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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 34
Study Start Date: October 2007
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: AMG 531
Double blinded placebo-controlled study
Drug: AMG 531
Subcutaneously administered, once a week, for 12 weeks
Placebo Comparator: Placebo 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
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: NCT00603642

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: NCT00603642     History of Changes
Other Study ID Numbers: 20060216
Study First Received: January 17, 2008
Results First Received: November 18, 2010
Last Updated: February 4, 2011
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

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

ClinicalTrials.gov processed this record on August 26, 2014