Overview

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

Status:
Completed
Trial end date:
2007-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Criteria
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