Trial · NCT01762761
Eltrombopag Phase III Study In Chinese Chronic ITP Patients
NCT01762761, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2015-03-09
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ConductScience Library. Eltrombopag Phase III Study In Chinese Chronic ITP Patients. Trials, record NCT01762761. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01762761
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Eltrombopag Phase III Study In Chinese Chronic ITP Patients
- NCT number
- NCT01762761
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 155 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Purpura, Thrombocytopenic, Idiopathic and Hepatitis C
- Interventions
- eltrombopag, placebo
- First posted
- 2013-01-08
- Last updated
- 2019-12-03
- Results first posted
- 2015-03-09
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants (Responders) Achieving a Platelet Count >=50×10^9/L After the First 6 Weeks of Stage 1 | From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1 | The number of participants (responders) with platelet count \>=50x10\^9/L after 6 weeks of Stage 1 were compared between treatments using a logistic regression model adjusted for use of primary immune thrombocytopenia (ITP) medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15×10\^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Primary Analysis Data Set: a participant who withdrawals from Stage 1 or is emergently unblinded was classified as a negative response from the time of withdrawal or unblinding date and for all subsequent visits. In the event of a participant dying, information for all subsequent assessments would be considered missing. All intermittent missing data (apart from withdrawals) will be treated as missing. |
| Secondary | Number of Participants Achieving a Platelet Count >=50×10^9/L at Least Once During the First 6 Weeks of Stage 1 | From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1 | The number of participants (responders) with platelet count \>=50×10\^9/L at least once during the first 6 weeks of Stage 1 were compared between treatments using a logistic regression model adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15×10\^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. |
| Secondary | Number of Participants Achieving a Platelet Count >=30×10^9/L and at Least 2 Times the Baseline Platelet Count at Least Once During the 6 Weeks of Stage 1, the Whole Stage 2 and the Whole Stage 3 | From the start of study treatment (Day 1) up to the end of Stage 3 | The number of participants achieving a platelet count \>=30×10\^9/L and at least 2 times the Baseline platelet count at least once during the first 6 weeks of Stage 1 were analyzed. The Baseline platelet count is defined as the platelet count taken on Day 1 of the study or within 48 hours prior to the first dose of investigational product. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15×10\^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. |
| Secondary | Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale | From the start of study treatment (Day 1) up to the end of Stage 3 | 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 blood loss, and grade 4 = debilitating blood loss. The WHO Bleeding Scale were dichotomized to indicate no bleeding vs bleeding, i.e. 0=grade 0 and 1=grades 1, 2, 3 or 4. Generalized linear mixed model was applied with a Logit canonical link function for repeated binary data, allowing for Baseline dichotomized WHO bleeding grade, use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15×10\^9/L (yes/no) and treatment as fixed effects, and the participant was treated as a random effect. Bleeding incidences were recorded at Screening, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6 for Stage 1, Baseline, Weeks 4, 8, 16, 20, 24 for Stage 2; Baseline, Weeks 25, 29, 73, 97, 121, 145, 169, 193, 217, 241, 265, 284 for Stage 3. Bleeding incidences at these time points are presented. |
| Secondary | Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale | From the start of study treatment (Day 1) up to the end of Stage 3 | 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 blood loss, and grade 4 = debilitating blood loss. The WHO Bleeding Scale grades were dichotomized into the following categories: no clinically significant bleeding = Grade 0 to 1; clinically significant bleeding = Grade 2 to 4. Generalized linear mixed model with a Logit canonical link function for repeated binary data, allowing for Baseline dichotomized WHO bleeding grade, use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15×10\^9/L (yes/no) and treatment as fixed effects, and the participant was treated as a random effect. |
| Secondary | Time to Response | From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1 | Time to response is defined as time from the startin of treatment to the first time of achieving a platelet count \>=50x10\^9/L during the first 6 weeks of Stage 1. Time to response is summarized using Kaplan-Meier estimates and compared between treatment groups using a stratified log-rank test, stratifying for the use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15x10\^9/L (yes/no). The pike estimator of the treatment hazard ratio is based on the stratified log-rank test. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. |
