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Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP) (PETIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00908037
First received: May 21, 2009
Last updated: October 30, 2014
Last verified: October 2014
Results First Received: September 29, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Purpura, Thrombocytopaenic, Idiopathic
Interventions: Drug: eltrombopag
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Pediatric participants (par.) meeting eligibility criteria were enrolled into 3 cohorts depending upon age. Cohort 1 enrolled participants who were between 12 and 17 years old, Cohort 2 enrolled participants who were between 6 and 11 years old, and Cohort 3 enrolled participants who were between 1 and 5 years old.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
15 par. were randomized to a 24-Week (Wk) Open-Label (OL) eltrombopag Dose-Finding period (pd) (Part 1) then did not continue. 67 par. were randomized to a 7-Wk Double-Blind placebo-controlled pd (Part 2), followed by a 24-Wk OL eltrombopag-only pd (Part 2/3) and a 4-Wk Follow-Up pd.

Reporting Groups
  Description
Part 1 (Dose-Finding Period) Cohort 1 Participants aged between 12 and 17 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 1 (Dose-Finding Period) Cohort 2 Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 1 (Dose-Finding Period) Cohort 3 Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 1-Placebo Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2/3 (Eltrombopag Open-Label Period) Cohort 1 All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2/3 (Eltrombopag Open-Label Period) Cohort 2 All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2/3 (Eltrombopag Open- Label Period) Cohort 3 All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.

Participant Flow for 3 periods

Period 1:   Part1 (24 Week Dose-Finding Period)
    Part 1 (Dose-Finding Period) Cohort 1     Part 1 (Dose-Finding Period) Cohort 2     Part 1 (Dose-Finding Period) Cohort 3     Part 2 (Randomized Period) Cohort 1-Placebo     Part 2 (Randomized Period) Cohort 1- Eltrombopag     Part 2 (Randomized Period) Cohort 2-Placebo     Part 2 (Randomized Period) Cohort 2-Eltrombopag     Part 2 (Randomized Period) Cohort 3-Placebo     Part 2 (Randomized Period) Cohort 3- Eltrombopag     Part 2/3 (Eltrombopag Open-Label Period) Cohort 1     Part 2/3 (Eltrombopag Open-Label Period) Cohort 2     Part 2/3 (Eltrombopag Open- Label Period) Cohort 3  
STARTED     5     5     5     0     0     0     0     0     0     0     0     0  
COMPLETED     5 [1]   5 [1]   5 [1]   0     0     0     0     0     0     0     0     0  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     0     0     0  
[1] Participants who completed Part 1 did not enroll in Parts 2 or 2/3

Period 2:   Part 2 (7 Week Randomized Period)
    Part 1 (Dose-Finding Period) Cohort 1     Part 1 (Dose-Finding Period) Cohort 2     Part 1 (Dose-Finding Period) Cohort 3     Part 2 (Randomized Period) Cohort 1-Placebo     Part 2 (Randomized Period) Cohort 1- Eltrombopag     Part 2 (Randomized Period) Cohort 2-Placebo     Part 2 (Randomized Period) Cohort 2-Eltrombopag     Part 2 (Randomized Period) Cohort 3-Placebo     Part 2 (Randomized Period) Cohort 3- Eltrombopag     Part 2/3 (Eltrombopag Open-Label Period) Cohort 1     Part 2/3 (Eltrombopag Open-Label Period) Cohort 2     Part 2/3 (Eltrombopag Open- Label Period) Cohort 3  
STARTED     0     0     0     8     16     9     19     5     10     0     0     0  
COMPLETED     0     0     0     7     13     9     15     5     5     0     0     0  
NOT COMPLETED     0     0     0     1     3     0     4     0     5     0     0     0  
Protocol Violation                 0                 0                 0                 0                 1                 0                 3                 0                 1                 0                 0                 0  
Lost to Follow-up                 0                 0                 0                 0                 2                 0                 0                 0                 4                 0                 0                 0  
Withdrawal by parent/ guardian                 0                 0                 0                 1                 0                 0                 1                 0                 0                 0                 0                 0  

