GoldBamboo.com - Knowledge is strong medicine
  

Evaluating the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects with Immune Thrombocytopenic Purpura (ITP) - Article


  Not Signed In - Sign In / Register






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.

Sponsored by: Amgen
Information provided by: Amgen

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

Study ID Numbers:  20000137
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


Take control over your directory listings...INSTANTLY

Every day, thousands of users find businesses like yours in the GoldBamboo directory.

Limited Time Offer!!!

For only $50 a year, a savings of 50% off our standard rate:

  • Edit your listing (whenever you want!)
  • Link to your website
  • Choose which categories you are listed in
  • Describe your services

The process will take only a few minutes and consists of 3 easy steps:

1. Register     >     2. Edit Listings     >     3. Publish

Your Company
your street
yourtown, YS 12345
888-888-8888



No Thanks

Popular Treatments

Acne Treatment ADHD Treatment Allergy Treatment Alzheimer's Treatment
Anemia Treatment Arthritis Treatment Asthma Treatment Bipolar Disorder Treatment
Bird Flu Treatment Bladder Cancer Treatment Bladder Control Treatment Blood Pressure Treatment
Brain Tumor Treatment Breast Cancer Treatment Bronchitis Treatment Cancer Treatment
Cancer Alternative Treatment Cataract Treatment Cirrhosis Treatment Colitis Treatment
Colon Cancer Treatment Common Cold Treatment Conjunctivitis Treatment Constipation Treatment
Crohn's Disease Treatment Cystic Fibrosis Treatment Depression Treatment Dermatitis Treatment
Diabetes Treatment Edema Treatment Epilepsy Treatment Erectile Dysfunction Treatment
Fibromyalgia Treatment GERD Treatment Glaucoma Treatment Gout Treatment
Hay Fever Treatment Headache Treatment Heart Disease Treatment Hepatitis Treatment
High Blood Pressure Treatment High Cholesterol Treatment Hives Treatment Hypertension Treatment
Hypoglycemia Treatment IBS Treatment Impotence Treatment Indigestion Treatment
Infertility Treatment Influenza Treatment Insomnia Treatment Lactose Intolerance Treatment
Leukemia Treatment Lung Cancer Treatment Lyme Disease Treatment Macular Degeneration Treatment
Menopause Treatment Migraine Treatment Osteoarthritis Treatment Osteoporosis Treatment
Pancreatic Cancer Treatment PMS Treatment Pneumonia Treatment Prostate Diseases Treatment
Restless Leg Treatment Rheumatoid Arthritis Treatment Sepsis Treatment Sinusitis Treatment
Skin Cancer Treatment Sleep Apnea Treatment Snoring Treatment Stroke Treatment
Testicular Cancer Treatment
GoldBambooTM

Your Integrative Health and Wellness Resource for Idiopathic Thrombocytopenia Purpura.

October 12, 2008



Page Updated: September 6, 2005
Disclaimer: All material displayed on the GoldBamboo.com website is provided for educational purposes only. Consult a physician regarding the applicability of any information found on GoldBamboo.com to your symptoms or medical condition.

Massachusetts Law | Home | About Us | Link To Us | Feedback | Disclaimer | Privacy Policy | Terms of Use | Google Co-op | Health Forums

Copyright © 2004-2008 - Gold Bamboo LLC
All rights reserved.

HONcode accreditation seal.

We comply with the HONcode standard for health trust worthy information:
verify here.