| Secondary | Number of Participants Who Required Protocol-defined Rescue Treatment During the First 6 Weeks of Stage 1, Whole Stages 2 & 3 | From the start of study treatment (Day 1) up to the end of Stage 3 | Rescue treatment is defined as either a new ITP medication, an increase in dose of concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15x10\^9/L (yes/no) and treatment. |
| Secondary | Number of Participants With a Platelet Count >=50×10^9/L During at Least 75% of Their Platelet Count Assessments | From the start of study treatment (Day 1) up to the end of Stage 3 | The number of participants with a platelet count \>=50×10\^9/L during at least 75% of their platelet count assessments was analyzed up to the end of Week 6 of Stage 1. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count \<=15x10\^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. |
| Secondary | Total Duration of Time a Participant Had a Platelet Count >=50×10^9/L | From the start of study treatment (Day 1) up to the end of Stage 3 | Total duration of time a participant had platelet count \>=50 x 10\^9/L was analyzed using the van Elteren stratified rank test with stratification factors including the use of ITP medication at Baseline (yes/no), splenectomy (yes/no) and Baseline platelet count \<=15x10\^9/L (yes/no). Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. |
| Secondary | Maximum Period of Time a Participant Had a Platelet Count Continuously >= 50 ×10^9/L | From the start of study treatment (Day 1) up to the end of Stage 3 | Maximum period of time a participant had a platelet count continously \>=50 x 10\^9/L was analyzed using the van Elteren stratified rank test with stratification factors including the use of ITP medication at Baseline (yes/no), splenectomy (yes/no) and Baseline platelet count \<=15x10\^9/L (yes/no). Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants (Responders) Achieving a Platelet Count >=50×10^9/L After the First 6 Weeks of Stage 1 | From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1 | Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication and with at least one platelet count post-Baseline in Stage 1. | Participants | NUMBER |
| SECONDARY | Number of Participants Achieving a Platelet Count >=50×10^9/L at Least Once During the First 6 Weeks of Stage 1 | From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1 | ITT Population: all randomized participants who received at least one dose of study medication and with at least one platelet count post-Baseline in Stage 1. | Participants | NUMBER |
| SECONDARY | Number of Participants Achieving a Platelet Count >=30×10^9/L and at Least 2 Times the Baseline Platelet Count at Least Once During the 6 Weeks of Stage 1, the Whole Stage 2 and the Whole Stage 3 | From the start of study treatment (Day 1) up to the end of Stage 3 | ITT Population: was comprised of all rand. participats who received at least 1 dose of study medication \& with at least 1 platelet count post-baseline (BL) in stages 1, 2 \& 3. 1 part. did not have a BL platelet count as platelet count not collected on Day 1 or within 48 hours prior to the 1st dose of investig. product; this part. was not evaluable | Participants | NUMBER |
| SECONDARY | Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale | From the start of study treatment (Day 1) up to the end of Stage 3 | ITT Population: was comprised of all rand. participats who received at least 1 dose of study medication \& with at least 1 platelet count post-baseline (BL) in stages 1, 2 \& 3. | Participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale | From the start of study treatment (Day 1) up to the end of Stage 3 | ITT Population: was comprised of all rand. participats who received at least 1 dose of study medication \& with at least 1 platelet count post-baseline (BL) in stages 1, 2 \& 3. | Participants | NUMBER |
| SECONDARY | Time to Response | From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1 | ITT Population: was comprised of all randomized participants who received at least 1 dose of study medication \& with at least 1 platelet count post-baseline in Stage 1. Only those participants with a response were analyzed. | Weeks | MEDIAN |
| SECONDARY | Number of Participants Who Required Protocol-defined Rescue Treatment During the First 6 Weeks of Stage 1, Whole Stages 2 & 3 | From the start of study treatment (Day 1) up to the end of Stage 3 | ITT Population: was comprised of all rand. participats who received at least 1 dose of study medication \& with at least 1 platelet count post-baseline (BL) in stages 1, 2 \& 3. | Participants | NUMBER |
| SECONDARY | Number of Participants With a Platelet Count >=50×10^9/L During at Least 75% of Their Platelet Count Assessments | From the start of study treatment (Day 1) up to the end of Stage 3 | ITT Population: was comprised of all rand. participants who received at least 1 dose of study medication \& with at least 1 platelet count post-baseline (BL) in stages 1, 2 \& 3. | Participants | NUMBER |