Period 3:   Part 2/3(Eltrombopag Open-Label Period)
    Part 1 (Dose-Finding Period) Cohort 1     Part 1 (Dose-Finding Period) Cohort 2     Part 1 (Dose-Finding Period) Cohort 3     Part 2 (Randomized Period) Cohort 1-Placebo     Part 2 (Randomized Period) Cohort 1- Eltrombopag     Part 2 (Randomized Period) Cohort 2-Placebo     Part 2 (Randomized Period) Cohort 2-Eltrombopag     Part 2 (Randomized Period) Cohort 3-Placebo     Part 2 (Randomized Period) Cohort 3- Eltrombopag     Part 2/3 (Eltrombopag Open-Label Period) Cohort 1     Part 2/3 (Eltrombopag Open-Label Period) Cohort 2     Part 2/3 (Eltrombopag Open- Label Period) Cohort 3  
STARTED     0     0     0     0     0     0     0     0     0     24     28 [1]   15  
COMPLETED     0     0     0     0     0     0     0     0     0     21     24 [1]   12  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     3     4     3  
Lack of Efficacy                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1  
Lost to Follow-up                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1                 0                 2  
Withdrawal by parent/guardian                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1                 0                 0  
Adverse Event                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 2                 0  
Physician Decision                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1                 0                 0  
Randomized but did not receive treatment                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 2                 0  
[1] Two participants were randomized but did not receive treatment.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Part 1 Eltrombopag Dose-Finding Period Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For Cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of East Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
Part 2 (Randomized Period) Cohort 1-Placebo Par aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par who received placebo in Part 2 received 24 weeks of OL treatment of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 1- Eltrombopag Par aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo Par aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Par who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Par with a body weight of &lt;=27 kg received 25 mg QD and par with a body weight of &gt;=27 kg QD received 50 mg QD. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Eltrombopag Par aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, par with a weight of &lt;27 kg received 25 mg QD and par with a weight of &gt;=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of &lt;27 kg received 12.5 mg QD and par with a weight of &gt;=27 kg received 25 mg QD. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo Par aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Par who received placebo in Part 2 received 24 weeks of OL treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Par of East Asian ancestry received 0.8 mg/kg/day. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3- Eltrombopag Par aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Par of East Asian ancestry began at 0.8 mg/kg/day. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
Total Total of all reporting groups

Baseline Measures
    Part 1 Eltrombopag Dose-Finding Period     Part 2 (Randomized Period) Cohort 1-Placebo     Part 2 (Randomized Period) Cohort 1- Eltrombopag     Part 2 (Randomized Period) Cohort 2-Placebo     Part 2 (Randomized Period) Cohort 2-Eltrombopag     Part 2 (Randomized Period) Cohort 3-Placebo     Part 2 (Randomized Period) Cohort 3- Eltrombopag     Total  
Number of Participants  
[units: participants]
  15     8     16     9     19     5     10     82  
Age  
[units: Years]
Mean ± Standard Deviation
  9.1  ± 4.61     14.6  ± 1.69     13.7  ± 1.58     8.6  ± 2.24     8.2  ± 1.87     3.6  ± 1.34     3.3  ± 1.34     9.3  ± 4.49  
Gender  
[units: Participants]
               
Female     8     3     8     8     14     2     5     48  
Male     7     5     8     1     5     3     5     34  
Race/Ethnicity, Customized  
[units: Participants]
               
African American/African Heritage     2     0     0     0     1     0     0     3  
Asian – Japanese/East Asian Heritage     2     1     0     1     1     0     1     6  
White – White/Caucasian/European     9     7     14     8     17     5     7     67  
Unknown     1     0     0     0     0     0     0     1  
White - Arabic/North African Heritage     0     0     1     0     0     0     1     2  
Mixed Race     1     0     1     0     0     0     1     3  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) at Least Once, Between Day 8 and Day 43 (Weeks 1 to 6) of the Randomized Period of the Study (Part 2)   [ Time Frame: From Day 8 up to Day 43 of Part 2 ]

2.  Secondary:   Percentage of Participants Achieving Platelet Counts >=50Gi/L During Treatment With Eltrombopag in >= 60% of Assessments Between Day 15 and Day 43 (Weeks 2 Through 6) of the Randomized Treatment Period (Part 2)   [ Time Frame: Between Day 15 and Day 43 of Part 2 ]

3.  Secondary:   Weighted Mean Platelet Count   [ Time Frame: Baseline and Day 43 of Part 2 ]

4.  Secondary:   Percentage of Participants Achieving Platelet Counts >=50Gi/L at Any Time During the 24 Weeks of Eltrombopag Dosing During Part 1.   [ Time Frame: From Day 1 of treatment up to Week 24 of Part 1 ]

5.  Secondary:   Percentage of Participants Achieving Platelet Counts >=50 Gi/L at Any Time During the 31 Weeks of Eltrombopag Treatment During Part 2/ 3.   [ Time Frame: Part 2/3 up to Study Week 31 ]

6.  Secondary:   Population Pharmacokinetic (PK) Assessment for Eltrombopag for AUC(0-t) During Part 1, 2, and 2/3.   [ Time Frame: From Day 1 of treatment up to Study Week 31 ]

