| June 30, 2005 |
| October 22, 2009 |
| August 2004 |
| December 2009 (final data collection date for primary outcome measure) |
| Incidence of adverse events, including clinically significant changes in laboratory values and incidence of antibody formation. [ Time Frame: Entire duration of the study ] [ Designated as safety issue: Yes ] |
| Incidence of adverse events, including clinically significant changes in laboratory values and incidence of antibody formation. |
| Complete list of historical versions of study NCT00116688 on ClinicalTrials.gov Archive Site |
- Duration platelet response [ Time Frame: Entire duration of the study ] [ Designated as safety issue: No ]
- The proportion of subjects able to reduce or discontinue their concurrent ITP therapies (corticosteroids, danazol, azathioprine) The change from baseline in patient reported outcomes (PRO) [ Time Frame: Entire duration of the study ] [ Designated as safety issue: No ]
|
- Duration platelet responce
- The proportion of subjects able to reduce or discontinue their concurrent ITP therapies (corticosteroids, danazol, azathioprine) The change from baseline in patient reported outcomes (PRO)
|
| |
| Open Label Extension Study of AMG 531 in Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) |
| An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) |
The purpose of this study is to determine the safety of AMG 531 as a long-term treatment in thrombocytopenic subjects with ITP, to evaluate the long-term platelet response to AMG 531, and to evaluate changes in patient reported outcomes due to the use of AMG 531. Subjects must have previously completed an AMG 531 ITP study. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
- Thrombocytopenia
- Idiopathic Thrombocytopenic Purpura
|
| Biological: AMG 531 |
| Experimental: Active investigational product |
- Kuter DJ, Mufti GJ, Bain BJ, Hasserjian RP, Davis W, Rutstein M. Evaluation of bone marrow reticulin formation in chronic immune thrombocytopenia patients treated with romiplostim. Blood. 2009 Oct 29;114(18):3748-56. Epub 2009 Aug 11.
- Bussel JB, Kuter DJ, Pullarkat V, Lyons RM, Guo M, Nichol JL. Safety and efficacy of long-term treatment with romiplostim in thrombocytopenic patients with chronic ITP. Blood. 2009 Mar 5;113(10):2161-71. Epub 2008 Nov 3.
|
| |
| Enrolling by invitation |
| 350 |
| December 2009 |
| December 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Subjects must have previously completed an AMG 531 ITP study
- Written informed consent
Exclusion Criteria:
- Bone marrow stem cell disorder or new active malignancies diagnosed since enrollment in the previous AMG 531 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 AMG 531 ITP study), or subject is receiving other investigational agent(s) other than AMG 531.
- Not using adequate contraceptive precautions
- Not available for follow-up assessments
- Has any kind of disorder that compromises the ability of the subject to give informed consent and does not have a legally-acceptable representative and/or is unable to comply with study procedures
|
| Both |
| 1 Year and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom |
| |
| NCT00116688 |
| Global Development Leader, Amgen Inc. |
| 20030213 |
| Amgen |
|
|
|
| Amgen |
| October 2009 |
