A Retrospective Chart Review of Thirty Three Children Who Have Received Clinical Treatment With Either Romiplostim or Eltrombopag From 2009-2013

January 30, 2017 updated by: Weill Medical College of Cornell University
This is a retrospective analysis of children (≤21years old) who received clinical treatment with either Romiplostim or Eltrombopag at 2 medical centers from 2009-2013. The children included in this study were from Weill Medical College of Cornell University, New York, New York and Children's Hospital Orange County, Orange, California

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients eligible for this study included both males and females ≤ 21 years old (actual range 19 months - 19 years) with persistent/chronic ITP lasting >6 months and were diagnosed according to the clinical practice guidelines from the American Society of Hematology.

Description

Inclusion Criteria:

1. All patients in this study had received prior treatments before the start of TPO treatment including corticosteroids, IVIG, IV anti-D, and/or Rituximab.

Exclusion Criteria:

1. Children who do not have ITP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Romiplostim group
Eltrombopag group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Platelet count greater than or = to 50,000
Time Frame: on two consecutive weeks
on two consecutive weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
An increase in platelets greater than or = to 20,000 over baseline.
Time Frame: On two consecutive weeks
On two consecutive weeks

Other Outcome Measures

Outcome Measure
Time Frame
Percentage of weeks with platelet counts greater than or = to 50,000 independent of rescue therapy.
Time Frame: For Rescue therapy is defined as receiving Intravenous Immunoglobulin (IVIG) increased dose steroids or platelet transfusions . When given this resulted in exclusion of platelet counts for 2 full weeks after indication of rescue therapy ..
For Rescue therapy is defined as receiving Intravenous Immunoglobulin (IVIG) increased dose steroids or platelet transfusions . When given this resulted in exclusion of platelet counts for 2 full weeks after indication of rescue therapy ..

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Children's Hospital of Orange County

Investigators

  • Principal Investigator: James B Bussel, M.D, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

October 25, 2013

First Submitted That Met QC Criteria

October 25, 2013

First Posted (Estimate)

November 1, 2013

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1310014390

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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