Idiopathic Thrombocytopenia Purpura |
ITP |
Clinical Trial: Evaluating the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects with Immune Thrombocytopenic Purpura (ITP)
This study has been completed.
|
Purpose
The purposes of this study are: to determine a weekly dose that demonstrates a satisfactory safety profile and sustains elevated platelet counts within a targeted therapeutic level (a doubling of baseline platelet counts and within the range of greater than or equal to 50 x 10^9/L and less than or equal to 450 x 10^9/L in thrombocytopenic subjects with ITP; to assess Amgen megakaryopoiesis protein 2 [AMP2 (AMG 531)] pharmacokinetics (PK) in thrombocytopenic subjects with ITP.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Idiopathic Thrombocytopenic Purpura | Drug: AMG 531 | Phase II |
MedlinePlus related topics: Autoimmune Diseases; Bleeding Disorders; Blood and Blood Disorders; Immune System and Disorders
Study Type: Interventional
Study Design: Treatment, Safety/Efficacy Study
Official Title: A Dose-finding Study Evaluating the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects with Immune Thrombocytopenic Purpura (ITP)
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Diagnosis of ITP according to American Society of Hematology (ASH) guidelines at least 3 months before enrollment
- Have completed at least 1 prior treatment for ITP
- The mean of the 2 platelet 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, with no count greater than 55 x 10^9/L
- Hemoglobin greater than 10.0 g/dL
- Written informed consent
Exclusion Criteria:
- Any known history of bone marrow stem cell disorder
- 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
- Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure [New York Heart Association (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; *hypercholesteremia (greater than 240 mg/dL); *treatment for hypertension
- Known positive test for human immunodeficiency virus (HIV) infection or hepatitis C virus
- Received any treatment for ITP (except for a constant dose schedule of corticosteroids) within 4 weeks before the screening visit
- Received IVIg or WinRho within 2 weeks before the screening visit
- Received hematopoietic growth factors, including IL-11 (Neumega®) within 4 weeks before the screening visit
- Past or present participation in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO) or related platelet product
- Received any alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study
- Received any monoclonal antibody (eg, rituximab) within 16 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 2 months since major surgery (including laparoscopic splenectomy)
- Pregnant or breast feeding
- Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
More Information
AmgenTrials clinical trials website
CenterWatch Clinical Trials Listing Service
Record last reviewed: May 2005
Last Updated: May 20, 2005
Record first received: May 20, 2005
ClinicalTrials.gov Identifier: NCT00111475
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-24

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