Thrombocytopenic Purpura Clinical Trial
Official title:
An Open-label, Unit Dose-finding Study Evaluating the Safety and Efficacy of Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
Verified date | November 2019 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | July 19, 2004 |
Est. primary completion date | July 19, 2004 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Amgen |
Cines DB, Wasser J, Rodeghiero F, Chong BH, Steurer M, Provan D, Lyons R, Garcia-Chavez J, Carpenter N, Wang X, Eisen M. Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia. Haematologica. 2017 Aug;102(8):1342-1351. doi: 10.3324/haematol.2016.161968. Epub 2017 Apr 14. — View Citation
Newland A, Caulier MT, Kappers-Klunne M, Schipperus MR, Lefrere F, Zwaginga JJ, Christal J, Chen CF, Nichol JL. An open-label, unit dose-finding study of AMG 531, a novel thrombopoiesis-stimulating peptibody, in patients with immune thrombocytopenic purpura. Br J Haematol. 2006 Nov;135(4):547-53. doi: 10.1111/j.1365-2141.2006.06339.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Adverse Events | From first dose through 8 weeks after last dose of study drug (11 weeks) | ||
Primary | Number of Participants With Positive Anti-Romiplostim Antibodies | The presence or development of antibodies to romiplostim and endogenous thrombopoietin was assessed using a neutralizing bioassay. Antibody analyses were conducted on study days 29 and at the end-of-study visit (day 78). The number of participants with positive antibody binding at any time during the study is reported. | Days 29 and 78 | |
Secondary | Number of Participants Who Achieved a Targeted Therapeutic Platelet Response | Targeted therapeutic platelet response was defined as a (single) platelet count that was double the baseline level and between 50 and 450 × 10? cells/L.
Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders. |
Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants) | |
Secondary | Number of Participants With an Increase in Platelet Count of = 20 x 10? Cells/L From Baseline | Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders. | Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants) | |
Secondary | Number of Participants With Peak Platelet Counts of = 100 x 10? Cells/L | Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders. | After first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22), and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants) | |
Secondary | Number of Participants With Peak Platelet Counts of = 450 x 10? Cells/L | Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders. | After first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22), and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants) | |
Secondary | Change From Baseline to Peak Platelet Level | Platelet count data after the use of rescue medication were not included. | Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants) | |
Secondary | Time to Peak Platelet Count | Time from the date of study drug administration (day 1, 15 or 22) to the day of peak platelet count after each dose. Platelet count data after the use of rescue medication were not included. | From first dose of study drug to day 15 or 22, and from the second dose of study drug (day 15 or 22) to day 78 | |
Secondary | Duration Within the Targeted Therapeutic Range | Targeted therapeutic platelet level was defined as a platelet count that was double the baseline level and between 50 and 450 × 10? cells/L.
Platelet count data after the use of rescue medication were not included. |
From first dose of study drug to day 15 or 22, and from the second dose of study drug (day 15 or 22) to day 78 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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