Trial · NCT00370331
RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag
NCT00370331, Phase 3, Completed, GlaxoSmithKline; results first posted 2010-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag. Trials, record NCT00370331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00370331
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag
- NCT number
- NCT00370331
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 197 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Purpura, Thrombocytopaenic, Idiopathic
- Interventions
- eltrombopag, Placebo
- First posted
- 2006-08-31
- Last updated
- 2017-04-18
- Results first posted
- 2010-02-23
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Responders | Baseline; each on-therapy treatment day; Weeks 10, 14, 18, 22, and 26; and Weeks 1, 2, and 4 post-treatment | The percentage of evaluable participants who achieved a platelet response (defined as a platelet count between 50,000 and 400,000 microliter) at each nominal on-therapy day and 4 weeks post-treatment |
| Secondary | Summary of Median Platelet Counts | Baseline; Day 8 through Week 26 on-treatment; and 1, 2, 4 week follow-up visits | Platelet counts were measured by blood draw. |
| Secondary | Percentage of Participants Initiating Rescue Treatment On-therapy | Anytime from Day 1 to Week 26 | Percentage of participants initiating new ITP medication, an increased dose of concomitant ITP medication from baseline, platelet transfusion, or splenectomy. |
| Secondary | Maximum and Total Weeks of Platelet Response | Day 1 through Week 26 on-treatment | Response is defined as a platelet count between 50,000 and 400,000 platelets per microliter. |
| Secondary | Percentage of Participants With a Reduction in Use of Baseline ITP Medication | From Day 1 through Week 26 on-treatment | Percentage of participants who experienced a reduction in their baseline concomitant ITP medication use |
| Secondary | WHO Bleeding Scale | Baseline, all nominal visits on-therapy defined as Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Week 10, Week 14, Week 18, Week 22, Week 26, and 1, 2 and 4 week follow-up visits | Summary of World Health Organization (WHO) bleeding scores at each nominal visit. WHO Grades 1-4 = any bleeding; WHO Grades 2-4 = clinically significant bleeding |
| Secondary | HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment | Baseline, Week 6, Week 14, and Week 26/Early Withdrawal | Health-related quality of life (HR-QoL) patient reported outcomes from the short form-36v2 (SF-36v2) questionnaire. Scores could range from 0 (worst possible) to 100 (best possible). |
| Secondary | HR-QoL Instrument and Domain Scores From the FACIT-F Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment | Baseline, Week 6, Week 14, and Week 26/Early Withdrawal | Health-related quality of life (HR-QoL) patient reported outcomes from the functional assessment of chronic illness therapy fatigue (FACIT-F) questionnaire. Scores could range from 0 (worst possible) to 52 (best possible). |
| Secondary | HR-QoL Instrument and Domain Scores for the FACT-Th Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment | Baseline, Week 6, Week 14, and Week 26/Early Withdrawal | Health-related quality of life (HR-QoL) patient reported outcomes from the functional assessment of cancer therapy thrombocytopenia (FACT-Th) questionnaire (six selected items). Scores could range from 0 (worst possible) to 24 (best possible). |
| Secondary | HR-QoL Instrument and Domain Scores From the MEI-SF Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment | Baseline, Week 6, Week 14, and Week 26/Early Withdrawal | Health-related quality of life (HR-QoL) patient reported outcomes from the motivation and energy inventory-short form (MEI-SF) questionnaire. Scores could range from 0 (worst possible) to 72 (best possible). |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Responders | Baseline; each on-therapy treatment day; Weeks 10, 14, 18, 22, and 26; and Weeks 1, 2, and 4 post-treatment | Intent-to-Treat (ITT) Population: all randomized participants | Percentage of participants | NUMBER |
| SECONDARY | Summary of Median Platelet Counts | Baseline; Day 8 through Week 26 on-treatment; and 1, 2, 4 week follow-up visits | ITT Population | platelets/microliter (ul) | MEDIAN |
| SECONDARY | Percentage of Participants Initiating Rescue Treatment On-therapy | Anytime from Day 1 to Week 26 | All participants randomized to receive placebo or eltrombopag treatment | Percentage of participants | NUMBER |
