drugs - placebo

Experimental: eltrombopag - active treatment arm

Placebo comparator: placebo - placebo control arm


Treatment: Drugs: eltrombopag
double-blind active treatment daily oral administation at dose of 25, 50, 75, or 100 mg

Treatment: Drugs: placebo
double-blind matched placebo control daily oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase
Assessment method [1] 0 0
Participants with SVR are defined as those with non-detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the end of treatment and all subsequent planned visits up to 24 weeks post-completion of the treatment period of the DB Phase.
Timepoint [1] 0 0
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Secondary outcome [1] 0 0
Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 100 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase
Assessment method [1] 0 0
Participants were assessed for a shift from a baseline platelet count of \<75 Gi/L to a count \>=100 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.
Timepoint [1] 0 0
From Baseline up to Week 9 in the OL Phase
Secondary outcome [2] 0 0
Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase
Assessment method [2] 0 0
In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was \<100 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained \<100 Gi/L. Participants who achieved platelet counts \>=100 Gi/L when receiving any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.
Timepoint [2] 0 0
From Baseline up to Week 9 in the OL Phase
Secondary outcome [3] 0 0
Median Platelet Count at the Indicated Time Points During the OL Phase
Assessment method [3] 0 0
Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.
Timepoint [3] 0 0
OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)
Secondary outcome [4] 0 0
Median Platelet Count at the Indicated Time Points During the DB Phase
Assessment method [4] 0 0
Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.
Timepoint [4] 0 0
DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
Secondary outcome [5] 0 0
Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy
Assessment method [5] 0 0
The minimum platelet count with antiviral therapy was categorized as follows: \<25 Gi/L; \>=25 to \<50 Gi/L; \>=50 to \<90 Gi/L; \>=90 to \<150 Gi/L; \>=150 Gi/L to \<200 Gi/L; \>=200 Gi/L to \<400 Gi/L; and \>=400 Gi/L.
Timepoint [5] 0 0
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Secondary outcome [6] 0 0
Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase
Assessment method [6] 0 0
RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.
Timepoint [6] 0 0
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Secondary outcome [7] 0 0
Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase
Assessment method [7] 0 0
EVR is defined as a clinically significant reduction from Baseline in HCV RNA (\>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. cEVR is defined as undetectable HCV RNA after 12 weeks of antiviral treatment.
Timepoint [7] 0 0
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Secondary outcome [8] 0 0
Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase
Assessment method [8] 0 0
ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.
Timepoint [8] 0 0
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Secondary outcome [9] 0 0
Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase
Assessment method [9] 0 0
Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions \[DRs\]; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). When possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, when dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.
Timepoint [9] 0 0
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Secondary outcome [10] 0 0
Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase
Assessment method [10] 0 0
Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.
Timepoint [10] 0 0
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Secondary outcome [11] 0 0
Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase
Assessment method [11] 0 0
The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (µg). For peginterferon dose modification, downward adjustments in one-level increments were considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 µg. When dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 µg was generally adequate. In some cases, a dose reduction to 90 µg or 45 µg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.
Timepoint [11] 0 0
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Secondary outcome [12] 0 0
Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase
Assessment method [12] 0 0
The following participants were considered to have discontinued antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.
Timepoint [12] 0 0
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Secondary outcome [13] 0 0
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3)
Assessment method [13] 0 0
There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. IL28B genotype distribution by response to antiviral therapy (SVR/RVR responders: those who achieved SVR/RVR; SVR/RVR non-responders: those who did not achieve SVR/RVR) was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.
Timepoint [13] 0 0
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Secondary outcome [14] 0 0
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS)
Assessment method [14] 0 0
Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
Timepoint [14] 0 0
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Secondary outcome [15] 0 0
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS
Assessment method [15] 0 0
Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
Timepoint [15] 0 0
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Secondary outcome [16] 0 0
Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication
Assessment method [16] 0 0
Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.
Timepoint [16] 0 0
From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Secondary outcome [17] 0 0
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase
Assessment method [17] 0 0
Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.
Timepoint [17] 0 0
DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)
Secondary outcome [18] 0 0
Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase
Assessment method [18] 0 0
Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS and a NCS change from baseline in ECG status, as determined by the Investigator, was reported. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. "Not applicable" indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS.
Timepoint [18] 0 0
End of Treatment (up to Week 52); and 24-week FU (up to Week 72)
Secondary outcome [19] 0 0
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase
Assessment method [19] 0 0
Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
Timepoint [19] 0 0
DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
Secondary outcome [20] 0 0
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase
Assessment method [20] 0 0
Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
Timepoint [20] 0 0
DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
Secondary outcome [21] 0 0
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase
Assessment method [21] 0 0
The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
Timepoint [21] 0 0
DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
Secondary outcome [22] 0 0
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase
Assessment method [22] 0 0
The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
Timepoint [22] 0 0
DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

