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Extended Dosing With Eltrombopag for Severe Aplastic Anemia

NCT01891994 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-04-25

Study results available
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Summary

Background:

\- Eltrombopag is a drug being tested for treating severe aplastic anemia. It can help improve blood counts in these patients. However, researchers do not know how long the drug can and should be taken for this type of anemia.

Objectives:

\- To look at whether 6 months of treatment with eltrombopag can improve patient s blood counts.

Eligibility:

\- Individuals at least 2 years of age who are taking eltrombopag for severe aplastic anemia.

Design:

* Participants will take eltrombopag by mouth once a day for 6 months.
* Blood samples will be collected every 2 weeks for the first 6 months. Bone marrow samples will be collected at 3 and 6 months. These samples will look at the effects of the study drug on the marrow.
* Participants will continue to take the study drug for as long as it is effective and if the side effects are not severe.

Conditions

  • Severe Aplastic Anemia (SAA)

Interventions

DRUG

Eltrombopag

Oral administration of eltrombopag 150mg/day (75 mg/day for East Asian ancestry) for 6 months

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Cynthia E Dunbar, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-28
Primary Completion
2017-10-16
Completion
2022-08-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01891994 on ClinicalTrials.gov