A Three-part Study of Eltrombopag in Thrombocytopenic Subjects With Myelodysplastic Syndromes or Acute Myeloid Leukemia
Public ClinicalTrials.gov record NCT01440374. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Three-part Study of Eltrombopag in Thrombocytopenic Subjects With Myelodysplastic Syndromes or Acute Myeloid Leukemia (Part 1: Open-label, Part 2: Randomized, Double-blind, Part 3: Extension)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was a worldwide, three-part (Part 1: open-label, Part 2: randomized, double-blind, Part 3: extension), multi-center study to evaluate the effect of eltrombopag in subjects with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) who have thrombocytopenia due to bone marrow insufficiency from their underlying disease or prior chemotherapy. This objective was assessed by a composite primary endpoint that consists of the following: the proportion of ≥Grade 3 hemorrhagic adverse events, or platelet counts \<10 Gi/L, or platelet transfusions. Patients with MDS or AML and Grade 4 thrombocytopenia due to bone marrow insufficiency from their underlying disease or prior chemotherapy were enrolled in the study. No low or intermediate-1 risk MDS subjects were enrolled in the study. Subjects must have had at least one of the following during the 4 weeks prior to enrolment: platelet count \<10 Gi/L, platelet transfusion, or symptomatic hemorrhagic event. Supportive standard of care (SOC), including hydroxyurea, was allowed as indicated by local practice throughout the study. The study had 3 sequential parts. Subjects who were enrolled in Part 1 (open-label) cannot be enrolled in Part 2 of the study (randomized, double-blind); however, subjects who completed the treatment period for Part 1 or Part 2 (8 and 12 weeks, respectively) continued in Part 3 (extension) if the investigator determined that the subject was receiving clinical benefit on treatment.
Study identification
- NCT ID
- NCT01440374
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 162 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 110 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2011 (Type not available)
- Primary completion
- Mar 2015 (Actual)
- Completion
- Dec 2015 (Actual)
- Last update posted
- Jun 5, 2017
2011 – 2015
United States locations
- U.S. sites
- 18
- U.S. states
- 13
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Phoenix | Arizona | 85016 | — |
| Novartis Investigative Site | Hot Springs | Arkansas | 71913 | — |
| Novartis Investigative Site | Jonesboro | Arkansas | 72401 | — |
| Novartis Investigative Site | Los Angeles | California | 90095 | — |
| Novartis Investigative Site | Stanford | California | 94305 | — |
| Novartis Investigative Site | Jacksonville | Florida | 32256 | — |
| Novartis Investigative Site | Orlando | Florida | 32806 | — |
| Novartis Investigative Site | West Palm Beach | Florida | 33401 | — |
| Novartis Investigative Site | Augusta | Georgia | 30912 | — |
| Novartis Investigative Site | Baltimore | Maryland | 21201 | — |
| Novartis Investigative Site | Boston | Massachusetts | 02115 | — |
| Novartis Investigative Site | Kansas City | Missouri | 64128 | — |
| Novartis Investigative Site | Hackensack | New Jersey | 07601 | — |
| Novartis Investigative Site | Voorhees Township | New Jersey | 08043 | — |
| Novartis Investigative Site | The Bronx | New York | 10467 | — |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19140 | — |
| Novartis Investigative Site | Seattle | Washington | 98108 | — |
| Novartis Investigative Site | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 102 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01440374, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 5, 2017 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01440374 live on ClinicalTrials.gov.