- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00305435
Safety Study of AMG 531 in Japanese Subjects With ITP
September 11, 2014 updated by: Kyowa Kirin Co., Ltd.
An Open Label Phase 2 Study Evaluating the Safety of Starting Dose of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured by platelet counts by cohort dose-escalation design.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured by platelet counts by cohort dose-escalation design.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
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, labor and welfare Exclusion Criteria: - Documented diagnosis of arterial thrombosis in the previous year; history of venous thrombosis and receiving anticoagulation therapy
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: romiplostim (AMG-531)
|
Romiplostim (AMG-531)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of all adverse events including evaluation of antibody status
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects who achieve a platelet response
Time Frame: 2 weeks
|
2 weeks
|
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.
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
February 1, 2006
Primary Completion (ACTUAL)
November 1, 2006
Study Completion (ACTUAL)
November 1, 2006
Study Registration Dates
First Submitted
March 20, 2006
First Submitted That Met QC Criteria
March 20, 2006
First Posted (ESTIMATE)
March 22, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
September 12, 2014
Last Update Submitted That Met QC Criteria
September 11, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20050162
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.
Clinical Trials on Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
-
AmgenCompletedThrombocytopenia | Immune Thrombocytopenia | Idiopathic Thrombocytopenic Purpura | Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenic PurpuraUnited States, Canada, Australia
-
AmgenCompletedIdiopathic Thrombocytopenic Purpura | Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
-
AmgenCompletedThrombocytopenia | Idiopathic Thrombocytopenic Purpura | Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenic Purpura
-
AmgenCompletedThrombocytopenia | Idiopathic Thrombocytopenic Purpura | Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenic Purpura
-
AmgenCompletedThrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITPUnited States, Canada, Australia, Spain
-
Neufeld, Ellis J, MD, PhDGenentech, Inc.; Biogen; Glaser Pediatric Research Network; Terrana ITP Research...CompletedImmune Thrombocytopenic Purpura (ITP) | Idiopathic Thrombocytopenic Purpura (ITP)United States
-
Gruppo Italiano Malattie EMatologiche dell'AdultoNot yet recruitingITP - Immune Thrombocytopenia | Chronic ITP | Refractory ITP
-
Assiut UniversityAssociation for Training, Education, and Research in Hematology, Immunology...Not yet recruitingITP - Immune Thrombocytopenia
-
Protalex, Inc.TerminatedPhase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITPIdiopathic Thrombocytopenic Purpura (ITP)Australia, New Zealand
-
CSL LimitedCompletedIdiopathic Thrombocytopenic Purpura (ITP)Australia
Clinical Trials on Romiplostim (AMG-531)
-
Kyowa Kirin Co., Ltd.CompletedImmune (Idiopathic) Thrombocytopenic Purpura (ITP)Japan
-
AmgenCompletedIdiopathic Thrombocytopenic PurpuraItaly, United States, Germany, Czechia, United Kingdom, Australia, Spain, Poland, France
-
AmgenCompleted
-
AmgenCompletedMyelodysplastic Syndromes | Thrombocytopenia | MDS | Hematology
-
AmgenCompletedIdiopathic Thrombocytopenic Purpura | Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
-
AmgenCompletedThrombocytopenia | Idiopathic Thrombocytopenic Purpura
-
AmgenCompletedIdiopathic Thrombocytopenic Purpura
-
AmgenCompletedDetermination of Safe Dose of Romiplostim (AMG 531) in Patients With Myelodysplastic Syndromes (MDS)Myelodysplastic Syndromes | Thrombocytopenia | MDS | Refractory Cytopenias
-
NYU Langone HealthNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Thrombocytopenia | Refractory Multiple MyelomaUnited States
-
AmgenCompletedThrombocytopenia | Immune Thrombocytopenia | Idiopathic Thrombocytopenic Purpura | Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenic PurpuraUnited States, Canada, Australia