Eligibility
Key inclusion criteria
Male and female subjects, >18 years Evidence of chronic hepatitis C virus (HCV) infection Subjects who are appropriate candidates for peginterferon (pegIFN) and ribavirin antiviral therapy A platelet count of <75,000/mcL Haemoglobin >11.0g/dL for men or >10.0g/dL for women Absolute neutrophil count (ANC) >750/mm3 and no history of infections associated with neutropenia Creatinine clearance >50mL/minute All fertile males and females must use two forms of effective contraception between them during treatment and during the 24 weeks after treatment end Subject is able to understand, consent and comply with protocol requirements and instructions and is likely to complete the study as planned
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

Non-responders to previous treatment with pegIFN and ribavirin who failed to achieve a sustained virologic response (SVR) for reasons other than thrombocytopenia, despite an optimal course (dose and duration) of combination therapy with pegIFN and ribavirin Decompensated liver disease, e.g. Child-Pugh score >6 or history of ascites or hepatic encephalopathy or current evidence of ascites Known hypersensitivity, intolerance or allergy to interferon (IFN), ribavirin, eltrombopag or any of their ingredients Serious cardiac, cerebrovascular, or pulmonary disease that would preclude treatment with pegIFN and ribavirin

Subjects with a history of any one of the following:

Suicide attempt or hospitalisation for depression in the past 5 years Any current severe or poorly controlled psychiatric disorder

The following subjects are eligible for study participation, but must be assessed and followed (if recommended) by a mental health professional:

* Subjects who have had a severe or poorly controlled psychiatric disorder more than 6 months ago but less than 5 years ago
* Seizure disorder that has not been well controlled History of clinically significant bleeding from oesophageal or gastric varices Subjects with haemoglobinopathies, e.g. sickle cell anaemia, thalassemia major Any prior history of arterial or venous thrombosis AND two or more of the following risk factors: hereditary thrombophilic disorders (e.g. Factor V Leiden, ATIII deficiency, etc), hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension or cancer Pre-existing cardiac disease (New York Heart Association (NYHA) Grade III/IV), or arrhythmias known to involve the risk of thromboembolic events, or corrected QT interval (QTc) >450 msec Evidence of hepatocellular carcinoma Laboratory evidence of infection with human immunodeficiency virus (HIV) or active Hepatitis B Virus (HBV) infection Any disease condition associated with active bleeding or requiring anticoagulation with heparin or warfarin Therapy with any anti-neoplastic or immuno-modulatory treatment <6 months prior to the first dose of eltrombopag.

