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



Status:Completed
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:1 - Any
Updated:1/31/2019
Start Date:December 30, 2009
End Date:January 12, 2017

Use our guide to learn which trials are right for you!

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 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.


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.
We found this trial at
25
sites
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Brunswick, New Jersey 08901
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
?
mi
from
Peoria, IL
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Randwick,
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials