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

NCT01974232 | Completed

• 1 other identifier: 1310014390
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Immune Thrombocytopenia

Keywords

Immune Thrombocytopenia (ITP), Thrombopoietin (TPO) agents, children, romiplostim and eltrombopag

Outcome Measures

Primary Outcomes (1)

• Platelet count greater than or = to 50,000

  on two consecutive weeks

Secondary Outcomes (1)

• An increase in platelets greater than or = to 20,000 over baseline.

  On two consecutive weeks

Other Outcomes (1)

• 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 ..

Study Arms (2)

Romiplostim group

Eltrombopag group

Eligibility Criteria

• Age: 19 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• \. Children who do not have ITP

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Children's Hospital of Orange County: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Jacobs syndrome

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• James B Bussel, M.D

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 1, 2013
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 1, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)