NCT01194167

Brief Summary

This phase II trial is studying the effects of the drug eltrombopag has on thrombocytopenia (low platelet count). Eltrombopag is approved by the FDA for the treatment of thrombocytopenia (low platelet count) in adults who have had an insufficient response to medications such as corticosteroids and immunoglobulins. Eltrombopag is not approved by the FDA (Food and Drug Administration) for the treatment of thrombocytopenia refractory to platelet transfusion and so for this study is considered investigational.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 2, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

November 25, 2019

Status Verified

January 1, 2012

Enrollment Period

1.4 years

First QC Date

August 25, 2010

Last Update Submit

November 21, 2019

Conditions

Thrombocytopenia

Keywords

Platelet refractory thrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • Determine the likelihood of eltrombopag allowing platelet transfusion independence in patients with platelet refractoriness at doses of 75 mg, 150 mg, and 300 mg per day

    3 years average

Study Arms (1)

Eltrombopag

EXPERIMENTAL

Eltrombopag 75 mg per day. Possible escalation to 150 mg per day after day 15 lab results. Possible escalation to 300 mg per day after day 29 lab results.

Drug: Eltrombopag

Interventions

EltrombopagDRUG

75 mg per day with possible dose escalation to 150 mg per day and 300 mg per day

Eltrombopag

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Laboratory diagnosis of platelet refractoriness
  • Diagnosis of platelet dependence
  • Adequate liver and renal laboratory screening tests

You may not qualify if:

  • Patients with thrombocytopenia that are responsive to platelet therapy
  • Patients actively receiving intravenous immunoglobulin, plasmapheresis or cytotoxic medications for thrombocytopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Thrombocytopenia

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Study Officials

  • Patricia Carey, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2010

First Posted

September 2, 2010

Study Start

August 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

November 25, 2019

Record last verified: 2012-01

Locations

US(1)