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Safety Study of AMG 531 in Japanese Subjects With ITP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00305435
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Drug: Romiplostim (AMG-531) Phase 2

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  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Phase 2 Study Evaluating the Safety of Starting Dose of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
Study Start Date : February 2006
Primary Completion Date : November 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Romiplostim
U.S. FDA Resources

Arm Intervention/treatment
Experimental: romiplostim (AMG-531) Drug: Romiplostim (AMG-531)
Romiplostim (AMG-531)



Primary Outcome Measures :
  1. Incidence of all adverse events including evaluation of antibody status [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Proportion of subjects who achieve a platelet response [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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, labor and welfare Exclusion Criteria: - Documented diagnosis of arterial thrombosis in the previous year; history of venous thrombosis and receiving anticoagulation therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305435


Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
Investigators
Study Director: MD Amgen

Additional Information:
Publications:
Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT00305435     History of Changes
Other Study ID Numbers: 20050162
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014

Keywords provided by Kyowa Hakko Kirin Co., Ltd:
AMG 531, ITP, Phase 2, Japanese

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