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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01071954
First received: December 17, 2009
Last updated: October 15, 2014
Last verified: October 2014

December 17, 2009
October 15, 2014
December 2009
December 2016   (final data collection date for primary outcome measure)
the subject incidence and exposure adjusted incidence of adverse events, including clinically significant changes in laboratory values and incidence of antibody formation. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
the subject incidence and exposure adjusted incidence of adverse events, including clinically significant changes in laboratory values and incidence of antibody formation. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01071954 on ClinicalTrials.gov Archive Site
  • Platelet response to romiplostim defined as platelet counts 50x109/L in the absence of rescue medication. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • The prevalence of concurrent ITP therapy use over time (corticosteroids, danazol, azathioprine, etc.). [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Platelet response to romiplostim defined as platelet counts 50x109/L in the absence of rescue medication. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • The prevalence of concurrent ITP therapy use over time (corticosteroids, danazol, or azathioprine). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune (Idiopathic) Thrombocytopenia Purpura
An Open Label Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune (Idiopathic) Thrombocytopenia Purpura (ITP)

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Biological: Romiplostim

Starting Dose of 1µg/kg romiplostim or previous dose administered weekly

Individual Subject Dose Adjustment to a Maximum Dose of 10 µg/kg based on platelet count

Rescue Medications Allowed at Discretion of Investigator

Reduction in Concurrent ITP Therapies May Occur when Platelet Count is >50 x 109/L

Single Arm
Starting Dose of 1µg/kg romiplostim or previous dose administered weekly Individual Subject Dose Adjustment to a Maximum Dose of 10 µg/kg based on platelet count
Intervention: Biological: Romiplostim
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2017
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject or subject's legally acceptable representative has provided informed consent.
  • Subject completed a romiplostim study for the treatment of thrombocytopenia in pediatric subjects with ITP.

Exclusion Criteria:

  • Subject has or previously had any bone marrow stem cell disorder (any abnormal bone marrow findings other than those typical of ITP must be approved by Amgen before a subject may be enrolled in the study).
  • Subject has any new active malignancy diagnosed since enrollment in the previous romiplostim ITP study.
  • Subject received any alkylating agents within four weeks before the screening visit or anticipated use during the time of the proposed study.
  • Other investigational medications are excluded.
  • Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) (with the exception of romiplostim in a previous clinical study).
  • Female subject of child bearing potential (defined as having first menses) is not willing to use highly effective contraception during treatment and for 4 weeks after the end of treatment.
  • Female subject is pregnant or breast feeding, or planning to become pregnant within 4 weeks after the end of treatment.
  • Subject has known sensitivity to any of the products to be administered during dosing.
  • Subject previously has entered this study (this will depend on the type of study).
  • Subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge.
  • Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
Both
1 Year and older
No
Contact: Amgen Call Center 866-572-6436
United States,   Australia,   Canada,   Spain
 
NCT01071954
20090340
No
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP