Amgen Protocol:20090340 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 open-label extension study designed to determine the safety and durability of platelet count increases with romiplostim treatment of patients with ITP. The study will consist of a screening visit, a treatment period, and an end of study visit. Subjects are eligible based on previous participation in a romiplostim trial (IRB# 122007 052).
Participation involves 1 subcutaneous (under the skin) injection of romiplostim each week for the duration of the study. Platelet counts will be performed in the hospital clinic every 4 weeks to assess efficacy of the investigational product. About 1 ml is needed at each of the 4 week interval visits with an additional 4 teaspoons every 12 weeks for chemistry and antibody testing. All subjects who enter the extension study directly from a previous romiplostim study will enter the study on the same weekly dose received in the previous study. Subjects may continue to give self-injections and only come to clinic at the times needed for the blood work and after dose adjustments are made. These visits will last about 2 hours each. Each subject and amp;apos;s dose will be adjusted based on platelet counts and body weight taken every 12 weeks.
1.Previous participation in and completion of a romiplostim ITP study and written informed consent are required.
Inclusion criteria previously included
a)diagnosis of ITP according to The American Society of Hematology Guidelines,
b)diagnosis of ITP for at least 6 months,
c)adequate kidney and liver function and hemoglobin greater that 10.0 g/dL.
2.Subjects must be less than 18 years of age at enrollment.
Spanish speaking subjects are also eligible and will have short form consents available in Spanish. Males and females are eligible.