An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP
This protocol will provide open label romiplostim to adult thrombocytopenic subjects. Romiplostim will be administered by subcutaneous injection once per week. Dose adjustment will be based on platelet counts, and will be allowed throughout the duration of the study. Rescue therapies are allowed at any time during the study. Reductions in concurrent ITP therapies may occur at any time when platelet counts are > 50,000.
Idiopathic Thrombocytopenic Purpura
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)|
- Adverse Events [ Time Frame: Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks. ] [ Designated as safety issue: Yes ]One or more occurences of one or more adverse events within the participant during the study. Participants with more than one event were only counted once
- Platelet Response (Definition 1) [ Time Frame: Duration of treatment (up to 201 weeks) ] [ Designated as safety issue: No ]Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of >=50 x 10^9/L
- Platelet Response (Definition 2) [ Time Frame: Duration of treatment (up to 201 weeks) ] [ Designated as safety issue: No ]Platelet response using definition 2 (a platelet count increase of >=20 x 109/L from baseline)
|Study Start Date:||February 2005|
|Study Completion Date:||March 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Romiplostim will be administered subcutaneously QW. Romiplostim will be manufactured and packaged and distributed using Amgen's clinical study investigational product distribution procedures. Romiplostim is presented as a lyophilized, white powder in 5.0 mL glass vials.
Other Name: romiplostim