Overview

This trial is active, not recruiting.

Condition immune thrombocytopenia (itp)
Treatment romiplostim
Phase phase 3
Sponsor Amgen
Start date December 2014
End date November 2019
Trial size 204 participants
Trial identifier NCT02279173, 20101221, 2011-005019-96

Summary

This is a phase 3b single arm, open label, multicenter study describing the percentage of time pediatric subjects with ITP have a platelet response while receiving romiplostim, defined as a platelet count ≥ 50 x 10^9/L and in the absence of ITP rescue medications in the past 4 weeks.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Romiplostim subcutaneous weekly injection
romiplostim
Romiplostim subcutaneous weekly injection

Primary Outcomes

Measure
The percentage of time with a platelet count of ≥ 50 x 10^9/L starting from week 2 in the first 6 months of the treatment period without rescue medication use in the past 4 weeks
time frame: 6 Months

Secondary Outcomes

Measure
The percentage of time with a platelet count of ≥ 50 x 10^9/L starting from week 2 until the end of the treatment period without rescue medication use in the past 4 weeks
time frame: 36 months
The percentage of time with an increase in platelet count ≥ 20 x10^9/L above baseline starting from week 2 until the end of the treatment period without rescue medication use within the past 4 weeks.
time frame: 36 months
Subject incidence of rescue ITP medications used
time frame: 36 months
The incidence of anti-romiplostim neutralizing antibodies and cross-reactive antibodies to thrombopoietin (TPO) at any time during the study
time frame: 38 months
The incidence of adverse events, including clinically significant changes in laboratory values
time frame: 38 months

Eligibility Criteria

Male or female participants from 1 year up to 18 years old.

Inclusion Criteria

    Exclusion Criteria

      Additional Information

      Official title A Single Arm, Open-label, Long-term Efficacy and Safety Study of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune Thrombocytopenia (ITP)
      Description This is a phase 3b single arm, open label, multicenter study describing the percentage of time pediatric subjects with ITP have a platelet response while receiving romiplostim, defined as a platelet count ≥ 50 x 10^9/L and in the absence of ITP rescue medications in the past 4 weeks. This protocol will provide open label romiplostim to thrombocytopenic pediatric subjects with ITP diagnosed for at least 6 months and who have received at least 1 prior ITP therapy (excluding romiplostim) or are ineligible for other ITP therapies.
      Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
      Information provided to ClinicalTrials.gov by Amgen.