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P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
This study is currently recruiting participants.
Verified by Amgen, August 2008
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00603642
  Purpose

The purpose of this study is to evaluate the efficacy and safety of AMG 531 compared with placebo in thrombocytopenic Japanese subjects with immune (idiopathic) thrombocytopenic purpura (ITP) .


Condition Intervention Phase
Idiopathic Thrombocytopenic Purpura
Drug: Placebo
Drug: AMG 531
Phase III

Genetics Home Reference related topics: hemophilia thrombotic thrombocytopenic purpura
Drug Information available for: AMG 531
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double Blind, Placebo Controlled Phase 3 Study Evaluating the Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

Further study details as provided by Amgen:

Primary Outcome Measures:
  • The primary endpoint is number of weeks with weekly platelet responses. A weekly platelet response is defined as a platelet count of more than 50,000/mcL on a weekly scheduled dose day from week 2 to week 13. [ Time Frame: Until Dec 2008 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy: incidence of increase in platelet count more than 20,000/mcL from baseline [ Time Frame: Until Dec 2008 ] [ Designated as safety issue: Yes ]
  • Efficacy: change from baseline in mean of last 4 weekly platelet counts [ Time Frame: Until Dec 2008 ] [ Designated as safety issue: Yes ]
  • Safety: incidence of adverse events and evaluation of antibody status. [ Time Frame: Until Dec 2008 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: October 2007
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
AMG 531: Placebo Comparator
Double blinded placebo-controlled study
Drug: AMG 531
Subcutaneously administered, once a week, for 12 weeks
Placebo: Placebo Comparator Drug: Placebo
Subcutaneously administered, once a week, for 12 weeks

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Japanese patients with diagnosis of ITP according to the diagnostic criteria proposed by Research Committee for Idiopathic Hematopoietic Disorders of the Ministry of Health, Labour and Welfare [MHLW] (revised in 1990) at least 6 months before the first screening visit
  • The mean of the 3 scheduled platelet counts taken at the scheduled visits during the screening period must be ≤ 30 x 10^9/L, with no individual count > 35 x 10^9/L
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Subjects must be ≥ 20 years of age at the time of obtaining the informed consent
  • Have received at least 1 prior treatment for ITP
  • If known Helicobacter pylori positive, having completed one course of Helicobacter pylori eradication therapy at least 12 weeks before the first screening visit
  • A hemoglobin value taken at scheduled visit during the screening period must be ≥ 10 g/dL
  • A serum creatinine concentration taken at scheduled visit during the screening period must be ≤ 2 mg/dL
  • Adequate liver function, as evidenced by a total bilirubin taken at scheduled visit during the screening period ≤ 1.5 times of the upper limit of the normal range (except for patients with a confirmed diagnosis of Gilbert's Disease) or an alanine aminotransferase and aspartate aminotransferase taken at the screening visit ≤ 3 times of the upper limit of the normal range

Exclusion Criteria:

  • Any known history of bone marrow stem cell disorder. Any abnormal bone marrow findings other than those typical of ITP.
  • 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 the first screening visit.
  • Documented diagnosis of arterial thrombosis (eg, stroke, transient ischemic attack, or myocardial infarction); history of venous thrombosis (eg, deep vein thrombosis, pulmonary embolism) and receiving anticoagulation therapy at the first screening visit.
  • Documented diagnosis of anti phospholipid antibody syndrome
  • Currently receiving any treatment for ITP except oral corticosteroids, azathioprine and/or danazol administered at a constant dose and schedule from at least 4 weeks prior to the first screening visit
  • Received intravenous immunoglobulin, anti D immunoglobulin, or any drug administered to increase platelet counts (eg, immunosuppressants except azathioprine) within 2 weeks before the first screening visit
  • Have had a splenectomy for any reason within 12 weeks before the first screening visit
  • Past or present participation in any study evaluating pegacaristim (polyethylene glycol-conjugated recombinant human megakaryocyte growth and development factor, KRN9000), Eltrombopag (SB 497115), recombinant human thrombopoietin, AMG 531, or other Mpl stimulation product
  • Received hematopoietic growth factors (eg, granulocyte colony stimulating factor, macrophage colony stimulating factor, erythropoietin, interleukin 11) for any reason within 4 weeks before the first screening visit
  • Received any anti malignancy agents (eg, cyclophosphamide, 6 mercaptopurine, vincristine, vinblastine, Interferon alfa) for any reason within 8 weeks before the first screening visit
  • Received any monoclonal antibody drugs (eg, rituximab) for any reason within 14 weeks before the first screening visit
  • Less than 4 weeks since receipt of any therapeutic drug or device that is not MHLW approved for any indication before the first screening visit
  • Pregnant or breast feeding
  • Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
  • Known severe drug hypersensitivity
  • Concerns for subject's compliance with the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603642

Contacts
Contact: Amgen Call Center 866-572-6436

Locations
Japan
Research Site Recruiting
Hirakata, Japan
Research Site Recruiting
Chuo, Japan
Research Site Recruiting
Sagamihara, Japan
Research Site Recruiting
Tokyo, Japan
Research Site Recruiting
Isehara, Kanagawa, Japan
Research Site Recruiting
Sapporo, Hokkaido, Japan
Research Site Recruiting
Kumamoto, Japan
Research Site Recruiting
Hiroshima, Hiroshima, Japan
Research Site Recruiting
Suita, Osaka, Japan
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20060216
Study First Received: January 17, 2008
Last Updated: August 21, 2008
ClinicalTrials.gov Identifier: NCT00603642  
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Amgen:
AMG 531
Idiopathic Thrombocytopenic Purpura
ITP
Thrombocytopenia
Japan
Placebo controlled
Phase 3

Study placed in the following topic categories:
Purpura
Autoimmune Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemostatic Disorders
Purpura, Thrombocytopenic
Signs and Symptoms
Thrombocytopathy
Thrombocytopenia
Hemorrhagic Disorders
Thrombocytopenic purpura, autoimmune
Purpura, Thrombocytopenic, Idiopathic

Additional relevant MeSH terms:
Skin Manifestations
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009