P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00603642
First received: January 17, 2008
Last updated: February 4, 2011
Last verified: February 2011

January 17, 2008
February 4, 2011
October 2007
March 2009   (final data collection date for primary outcome measure)
Weeks With Weekly Platelet Response [ Time Frame: 12 weeks (Weeks 2 - 13) ] [ Designated as safety issue: No ]
Number of weeks with weekly platelet response. A weekly platelet response is defined as a platelet count of ≥ 50 x 10^9/L on a weekly scheduled dose day from week 2 to week 13.
The primary endpoint is number of weeks with weekly platelet responses. A weekly platelet response is defined as a platelet count of ≥ 50 x 10^9/L on a weekly scheduled dose day from week 2 to week 13.
Complete list of historical versions of study NCT00603642 on ClinicalTrials.gov Archive Site
  • Increased Platelet Count From Baseline of at Least 20 x 10^9/L [ Time Frame: Baseline, 12 weeks (Weeks 2 - 13) ] [ Designated as safety issue: No ]
    An increase in platelet count of at least 20 x 10^9/L from baseline within the participant during the treatment period. Increase was calculated as the maximum observed platelet count during the treatment period minus the baseline platelet count.
  • Change From Baseline in Mean of Last 4 Weekly Platelet Counts [ Time Frame: 12 weeks (Weeks 2 - 13) ] [ Designated as safety issue: No ]
    Change from baseline in the mean of the last 4 weekly platelet counts from week 2 to week 13.
  • Weeks With Platelet Count Between 50 and 200 [ Time Frame: 12 weeks (Weeks 2 - 13) ] [ Designated as safety issue: No ]
    Number of weeks with platelet count between 50 x 10^9/L and 200 x 10^9/L inclusive during week 2 to week 13.
  • Rescue Medication(s) [ Time Frame: 12 weeks (Weeks 2 - 13) ] [ Designated as safety issue: No ]
    Requirement for rescue medication(s) during treatment by the participant
  • Efficacy: incidence of increase in platelet count ≥ 20 x 10^9/L from baseline
  • Efficacy: change from baseline in mean of last 4 weekly platelet counts
  • Safety: incidence of adverse events and evaluation of antibody status.
Not Provided
Not Provided
 
P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
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

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) .

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Idiopathic Thrombocytopenic Purpura
  • Drug: Placebo
    Subcutaneously administered, once a week, for 12 weeks
  • Drug: AMG 531
    Subcutaneously administered, once a week, for 12 weeks
  • Placebo Comparator: AMG 531
    Double blinded placebo-controlled study
    Intervention: Drug: AMG 531
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
April 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00603642
20060216
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP