Clinical trial NCT00603642: P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Thrombocytopenic Purpura
Keywords: AMG 531
Idiopathic Thrombocytopenic Purpura
ITP
Thrombocytopenia
Japan
Placebo controlled
Phase 3
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2008-01-29
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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) .


Eligibility 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

Primary outcomes:
measure: Weeks With Weekly Platelet Response
timeFrame: 12 weeks (Weeks 2 - 13)
Secondary outcomes:
measure: Increased Platelet Count From Baseline of at Least 20 x 10^9/L
timeFrame: Baseline, 12 weeks (Weeks 2 - 13)
measure: Change From Baseline in Mean of Last 4 Weekly Platelet Counts
timeFrame: 12 weeks (Weeks 2 - 13)
measure: Weeks With Platelet Count Between 50 and 200
timeFrame: 12 weeks (Weeks 2 - 13)
measure: Rescue Medication(s)
timeFrame: 12 weeks (Weeks 2 - 13)
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: