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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2022
• Main ID: NCT00102336
• Date of registration: 27/01/2005
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy
• Scientific title: A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy
• Date of first enrolment: April 7, 2005
• Target sample size: 62
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00102336
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of ITP according to American Society of Hematology (ASH) guidelines
(Appendix F)

- Have completed as least 1 prior treatment for ITP (e.g., prednisone)

- 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:

- Have had a Splenectomy for any reason

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Thrombocytopenia

Idiopathic Thrombocytopenic Purpura

Intervention(s)

Biological: AMG 531

Drug: Placebo

Primary Outcome(s)

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 [Time Frame: Last 8 weeks of treatments]

Secondary Outcome(s)

To evaluate possible reductions in the dose of concurrent ITP therapies while receiving AMG 531 [Time Frame: Entire duration of the study]

To evaluate the overall safety of AMG 531 [Time Frame: Entire duration of the study including the follow up period]

To evaluate changes in Patient Reported Outcomes (PRO) and Health Resource Utilization (HRU) due to treatment with AMG 531 [Time Frame: Entire duration of the study]

Secondary ID(s)

20030212

Source(s) of Monetary Support

Please refer to primary and secondary sponsors