- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00603642
P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
November 4, 2022 updated by: Amgen
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) .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Subcutaneously administered, once a week, for 12 weeks
|
Placebo Comparator: AMG 531
Double blinded placebo-controlled study
|
Subcutaneously administered, once a week, for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weeks With Weekly Platelet Response
Time Frame: 12 weeks (Weeks 2 - 13)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increased Platelet Count From Baseline of at Least 20 x 10^9/L
Time Frame: Baseline, 12 weeks (Weeks 2 - 13)
|
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)
|
Change From Baseline in Mean of Last 4 Weekly Platelet Counts
Time Frame: 12 weeks (Weeks 2 - 13)
|
Change from baseline in the mean of the last 4 weekly platelet counts from week 2 to week 13.
|
12 weeks (Weeks 2 - 13)
|
Weeks With Platelet Count Between 50 and 200
Time Frame: 12 weeks (Weeks 2 - 13)
|
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)
|
Rescue Medication(s)
Time Frame: 12 weeks (Weeks 2 - 13)
|
Requirement for rescue medication(s) during treatment by the participant
|
12 weeks (Weeks 2 - 13)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2007
Primary Completion (Actual)
April 13, 2009
Study Completion (Actual)
April 13, 2009
Study Registration Dates
First Submitted
January 17, 2008
First Submitted That Met QC Criteria
January 17, 2008
First Posted (Estimate)
January 29, 2008
Study Record Updates
Last Update Posted (Actual)
November 8, 2022
Last Update Submitted That Met QC Criteria
November 4, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Thrombocytopenia
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombocytopenic, Idiopathic
Other Study ID Numbers
- 20060216
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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AmgenCompletedIdiopathic Thrombocytopenic Purpura | Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
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