Idiopathic Thrombocytopenic Purpura Clinical Trial
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
Verified date | November 2022 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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) .
Status | Completed |
Enrollment | 34 |
Est. completion date | April 13, 2009 |
Est. primary completion date | April 13, 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Amgen |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weeks With Weekly Platelet Response | 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. | 12 weeks (Weeks 2 - 13) | |
Secondary | Increased Platelet Count From Baseline of at Least 20 x 10^9/L | 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. | Baseline, 12 weeks (Weeks 2 - 13) | |
Secondary | Change From Baseline in Mean of Last 4 Weekly Platelet Counts | Change from baseline in the mean of the last 4 weekly platelet counts from week 2 to week 13. | 12 weeks (Weeks 2 - 13) | |
Secondary | Weeks With Platelet Count Between 50 and 200 | 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. | 12 weeks (Weeks 2 - 13) | |
Secondary | Rescue Medication(s) | Requirement for rescue medication(s) during treatment by the participant | 12 weeks (Weeks 2 - 13) |
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