Trial · NCT01891994
Extended Dosing With Eltrombopag for Severe Aplastic Anemia
NCT01891994, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2018-12-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extended Dosing With Eltrombopag for Severe Aplastic Anemia. Trials, record NCT01891994. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01891994
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extended Dosing With Eltrombopag for Severe Aplastic Anemia
- NCT number
- NCT01891994
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Severe Aplastic Anemia (SAA)
- Interventions
- Eltrombopag
- First posted
- 2013-07-03
- Last updated
- 2023-04-25
- Results first posted
- 2018-12-04
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Drug Response as Defined by Clinically-signficant Hematologic Improvements | 24 weeks | Defined as unilineage or multilineage recovery by 1 or more of the following: 1) platelet response (increase to 20 × 103/μL above baseline or stable platelet counts with transfusion independence for a minimum of 8 weeks in those who were transfusion dependent on entry into the protocol); (2) erythroid response (when pretreatment hemoglobin was \<9 g/dL, defined as an increase in hemoglobin by 1.5 g/dL or, in transfused patients, a reduction in the units of packed red blood cell transfusions by an absolute number of at least 4 transfusions for 8 consecutive weeks, compared with the pretreatment transfusion number in the previous 8 weeks); and (3) neutrophil response (when pretreatment absolute neutrophil count \[ANC\] of \<0.5 × 103/μL as at least a 100% increase in ANC, or an ANC increase \>0.5 × 103/μL, and the toxicity profile as measured using Common Terminology Criteria for Adverse Events). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Drug Response as Defined by Clinically-signficant Hematologic Improvements | 24 weeks | All subjects who received Eltrombopag were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Drug Response as Defined by Clinically-signficant Hematologic Improvements | Eltrombopag | 20 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eltrombopag | 40 | |
| Overall Study | COMPLETED | Eltrombopag | 40 | |
| Overall Study | NOT COMPLETED | Eltrombopag | 0 |
Source ClinicalTrials.gov
Adverse events207
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 | Acute Myeloid Leukaemia | Blood and lymphatic system disorders | Eltrombopag | 1 | 40 | |
| other | Anaemia | Blood and lymphatic system disorders | Eltrombopag | 16 | 40 | |
| other | Conjunctival pallor | Blood and lymphatic system disorders | Eltrombopag | 1 | 40 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Eltrombopag | 3 | 40 | |
| other | Ocular icterus | Blood and lymphatic system disorders | Eltrombopag | 10 | 40 | |
| other | Petechiae | Blood and lymphatic system disorders | Eltrombopag | 9 | 40 | |
| other | Purpura | Blood and lymphatic system disorders | Eltrombopag | 1 | 40 | |
| other | Atrial fibrillation | Cardiac disorders | Eltrombopag | 2 | 40 | |
| other | Dizziness | Cardiac disorders | Eltrombopag | 8 | 40 | |
| other | Dyspnoea | Cardiac disorders | Eltrombopag | 8 | 40 |
1 to 10 of 207Source ClinicalTrials.gov
See all 207 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eltrombopag | 1 | 40 |
| Total, other adverse events | Eltrombopag | 39 | 40 |
| Total, serious adverse events | Eltrombopag | 13 | 40 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01891994
GET https://conductscience.org/api/trials/v1/NCT01891994/events?page=2