Trial · NCT01520909
Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.
NCT01520909, Phase 3, Completed, GlaxoSmithKline; results first posted 2014-09-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body. Trials, record NCT01520909. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01520909
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.
- NCT number
- NCT01520909
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 92 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Interventions
- Eltrombopag, Placebo
- First posted
- 2012-01-30
- Last updated
- 2015-03-10
- Other registries' IDs
- eudract:2011-002184-17
- Results first posted
- 2014-09-29
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) for at Least 6 Out of 8 Weeks, Between Weeks 5 and 12 of Part 1 | From Week 5 up to Week 12 of Part 1 | Participants who achieved a platelet count \>=50 Gi/L for at least 6 out of 8 weeks, between Weeks 5 and 12 of Part 1, were reported. |
| Secondary | Percentage of Responders | From Week 1 up to Week 12 of Part 1 | Percentage of participants who responded (defined as platelet count \>= 50 Gi/L in absence of rescue) at least once up to week 12 of Part 1 (Odds of achieving a platelet count \>=50 Gi/L during the first 12 weeks of Part 1) |
| Secondary | Number of Participants Achieving a Platelet Count >=50 Gi/L at Any Time During the First 12 Weeks of Part 1 | From Baseline up to Week 12 of Part 1 | Participants who achieved a platelet count \>=50 Gi/L at any time during the first 12 weeks of Part 1 were reported. |
| Secondary | Number of Participants Achieving a Platelet Count >=50 Gi/L at Any Time During the First 6 Weeks of Part 1 | From Baseline up to Week 6 of Part 1 | Participants who achieved a platelet count \>=50 Gi/L at any time during the first 6 weeks of Part 1 were reported. |
| Secondary | Weighted Mean Platelet Count | Baseline and Week 12 of Part 1 | The weighted mean platelet count is defined as "the area under the platelet-time curve divided by the duration of the study (12 weeks)". Weighted mean platelet counts from baseline to week 12 of the randomized period was compared between placebo and eltrombopag using an analysis of covariance model (ANCOVA) adjusting for baseline platelet count and age cohort. For each subject the area between two adjacent visits with platelet counts was calculated. The area was calculated for all pairs of adjacent visits starting at Day 1 of randomized period and then the total sum of all the areas was divided by the total duration of time during the randomized period. For each subject, this method calculates an 'average' platelet count and it allows the possibility that subjects may have had different number of assessments during different times relative to baseline. |
| Secondary | Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the First 12 Weeks of Part 1 | From Baseline up to Week 12 of Part 1 | The maximum duration for which a participant continuously maintained a platelet count \>=50 Gi/L was calculated and summarized for the first 12 weeks of Part 1. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a participant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. |
| Secondary | Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 1 | From Baseline up to Week 12 of Part 1 | Rescue treatment is defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy. |
| Secondary | Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 1 | From Baseline through Follow-up of Part 1 | The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0=no bleeding; Grade 1=petechiae; Grade 2=mild blood loss; Grade 3=gross bleeding; Grade 4=debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. Baseline was defined as the Day 1 assessment or the latest possible screening assessment. |
| Secondary | Number of Participants Who Achieved a Platelet Count >=50 Gi/L at Any Time During Part 2 | From Baseline up to Week 24 of Part 2 | Participants who achieved a platelet count \>=50 Gi/L at any time during Part 2 (up to Week 24) were reported. |
| Secondary | Number of Weeks in Which Participants Achieved a Platelet Count >=50 Gi/L, Between Weeks 4 and 24 of Part 2 | From Week 4 up to Week 24 of Part 2 | Platelet response was analyzed after Week 4 for the eltrombopag-only period to allow participants who had been randomized to placebo in the Randomized Period time to escalate to their optimal dose of eltrombopag. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If the participant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) for at Least 6 Out of 8 Weeks, Between Weeks 5 and 12 of Part 1 | From Week 5 up to Week 12 of Part 1 | Intent-to-Treat (ITT) Population: all randomized participants. The ITT Population was the primary population used for assessing efficacy. | Participants | NUMBER |
| SECONDARY | Percentage of Responders | From Week 1 up to Week 12 of Part 1 | ITT Population | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Achieving a Platelet Count >=50 Gi/L at Any Time During the First 12 Weeks of Part 1 | From Baseline up to Week 12 of Part 1 | ITT Population | Participants | NUMBER |
| SECONDARY | Number of Participants Achieving a Platelet Count >=50 Gi/L at Any Time During the First 6 Weeks of Part 1 | From Baseline up to Week 6 of Part 1 | ITT Population | Participants | NUMBER |
| SECONDARY | Weighted Mean Platelet Count | Baseline and Week 12 of Part 1 | ITT Population. Only those participants with a value at Baseline and post-Baseline were analyzed. | Gi/L | MEAN |
| SECONDARY | Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the First 12 Weeks of Part 1 | From Baseline up to Week 12 of Part 1 | ITT Population | Weeks | MEAN |
