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A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Patients With Immune (Idiopathic) Thrombocytopenia Purpura

NCT01071954 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-01-18

Study results available
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Summary

This is an extension study designed to assess the safety and durability of platelet count increases with romiplostim treatment of thrombocytopenic patients with immune (Idiopathic) thrombocytopenia purpura. This study is available to pediatric patients who have completed a previous romiplostim ITP study and meet the eligibility criteria of this study.

Conditions

  • Thrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITP

Interventions

BIOLOGICAL

Romiplostim

Administered by subcutaneous injection once a week.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-30
Primary Completion
2017-01-12
Completion
2017-01-12

Countries

  • United States
  • Australia
  • Canada
  • Spain

Study Locations

More Related Trials

Entities

Companies

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 NCT01071954 on ClinicalTrials.gov