Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Amgen

Status and phase

Completed

Phase 3

Conditions

Thrombocytopenia

Idiopathic Thrombocytopenic Purpura

Treatments

Biological: Romiplostim

Study type

Interventional

Funder types

Industry

Identifiers

NCT00116688

20030213

Details and patient eligibility

About

The purpose of this study is to determine the safety of romiplostim as a long-term treatment in thrombocytopenic subjects with ITP, to evaluate the long-term platelet response to romiplostim, and to evaluate changes in patient reported outcomes due to the use of romiplostim. Participants must have previously completed a romiplostim ITP study.

Enrollment

313 patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must have previously completed a romiplostim ITP study
Platelet count ≤ 50 x 10 ^9/L
Written informed consent

Exclusion criteria

Bone marrow stem cell disorder or new active malignancies diagnosed since enrollment in the previous romiplostim ITP study
Received any alkylating agents within 4 weeks before screening visit or anticipated use during the time of the proposed study
Currently enrolled in or has not yet completed at least 4 weeks since ending device or drug trial(s) (other than the previous romiplostim ITP study), or subject is receiving other investigational agent(s) other than romiplostim
Not using adequate contraceptive precautions
Not available for follow-up assessments
Has any kind of disorder that compromises the ability of the participant to give informed consent and does not have a legally-acceptable representative and/or is unable to comply with study procedures.