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Evaluating the Safety and Efficacy of AMG531 in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura(ITP)

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00111475
First received: May 20, 2005
Last updated: November 20, 2008
Last verified: November 2008
  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 Intervention Phase
Idiopathic Thrombocytopenic Purpura
Drug: AMG 531
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: A Dose-Finding Study Evaluating the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Incidence and severity of all adverse events and evaluation of antibody status

Secondary Outcome Measures:
  • Proportion of subjects who achieve a platelet level (a doubling of baseline 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)
  • Duration within the targeted therapeutic platelet range

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111475

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00111475     History of Changes
Other Study ID Numbers: 20000137
Study First Received: May 20, 2005
Last Updated: November 20, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Immune Thrombocytopenic Purpura
Idiopathic Thrombocytopenic Purpura
Thrombocytopenic
Thrombocytopenia
ITP

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Autoimmune Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Hemorrhage
Hemorrhagic Disorders
Immune System Diseases
Pathologic Processes
Signs and Symptoms
Skin Manifestations
Thrombocytopenia
Thrombotic Microangiopathies

ClinicalTrials.gov processed this record on November 25, 2014