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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00117143
Other study ID # 20010218
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date December 2, 2002
Est. completion date July 19, 2004

Study information

Verified date November 2019
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Romiplostim
Administered subcutaneously on day 1 and on day 15 or 22 if the platelet count was = 50 x 10?/L and not rising, peak platelet count was = 450 x 10?/L and no serious adverse events related to treatment were observed.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Amgen

References & Publications (2)

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

Outcome

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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03244410 - Lymphocyte Counts in Immune Thrombocytopenic Purpura N/A
Completed NCT00454857 - Retrospective & Prospective Observational Study of Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) N/A
Completed NCT01444417 - Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients Phase 3
Completed NCT00508820 - An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP Phase 3
Completed NCT00415532 - Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura Phase 3