Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

NCT00117143 | Completed Phase 1 Results

• 1 other identifier: 20010218
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Thrombocytopenic Purpura

Keywords

Immune Thrombocytopenic Purpura; Idiopathic Thrombocytopenic Purpura; ITP; Thrombocytopenia

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events

  From first dose through 8 weeks after last dose of study drug (11 weeks)

• 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 Outcomes (7)

• Number of Participants Who Achieved a Targeted Therapeutic Platelet Response

  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)

• Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L From Baseline

  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)

• Number of Participants With Peak Platelet Counts of ≥ 100 x 10⁹ Cells/L

  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)

• Number of Participants With Peak Platelet Counts of ≥ 450 x 10⁹ Cells/L

  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)

• Change From Baseline to Peak Platelet Level

  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)

Study Arms (1)

Romiplostim

EXPERIMENTAL

Participants will receive a maximum of 2 administrations of romiplostim by subcutaneous injection, the first on day 1 of the study and the second on day 15 or 22 depending on the participant's platelet count. Romiplostim doses to be tested were 30, 100, 300, and 500 μg.

Drug: Romiplostim

Interventions

Romiplostim DRUG

Administered subcutaneously on day 1 and on day 15 or 22 if the platelet count was ≤ 50 x 10⁹/L and not rising, peak platelet count was ≤ 450 x 10⁹/L and no serious adverse events related to treatment were observed.

Also known as: AMG 531, NPLATE

Romiplostim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than or equal to 3 months history of ITP, regardless of splenectomy status, and completion of at least 1 prior treatment for ITP
• 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

You may not qualify if:

• Known history of arterial thrombosis, active malignancy, or bone marrow stem cell disorder

Sponsors & Collaborators

• Amgen: lead

Related 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.

  PMID: 28411254 BACKGROUND

• 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.

  PMID: 17061981 BACKGROUND

Related Links

• AmgenTrials clinical trials website
• FDA-approved Drug Labeling

MeSH Terms

Conditions

Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia

Interventions

romiplostim

Condition Hierarchy (Ancestors)

Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Blood Platelet Disorders; Cytopenia; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Hemorrhagic Disorders; Autoimmune Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 4, 2005
• Study Start: December 2, 2002
• Primary Completion: July 19, 2004
• Study Completion: July 19, 2004
• Last Updated: June 26, 2023
• Results First Posted: December 20, 2019

Record last verified: 2019-11