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

Immune Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974232
• Other study ID #: 1310014390
• Status: Completed
• Phase: N/A
• First received: October 25, 2013
• Last updated: January 30, 2017
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2017
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Months to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Children’s Hospital of Orange County

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of weeks with platelet counts greater than or = to 50,000 independent 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 ..
Primary	Platelet count greater than or = to 50,000		on two consecutive weeks
Secondary	An increase in platelets greater than or = to 20,000 over baseline.		On two consecutive weeks