Subjects who have had a malignancy diagnosed and/or treated within the past 5 years, except for subjects with localised basal or squamous cell carcinoma treated by local excision or subjects with malignancies who have been adequately treated and, in the opinion of the oncologist, have an excellent chance of cancer-free survival Pregnant or nursing women Males with a female partner who is pregnant History of alcohol/drug abuse or dependence within 6 months of the study start (unless participating in a controlled rehabilitation programme) Treatment with an investigational drug or IFN within 30 days or 5 half-lives (whichever is longer) of the screening visit History of platelet clumping that prevents reliable measurement of platelet counts History of major organ transplantation with an existing functional graft Thyroid dysfunction not adequately controlled Subjects planning to have cataract surgery Evidence of portal vein thrombosis on abdominal imaging within 3 months of the baseline visit

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
Accrual to date
Final
759
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
Recruitment hospital [2] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [3] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [4] 0 0
GSK Investigational Site - Cairns
Recruitment hospital [5] 0 0
GSK Investigational Site - Herston
Recruitment hospital [6] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [7] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [8] 0 0
GSK Investigational Site - Parkville
Recruitment hospital [9] 0 0
GSK Investigational Site - Prahran
Recruitment hospital [10] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
4870 - Cairns
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
3181 - Prahran
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
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Illinois
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United States of America
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Indiana
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Kentucky
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United States of America
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Louisiana
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Massachusetts
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Michigan
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Mississippi
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Missouri
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New Hampshire
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New York
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North Carolina
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Oklahoma
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Oregon
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Pennsylvania
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United States of America
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Tennessee
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Belgium
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Bruxelles
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Leuven
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Brazil
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São Paulo
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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Czech Republic
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Hradec Kralove
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Czech Republic
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Olomouc
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Czech Republic
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Praha 6
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Egypt
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Cairo
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Egypt
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Mansoura
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Egypt
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Shebeen El-Kom, Menoufeya
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France
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Besançon
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France
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Bondy
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France
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Dijon cedex
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France
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Grenoble
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France
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Lille
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France
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Marseille Cedex 08
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France
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Orléans
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France
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Paris Cedex 12
Country [51] 0 0
France
State/province [51] 0 0
