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Study Complete
Sponsor ID
20090340

A study evaluating the safety and efficacy of long-term dosing of romiplostim in thrombocytopenic pediatric patients with immune (idiopathic) thrombocytopenia purpura

Sponsor ID
20090340
Clinicaltrials.gov ID
NCT01071954
EUCTIS ID
N/A
EudraCT ID
2009-016203-32
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
romiplostim
Type
Interventional
Masking
None (Open Label)
Enrollment
66
Additional Study Details

Protocol Summary

Primary Outcome Measures

the subject incidence and exposure adjusted incidence of adverse events, including clinically significant changes in laboratory values and incidence of antibody formation.

Timeframe: 5 years

Secondary Outcome Measures

Platelet response to romiplostim defined as platelet counts 50x109/L in the absence of rescue medication.

Timeframe: 5 years

The prevalence of concurrent ITP therapy use over time (corticosteroids, danazol, azathioprine, etc.).

Timeframe: 5 years

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
New York, NY, United States, 10021
Status
Recruiting
Location
Research Site
Dallas, TX, United States, 75390
Status
Recruiting
Location
Research Site
Orange, CA, United States, 92868
Status
Recruiting
Location
Research Site
Nashville, TN, United States, 37232
Status
Recruiting
Location
Research Site
Omaha, NE, United States, 68114
Status
Recruiting
Location
Research Site
South Brisbane, QLD, Australia, 4101
Status
Recruiting
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Study Info
Age
1+ years
Condition
  • Thrombocytopenia
    • Sex
    All
    Trial Dates
    Dec 2009 - Jan 2017
    Inclusion and Exclusion Criteria
    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.