| SECONDARY | Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 1 | From Baseline up to Week 12 of Part 1 | ITT Population | Participants | NUMBER |
| SECONDARY | Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 1 | From Baseline through Follow-up of Part 1 | ITT Population. Only those participants that did not enroll in Part 2 were analyzed during the follow-up visits. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). | Participants | NUMBER |
| SECONDARY | Number of Participants Who Achieved a Platelet Count >=50 Gi/L at Any Time During Part 2 | From Baseline up to Week 24 of Part 2 | ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Weeks in Which Participants Achieved a Platelet Count >=50 Gi/L, Between Weeks 4 and 24 of Part 2 | From Week 4 up to Week 24 of Part 2 | ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed. | Weeks | MEAN |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group764
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) for at Least 6 Out of 8 Weeks, Between Weeks 5 and 12 of Part 1 | Part 1 (Randomized Period)- Placebo | 1 | Participants | ||
| Number of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) for at Least 6 Out of 8 Weeks, Between Weeks 5 and 12 of Part 1 | Part 1 (Randomized Period)-Eltrombopag | 25 | Participants | ||
| Percentage of Responders | Part 1 (Randomized Period)-Placebo | Week 1 | 0 | Percentage of participants | |
| Percentage of Responders | Part 1 (Randomized Period) - Eltrombopag | Week 1 | 15.9 | Percentage of participants | |
| Percentage of Responders | Part 1 (Randomized Period)-Placebo | Week 2 | 3.4 | Percentage of participants | |
| Percentage of Responders | Part 1 (Randomized Period) - Eltrombopag | Week 2 | 23.8 | Percentage of participants | |
| Percentage of Responders | Part 1 (Randomized Period)-Placebo | Week 3 | 0 | Percentage of participants | |
| Percentage of Responders | Part 1 (Randomized Period) - Eltrombopag | Week 3 | 31.7 | Percentage of participants | |
| Percentage of Responders | Part 1 (Randomized Period)-Placebo | Week 4 | 6.9 | Percentage of participants | |
| Percentage of Responders | Part 1 (Randomized Period) - Eltrombopag | Week 4 | 36.5 | Percentage of participants |
1 to 10 of 764Source ClinicalTrials.gov
See all 764 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 (Randomized Period) | STARTED | Part 1 (Randomized Period)-Placebo | 29 | |
| Part 1 (Randomized Period) | STARTED | Part 1 (Randomized Period)-Eltrombopag | 63 | |
| Part 1 (Randomized Period) | STARTED | Part 2 (Open-Label Period) Eltrombopag | 0 | |
| Part 1 (Randomized Period) | COMPLETED | Part 1 (Randomized Period)-Placebo | 28 | |
| Part 1 (Randomized Period) | COMPLETED | Part 1 (Randomized Period)-Eltrombopag | 61 | |
| Part 1 (Randomized Period) | COMPLETED | Part 2 (Open-Label Period) Eltrombopag | 0 | |
| Part 1 (Randomized Period) | NOT COMPLETED | Part 1 (Randomized Period)-Placebo | 1 | |
| Part 1 (Randomized Period) | NOT COMPLETED | Part 1 (Randomized Period)-Eltrombopag | 2 | |
| Part 1 (Randomized Period) | NOT COMPLETED | Part 2 (Open-Label Period) Eltrombopag | 0 | |
| Part 2 (Open-Label Period)-Eltrombopag | STARTED | Part 1 (Randomized Period)-Placebo | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events480
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Part 1: Eltrombopag | 11 | 63 | |
| other | Nasopharyngitis | Infections and infestations | Part 1: Placebo | 2 | 29 | |
| other | Nasopharyngitis | Infections and infestations | Part 2: Eltrombopag | 7 | 87 | |
| other | Rhinitis | Infections and infestations | Part 1: Eltrombopag | 10 | 63 | |
| other | Rhinitis | Infections and infestations | Part 1: Placebo | 2 | 29 | |
| other | Rhinitis | Infections and infestations | Part 2: Eltrombopag | 3 | 87 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Part 1: Eltrombopag | 8 | 63 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Part 1: Placebo | 5 | 29 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Part 2: Eltrombopag | 11 | 87 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Part 1: Eltrombopag | 7 | 63 |
1 to 10 of 480Source ClinicalTrials.gov
See all 480 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Eltrombopag | ||
| Total, all-cause mortality | Part 1: Placebo | ||
| Total, all-cause mortality | Part 2: Eltrombopag | ||
| Total, other adverse events | Part 1: Eltrombopag | 51 | 63 |
| Total, other adverse events | Part 1: Placebo | 19 | 29 |
| Total, other adverse events | Part 2: Eltrombopag | 68 | 87 |
| Total, serious adverse events | Part 1: Eltrombopag | 5 | 63 |
| Total, serious adverse events | Part 1: Placebo | 4 | 29 |
| Total, serious adverse events | Part 2: Eltrombopag | 9 | 87 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Part 1 (Randomized Period) - Eltrombopag vs Part 1 (Randomized Period)-Placebo: Number of Participants Achieving a Platelet Count >=50 Gi/L at Any Time During the First 12 Weeks of Part 1 | Trial comparisons |
Part 1 (Randomized Period)-Eltrombopag vs Part 1 (Randomized Period)- Placebo: Number of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) for at Least 6 Out of 8 Weeks, Between Weeks 5 and 12 of Part 1 | Trial comparisons |
| Part 1 (Randomized Period) - Eltrombopag vs Part 1 (Randomized Period)-Placebo: Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 1 | Trial comparisons |
| Part 1 (Randomized Period)-Eltrombopag vs Part 1 (Randomized Period)-Placebo: Number of Participants Achieving a Platelet Count >=50 Gi/L at Any Time During the First 6 Weeks of Part 1 | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01520909
GET https://conductscience.org/api/trials/v1/NCT01520909/registered?page=2