AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy

Thrombocytopenia Clinical Trial

Official title:

A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102323
• Other study ID #: 20030105
• Status: Completed
• Phase: Phase 3
• Start date: March 29, 2005
• Est. completion date: March 1, 2007

Study information

• Verified date: November 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by the platelet response. This study will also evaluate changes in Patient Reported Outcomes and Health Resource Utilization due to treatment with AMG 531.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 1, 2007
• Est. primary completion date: September 1, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of ITP according to American Society of Hematology (ASH) guidelines (Appendix F)
• Have had a splenectomy for the treatment of ITP greater than or equal to 24 weeks prior to study entry
• Subjects greater than 60 years of age must have a documented history of chronic ITP with a bone marrow report to confirm the diagnosis
• The platelet count (calculated from the mean of the 2 counts taken during the

screening and pre-treatment periods) must be:

• * less than 30 x 10^9/L for those subjects not receiving any ITP therapy, with no count greater than 35 x 10^9/L,
• * less than 50 x 10^9/L for those subjects receiving a constant dose schedule of corticosteroids, azathioprine or danazol with no count greater than 55 x 10^9/L
• A serum creatinine concentration less than or equal to 2 mg/dl(less than or equal to 176.8 µmol/L)
• Adequate liver function, as evidenced by a serum bilirubin less than or equal to 1.5 times the laboratory normal range
• Hemoglobin greater than 11.0 g/dL
• Written informed consent (see Section 12.1)

Exclusion Criteria:

• Any known history of bone marrow stem cell disorder (Any abnormal bone marrow findings other than those typical of ITP must be approved by Amgen before a subject may be enrolled in the study)
• Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years before randomization
• Documented diagnosis of arterial thrombosis (i.e., stroke, transient ischemic attack or myocardial infarction) in the past year
• History of venous thrombosis (i.e., deep vein thrombosis, pulmonary embolism) including those subjects who are on ant-coagulation therapy
• Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure [NYHA greater than class II], uncontrolled hypertension [diastolic greater than 100 mmHg] or cardiac arrhythmia)
• Have 3 or more of the following predisposing factors for thromboembolic events:

diabetes; smoker; using oral contraceptives; on estrogen therapy; known positive for anti-phospholipid antibodies; hypertriglyceridemia; hypercholesteremia (greater than 240 mg/dL); treatment for hypertension

• Known positive test for human immunodeficiency virus (HIV) infection or hepatitis C virus
• Currently receiving any treatment for ITP except corticosteroids, azathioprine or danazol administered at a constant dose and schedule
• IV Ig or anti-D Ig within 2 weeks before the screening visit
• Rituximab (for any indication) within 14 weeks before the screening visit or anticipated use during the time of the proposed study
• Received hematopoietic growth factors, including IL-11 (oprelvekin) within 4 weeks before the screening visit
• Past or present participation in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), AMG 531 or related platelet product
• Received any aklylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study
• Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA approved for any indication before the screening period
• Less than 8 weeks since major surgery
• Pregnant or breast feeding
• Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
• Known hypersensitivity to any recombinant E coli-derived product
• Concerns for subject's compliance with the protocol

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• Placebo
Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. Placebo is supplied as a lyophilized power in a 5 mL single use glass vial.

Biological:
• AMG 531
Weekly subcutaneous dosing based on screening weight and platelet count. Starting dose is at 1mcg/kg up to a maximum dose of 15mcg/kg. AMG 531 is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (3)

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

Kuter DJ, Arnold DM, Rodeghiero F, Janssens A, Selleslag D, Bird R, Newland A, Mayer J, Wang K, Olie R. Safety and efficacy of self-administered romiplostim in patients with immune thrombocytopenia: Results of an integrated database of five clinical trials. Am J Hematol. 2020 Jun;95(6):643-651. doi: 10.1002/ajh.25776. Epub 2020 Mar 21. — View Citation

Kuter DJ, Newland A, Chong BH, Rodeghiero F, Romero MT, Pabinger I, Chen Y, Wang K, Mehta B, Eisen M. Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia (ITP) for up to 1 year and in those with chronic ITP for more than 1 year: a subgroup analysis of integrated data from completed romiplostim studies. Br J Haematol. 2019 May;185(3):503-513. doi: 10.1111/bjh.15803. Epub 2019 Feb 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by durable platelet response during the last 8 weeks of treatment and other platelet response parameters		Last 8 weeks of treatment
Secondary	To evaluate the overall safety of AMG 531		Entire study duration plus follow up period
Secondary	To evaluate the possible reductions in concurrent ITP therapies while receiving AMG 531		Entire study duration
Secondary	To evaluate changes in Patient Reported Outcomes and Health Resource Utilization due to treatment with AMG 531		Entire study duration

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling
•   Notice regarding posted summaries of trial results
•   To access clinical trial results information click on this link