Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura

NCT ID: NCT00415532

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-01
• Study Completion Date: 2009-05-11

Brief Summary

This is a phase 3b, multi-center, randomized, Standard of Care (SOC)-controlled, open-label, 52-week treatment study to compare romiplostim to medical SOC for Idiopathic Thrombocytopenia Purpura (ITP), with a 6-month Safety Follow-up. Patients randomized to romiplostim must complete the taper or discontinuation of medical SOC for ITP as soon as medically feasible after the initiation of romiplostim. After the completion or discontinuation of the study treatment period, any participant who does not transfer in to another romiplostim study will complete a 6-month Safety Follow-up period.

Conditions

Idiopathic Thrombocytopenic Purpura; Thrombocytopenia; Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP); Thrombocytopenic Purpura

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Romiplostim

Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10\^9/L for up to 52 weeks.

Group Type: EXPERIMENTAL

Romiplostim

Intervention Type: BIOLOGICAL

Standard of Care

Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.

Group Type: OTHER

Medical Standard of Care for ITP

Intervention Type: DRUG

Interventions

Medical Standard of Care for ITP

Intervention Type: DRUG

Romiplostim

Intervention Type: BIOLOGICAL

Other Intervention Names

AMG 531

Eligibility Criteria

Inclusion Criteria

• Subject is ≥ 18 years of age
• Subject has a diagnosis of Idiopathic Thrombocytopenia Purpura (ITP) according to the American Society of Hematology (ASH) guidelines
• If subject is > 60 years of age, subject has a written bone marrow biopsy report confirming the diagnosis of ITP
• Subject has received at least 1 prior therapy for ITP
• Subject has a platelet count < 50,000 or their platelet count falls to < 50,000 during or after a clinically-indicated taper or discontinuation of current ITP therapy
• Before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria

• Subject has had a splenectomy for any reason
• Subject has an active malignancy
• Subject has a history of cancer, other than basal cell carcinoma or cervical carcinoma in situ, with treatment or active disease within 5 years
• Subject has a known history of bone marrow stem cell disorder
• Subject has participated in any study evaluating polyethylene glycol-conjugated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), recombinant human thrombopoietin (rHuTPO), AMG 531, or a thrombopoietic protein
• Subject is receiving other investigational agents or procedures
• Subject is currently enrolled in, or has completed within the last 30 days, another investigational device or drug study
• Subject is pregnant or breast feeding
• Subject is not using adequate contraceptive precautions
• Subject has known sensitivity to any recombinant E. coli-derived product
• Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and does not have a legally acceptable representative
• Subject has any kind of disorder that compromises the ability of the subject to comply with study procedures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

Kuter DJ, Mathias SD, Rummel M, Mandanas R, Giagounidis AA, Wang X, Deuson RR. Health-related quality of life in nonsplenectomized immune thrombocytopenia patients receiving romiplostim or medical standard of care. Am J Hematol. 2012 May;87(5):558-61. doi: 10.1002/ajh.23163. Epub 2012 Mar 28.

Reference Type: BACKGROUND

PMID: 22460421 (View on PubMed)

Kuter DJ, Rummel M, Boccia R, Macik BG, Pabinger I, Selleslag D, Rodeghiero F, Chong BH, Wang X, Berger DP. Romiplostim or standard of care in patients with immune thrombocytopenia. N Engl J Med. 2010 Nov 11;363(20):1889-99. doi: 10.1056/NEJMoa1002625.

Reference Type: BACKGROUND

PMID: 21067381 (View on PubMed)

Related Links

http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf

Notice regarding posted summaries of trial results

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20060131

Identifier Type: -

Identifier Source: org_study_id