| SECONDARY | Maximum and Total Weeks of Platelet Response | Day 1 through Week 26 on-treatment | ITT Population | Weeks | MEDIAN |
| SECONDARY | Percentage of Participants With a Reduction in Use of Baseline ITP Medication | From Day 1 through Week 26 on-treatment | ITT Population | Percentage of participants | NUMBER |
| SECONDARY | WHO Bleeding Scale | Baseline, all nominal visits on-therapy defined as Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Week 10, Week 14, Week 18, Week 22, Week 26, and 1, 2 and 4 week follow-up visits | ITT Population | Percentage of participants | NUMBER |
| SECONDARY | HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment | Baseline, Week 6, Week 14, and Week 26/Early Withdrawal | ITT Population | Points on a scale (0-100) | MEAN |
| SECONDARY | HR-QoL Instrument and Domain Scores From the FACIT-F Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment | Baseline, Week 6, Week 14, and Week 26/Early Withdrawal | ITT Population | Points on a scale (0-52) | MEAN |
| SECONDARY | HR-QoL Instrument and Domain Scores for the FACT-Th Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment | Baseline, Week 6, Week 14, and Week 26/Early Withdrawal | ITT Population | Points on a scale (0-24) | MEAN |
| SECONDARY | HR-QoL Instrument and Domain Scores From the MEI-SF Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment | Baseline, Week 6, Week 14, and Week 26/Early Withdrawal | ITT Population | Points on a scale (0-72) | MEAN |
Source ClinicalTrials.gov
Results by group236
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Responders | Placebo | Baseline | 2 | Percentage of participants | |
| Percentage of Responders | Eltrombopag 50 mg QD | Baseline | 1 | Percentage of participants | |
| Percentage of Responders | Placebo | Day 8 | 7 | Percentage of participants | |
| Percentage of Responders | Eltrombopag 50 mg QD | Day 8 | 37 | Percentage of participants | |
| Percentage of Responders | Placebo | Day 15 | 8 | Percentage of participants | |
| Percentage of Responders | Eltrombopag 50 mg QD | Day 15 | 46 | Percentage of participants | |
| Percentage of Responders | Placebo | Day 22 | 8 | Percentage of participants | |
| Percentage of Responders | Eltrombopag 50 mg QD | Day 22 | 51 | Percentage of participants | |
| Percentage of Responders | Placebo | Day 29 | 10 | Percentage of participants | |
| Percentage of Responders | Eltrombopag 50 mg QD | Day 29 | 49 | Percentage of participants |
1 to 10 of 236Source ClinicalTrials.gov
See all 236 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 62 | |
| Overall Study | STARTED | Eltrombopag 50 mg QD | 135 | |
| Overall Study | COMPLETED | Placebo | 55 | |
| Overall Study | COMPLETED | Eltrombopag 50 mg QD | 112 | |
| Overall Study | NOT COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Eltrombopag 50 mg QD | 23 |
Source ClinicalTrials.gov
Adverse events124
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 | Placebo | 12 | 61 | |
| other | Nasopharyngitis | Infections and infestations | Eltrombopag 50 mg QD | 14 | 135 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 7 | 61 | |
| other | Upper respiratory tract infection | Infections and infestations | Eltrombopag 50 mg QD | 14 | 135 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 4 | 61 | |
| other | Urinary tract infection | Infections and infestations | Eltrombopag 50 mg QD | 8 | 135 | |
| other | Influenza | Infections and infestations | Placebo | 3 | 61 | |
| other | Influenza | Infections and infestations | Eltrombopag 50 mg QD | 7 | 135 | |
| other | Pharyngitis | Infections and infestations | Placebo | 1 | 61 | |
| other | Pharyngitis | Infections and infestations | Eltrombopag 50 mg QD | 9 | 135 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Eltrombopag 50 mg QD | ||
| Total, other adverse events | Placebo | 56 | 61 |
| Total, other adverse events | Eltrombopag 50 mg QD | 120 | 135 |
| Total, serious adverse events | Placebo | 11 | 61 |
| Total, serious adverse events | Eltrombopag 50 mg QD | 16 | 135 |
Source ClinicalTrials.gov
Papers6
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Eltrombopag 50 mg QD vs Placebo: serious adverse events |
Source 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/NCT00370331
GET https://conductscience.org/api/trials/v1/NCT00370331/results?page=2