Phase 2
N=16
Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
Thrombocytopenic Purpura
Bottom Line
View on ClinicalTrials.gov: NCT00117143 ↗Enrolled (actual)
16
Serious AEs
25.0%
Results posted
Dec 2019
Primary outcome: Primary: Number of Participants With Adverse Events — 4; 4; 7; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Romiplostim (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Jul 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
4; 4; 7; 1; 0; 0 | — |
| PRIMARY Number of Participants With Positive Anti-Romiplostim Antibodies |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Achieved a Targeted Therapeutic Platelet Response |
1; 4; 4; 0; 1; 3 | — |
| SECONDARY Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L From Baseline |
2; 4; 5; 1; 1; 3 | — |
| SECONDARY Number of Participants With Peak Platelet Counts of ≥ 100 x 10⁹ Cells/L |
1; 3; 3; 1; 0; 1 | — |
| SECONDARY Number of Participants With Peak Platelet Counts of ≥ 450 x 10⁹ Cells/L |
0; 0; 1; 1; 0; 0 | — |
| SECONDARY Change From Baseline to Peak Platelet Level |
38.75; 89.98; 271.3; 1033.20; 11.50; 46.48 | — |
| SECONDARY Time to Peak Platelet Count |
10.5; 9.0; 12.0; 17.0; 13.5; 9.5 | — |
| SECONDARY Duration Within the Targeted Therapeutic Range |
10.0; 5.5; 8.0; 1.0; 2.0; 8.0 | — |
Summary
The purpose of this study is to assess the safety and tolerability of AMG 531 (romiplostim), a novel thrombopoiesis-stimulating peptibody, and its effect on platelet counts in adults with immune thrombocytopenic purpura.
Eligibility Criteria
Inclusion Criteria
- Greater than or equal to 3 months history of ITP, regardless of splenectomy status, and completion of at least 1 prior treatment for ITP
- 2 of 3 pretreatment platelet counts that were less than 30 x 10^9/L (if not currently on ITP therapy) or less than 50 x 10^9/L (if currently receiving corticosteroids for ITP therapy)
- Ability to give informed consent
Exclusion Criteria
- Known history of arterial thrombosis, active malignancy, or bone marrow stem cell disorder
Data sourced from ClinicalTrials.gov (NCT00117143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.