7.  Secondary:   Population Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax and Ct During Part 1, 2, and 2/3.   [ Time Frame: From Day 1 of treatment up to Study Week 31 ]

8.  Secondary:   Population Pharmacokinetic (PK) Assessments for Eltrombopag for Tmax During Part 1, 2, and 2/3   [ Time Frame: From Day 1 of treatment up to Study Week 31 ]

9.  Secondary:   Population Pharmacokinetic (PK) Assessments for Eltrombopag for CL/F During Part 1, 2, and 2/3   [ Time Frame: From Day 1 of treatment up to Study Week 31 ]

10.  Secondary:   Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 7 Weeks of Eltrombopag Treatment in Part 2   [ Time Frame: From Baseline through Week 7 of Part 2 ]

11.  Secondary:   Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 24 Weeks of Eltrombopag Treatment in Part 2/ 3   [ Time Frame: From Baseline up to Study Week 31 ]

12.  Secondary:   Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1.   [ Time Frame: From Baseline up to Week 24+ 1 day of Part 1 ]

13.  Secondary:   Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3   [ Time Frame: From Baseline to the end of treatment up to Week 31 + 1 day of Part 2/3 ]

14.  Secondary:   Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3   [ Time Frame: From Baseline to the end of treatment up to Week 31 + 1 day of Part2/3 ]

15.  Secondary:   Kids’ ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1   [ Time Frame: Baseline, Week 6, Week 12, and Week 24 of Part 1 ]

16.  Secondary:   Kids’ ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2   [ Time Frame: Baseline and Week 6 of Part 2 ]

17.  Secondary:   Kids’ ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3   [ Time Frame: From Baseline to end of treatment up to Study Week 31 ]

18.  Secondary:   Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2   [ Time Frame: From Baseline through Week 7 of Part 2 ]

19.  Secondary:   Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3   [ Time Frame: From Baseline of Part 2/3 through Follow-up ]

20.  Secondary:   Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3   [ Time Frame: Post-Baseline from Week 1 through Follow-up up to Study Week 35 ]

21.  Secondary:   Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3   [ Time Frame: Post-Baseline from Week 1 through Follow-up up to Study Week 35 ]

22.  Secondary:   Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3   [ Time Frame: Post-Baseline from Week 1 through Follow-up up to Study Week 35 ]

23.  Secondary:   Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1   [ Time Frame: From Baseline up to Study Week 24 of Part 1 ]

24.  Secondary:   Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2   [ Time Frame: From Baseline and post-Baseline up to Study Week 7 of Part 2 ]

25.  Secondary:   Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3   [ Time Frame: From Baseline and post-Baseline up to Study Week 31 of Part 2/3 ]

26.  Secondary:   Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3   [ Time Frame: From Baseline through Study Week 35 ]

27.  Secondary:   Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1   [ Time Frame: From Baseline through Week 24 ]

28.  Secondary:   Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2   [ Time Frame: From Week 1 to Week 7 of Part 2 ]

29.  Secondary:   Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3   [ Time Frame: From Week 1 to Follow-up Week 4 of Part 2/3 up to Study Week 35 ]

30.  Secondary:   Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1   [ Time Frame: From Week 1 to Follow-up Week 4 of Part 1, up to Study Week 28 ]

31.  Secondary:   Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2   [ Time Frame: From Week 1 to Week 7 of Part 2 ]

32.  Secondary:   Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3   [ Time Frame: From Week 1to Follow-up Week 4 of Part 2/3, up to Study Week 35 ]

33.  Secondary:   Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1   [ Time Frame: Baseline and Week 24 of Part 1 ]

34.  Secondary:   Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2   [ Time Frame: Baseline and Week 7 of Part 2 ]

35.  Secondary:   Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3   [ Time Frame: Baseline and Week 24 of Part 2/3 up to Study Week 31 ]

36.  Secondary:   Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1   [ Time Frame: From Treatment + 1 day up to Week 24 of Part1 ]

37.  Secondary:   Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2   [ Time Frame: From Treatment + 1 day up to Week 7 of Part 2 ]

38.  Secondary:   Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3   [ Time Frame: From Treatment + 1 day up to Week 31 of Part2/3 ]

39.  Secondary:   Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1   [ Time Frame: Baseline, 3and 6-mo Follow-up of Part 1 ]

40.  Secondary:   Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts   [ Time Frame: BL, 3 and 6mo Follow-up of Part 2/3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00908037     History of Changes
Other Study ID Numbers: 108062
Study First Received: May 21, 2009
Results First Received: September 29, 2014
Last Updated: October 30, 2014
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
France: Agence Française de Sécurité Sanitaire des Produits de Santé
United States: Food and Drug Administration