Paris Cedex 13
Country [52] 0 0
France
State/province [52] 0 0
Rouen
Country [53] 0 0
France
State/province [53] 0 0
Strasbourg
Country [54] 0 0
France
State/province [54] 0 0
Vandoeuvre Les Nancy
Country [55] 0 0
Germany
State/province [55] 0 0
Baden-Wuerttemberg
Country [56] 0 0
Germany
State/province [56] 0 0
Bayern
Country [57] 0 0
Germany
State/province [57] 0 0
Brandenburg
Country [58] 0 0
Germany
State/province [58] 0 0
Hessen
Country [59] 0 0
Germany
State/province [59] 0 0
Niedersachsen
Country [60] 0 0
Germany
State/province [60] 0 0
Nordrhein-Westfalen
Country [61] 0 0
Germany
State/province [61] 0 0
Rheinland-Pfalz
Country [62] 0 0
Germany
State/province [62] 0 0
Sachsen-Anhalt
Country [63] 0 0
Germany
State/province [63] 0 0
Sachsen
Country [64] 0 0
Germany
State/province [64] 0 0
Berlin
Country [65] 0 0
Germany
State/province [65] 0 0
Hamburg
Country [66] 0 0
Greece
State/province [66] 0 0
Athens
Country [67] 0 0
Greece
State/province [67] 0 0
Rio, Patras
Country [68] 0 0
Greece
State/province [68] 0 0
Thessaloniki
Country [69] 0 0
India
State/province [69] 0 0
Bangalore
Country [70] 0 0
India
State/province [70] 0 0
Chennai
Country [71] 0 0
India
State/province [71] 0 0
Hyderabad
Country [72] 0 0
India
State/province [72] 0 0
Mumbai
Country [73] 0 0
Israel
State/province [73] 0 0
Haifa
Country [74] 0 0
Israel
State/province [74] 0 0
Jerusalem
Country [75] 0 0
Israel
State/province [75] 0 0
Nazareth
Country [76] 0 0
Israel
State/province [76] 0 0
Petach Tikva
Country [77] 0 0
Israel
State/province [77] 0 0
Rehovot
Country [78] 0 0
Israel
State/province [78] 0 0
Safed
Country [79] 0 0
Israel
State/province [79] 0 0
Tel Aviv
Country [80] 0 0
Italy
State/province [80] 0 0
Calabria
Country [81] 0 0
Italy
State/province [81] 0 0
Campania
Country [82] 0 0
Italy
State/province [82] 0 0
Emilia-Romagna
Country [83] 0 0
Italy
State/province [83] 0 0
Lazio
Country [84] 0 0
Italy
State/province [84] 0 0
Liguria
Country [85] 0 0
Italy
State/province [85] 0 0
Lombardia
Country [86] 0 0
Italy
State/province [86] 0 0
Puglia
Country [87] 0 0
Italy
State/province [87] 0 0
Sicilia
Country [88] 0 0
Korea, Republic of
State/province [88] 0 0
Busan
Country [89] 0 0
Korea, Republic of
State/province [89] 0 0
Daegu
Country [90] 0 0
Korea, Republic of
State/province [90] 0 0
Pusan
Country [91] 0 0
Korea, Republic of
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Seoul
Country [92] 0 0
Pakistan
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Lahore
Country [93] 0 0
Poland
State/province [93] 0 0
Chorzow
Country [94] 0 0
Poland
State/province [94] 0 0
Kielce
Country [95] 0 0
Poland
State/province [95] 0 0
Raciborz
Country [96] 0 0
Poland
State/province [96] 0 0
Szczecin
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Poland
State/province [97] 0 0
Warszawa
Country [98] 0 0
Poland
State/province [98] 0 0
Wroclaw
Country [99] 0 0
Puerto Rico
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Ponce
Country [100] 0 0
Puerto Rico
State/province [100] 0 0
San Juan
Country [101] 0 0
Romania
State/province [101] 0 0
Bucharest
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Romania
State/province [102] 0 0
Constanta
Country [103] 0 0
Russian Federation
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Moscow
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Russian Federation
State/province [104] 0 0
Saint-Petersburg
Country [105] 0 0
Russian Federation
State/province [105] 0 0
Samara
Country [106] 0 0
Russian Federation
State/province [106] 0 0
St.Peterburg
Country [107] 0 0
Slovakia
State/province [107] 0 0
Bratislava
Country [108] 0 0
Slovakia
State/province [108] 0 0
Kosice
Country [109] 0 0
Slovakia
State/province [109] 0 0
Martin
Country [110] 0 0
Spain
State/province [110] 0 0
Alicante
Country [111] 0 0
Spain
State/province [111] 0 0
Barcelona
Country [112] 0 0
Spain
State/province [112] 0 0
La Coruña
Country [113] 0 0
Spain
State/province [113] 0 0
Madrid
Country [114] 0 0
Spain
State/province [114] 0 0
Málaga
Country [115] 0 0
Spain
State/province [115] 0 0
Palma de Mallorca
Country [116] 0 0
Spain
State/province [116] 0 0
Pontevedra
Country [117] 0 0
Spain
State/province [117] 0 0
Sabadell (Barcelona)
Country [118] 0 0
Spain
State/province [118] 0 0
San Sebastián
Country [119] 0 0
Spain
State/province [119] 0 0
Sevilla
Country [120] 0 0
Spain
State/province [120] 0 0
Valencia
Country [121] 0 0
Taiwan
State/province [121] 0 0
Changhua
Country [122] 0 0
Taiwan
State/province [122] 0 0
Chia-Yi Hsien
Country [123] 0 0
Taiwan
State/province [123] 0 0
Kaohsiung
Country [124] 0 0
Taiwan
State/province [124] 0 0
Taichung
Country [125] 0 0
Taiwan
State/province [125] 0 0
Taipei
Country [126] 0 0
Taiwan
State/province [126] 0 0
Taiyuan Hsien
Country [127] 0 0
Ukraine
State/province [127] 0 0
Donetsk
Country [128] 0 0
Ukraine
State/province [128] 0 0
Kiev
Country [129] 0 0
Ukraine
State/province [129] 0 0
Vinnitsa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Country

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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


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 are available at https://clinicaltrials.gov/study/NCT00529568