| SECONDARY | Total Duration of Time a Participant Had a Platelet Count >=50×10^9/L | From the start of study treatment (Day 1) up to the end of Stage 3 | ITT Population: was comprised of all rand. participants who received at least 1 dose of study medication \& with at least 1 platelet count post-baseline (BL) in stages 1, 2 \& 3. | Weeks | MEDIAN |
| SECONDARY | Maximum Period of Time a Participant Had a Platelet Count Continuously >= 50 ×10^9/L | From the start of study treatment (Day 1) up to the end of Stage 3 | ITT Population: was comprised of all rand. participants who received at least 1 dose of study medication \& with at least 1 platelet count post-baseline (BL) in stages 1, 2 \& 3. | Weeks | MEDIAN |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group374
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants (Responders) Achieving a Platelet Count >=50×10^9/L After the First 6 Weeks of Stage 1 | Placebo | 3 | Participants | ||
| Number of Participants (Responders) Achieving a Platelet Count >=50×10^9/L After the First 6 Weeks of Stage 1 | Eltrombopag | 60 | Participants | ||
| Number of Participants Achieving a Platelet Count >=50×10^9/L at Least Once During the First 6 Weeks of Stage 1 | Placebo | 9 | Participants | ||
| Number of Participants Achieving a Platelet Count >=50×10^9/L at Least Once During the First 6 Weeks of Stage 1 | Eltrombopag | 80 | Participants | ||
| Number of Participants Achieving a Platelet Count >=30×10^9/L and at Least 2 Times the Baseline Platelet Count at Least Once During the 6 Weeks of Stage 1, the Whole Stage 2 and the Whole Stage 3 | Placebo | Stage 1 (during the first 6 weeks) | 18 | Participants | |
| Number of Participants Achieving a Platelet Count >=30×10^9/L and at Least 2 Times the Baseline Platelet Count at Least Once During the 6 Weeks of Stage 1, the Whole Stage 2 and the Whole Stage 3 | Eltrombopag | Stage 1 (during the first 6 weeks) | 84 | Participants | |
| Number of Participants Achieving a Platelet Count >=30×10^9/L and at Least 2 Times the Baseline Platelet Count at Least Once During the 6 Weeks of Stage 1, the Whole Stage 2 and the Whole Stage 3 | Placebo | Stage 2 (during 24 weeks) | 45 | Participants | |
| Number of Participants Achieving a Platelet Count >=30×10^9/L and at Least 2 Times the Baseline Platelet Count at Least Once During the 6 Weeks of Stage 1, the Whole Stage 2 and the Whole Stage 3 | Eltrombopag | Stage 2 (during 24 weeks) | 81 | Participants | |
| Number of Participants Achieving a Platelet Count >=30×10^9/L and at Least 2 Times the Baseline Platelet Count at Least Once During the 6 Weeks of Stage 1, the Whole Stage 2 and the Whole Stage 3 | Placebo | Stage 3 | 36 | Participants | |
| Number of Participants Achieving a Platelet Count >=30×10^9/L and at Least 2 Times the Baseline Platelet Count at Least Once During the 6 Weeks of Stage 1, the Whole Stage 2 and the Whole Stage 3 | Eltrombopag | Stage 3 | 72 | Participants |
1 to 10 of 374Source ClinicalTrials.gov
See all 374 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 | 51 | |
| Overall Study | STARTED | Eltrombopag | 104 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | COMPLETED | Eltrombopag | 39 | |
| Overall Study | NOT COMPLETED | Placebo | 39 | |
| Overall Study | NOT COMPLETED | Eltrombopag | 65 |
Source ClinicalTrials.gov
Adverse events208
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 | ANAEMIA | Blood and lymphatic system disorders | Placebo | 9 | 51 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Eltrombopag | 17 | 104 | |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | Placebo | 2 | 51 | |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | Eltrombopag | 8 | 104 | |
| other | VISION BLURRED | Eye disorders | Placebo | 3 | 51 | |
| other | VISION BLURRED | Eye disorders | Eltrombopag | 7 | 104 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Placebo | 1 | 51 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Eltrombopag | 7 | 104 | |
| other | DIARRHOEA | Gastrointestinal disorders | Placebo | 8 | 51 | |
| other | DIARRHOEA | Gastrointestinal disorders | Eltrombopag | 11 | 104 |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 3 | 51 |
| Total, all-cause mortality | Eltrombopag | 0 | 104 |
| Total, other adverse events | Placebo | 48 | 51 |
| Total, other adverse events | Eltrombopag | 90 | 104 |
| Total, serious adverse events | Placebo | 17 | 51 |
| Total, serious adverse events | Eltrombopag | 33 | 104 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33251910 | DERIVED |
Source PubMed
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 |
|---|---|
| Eltrombopag vs Placebo: Number of Participants (Responders) Achieving a Platelet Count >=50×10^9/L After the First 6 Weeks of Stage 1 | Trial comparisons |
| Eltrombopag vs Placebo: Number of Participants Achieving a Platelet Count >=50×10^9/L at Least Once During the First 6 Weeks of Stage 1 | Trial comparisons |
| Eltrombopag vs Placebo: deaths from any cause | Trial comparisons |
| Eltrombopag vs Placebo: serious adverse events | 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/NCT01762761
GET https://conductscience.org/api/trials/v1/NCT01762761/registered?page=2