Safety Study of AMG 531 in Japanese Subjects With ITP | NCT00305435

Studies
Safety Study of AMG 531 in Japanese Subjects With ITP

NCT00305435

Sponsor

Kyowa Kirin Co., Ltd.

Status

Completed

Last Update Posted

Jul 5, 2024Actual

Enrollment

12Actual

Phase

Phase 2

Conditions

Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Interventions

Romiplostim (AMG-531)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Nov 2006Actual

Completion Date

Nov 2006Actual

First Submitted Date

Mar 20, 2006

First Submission Date that Met QC Criteria

Mar 20, 2006

First Posted Date

Mar 22, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2024

Last Update Posted Date

Jul 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
romiplostim (AMG-531)	Experimental		Drug: Romiplostim (AMG-531)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Romiplostim (AMG-531)	Drug	Romiplostim (AMG-531)	romiplostim (AMG-531)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of all adverse events including evaluation of antibody status		1 year

Secondary Outcomes

Measure	Description	Time Frame
Proportion of subjects who achieve a platelet response		2 weeks

Other Outcomes

Not provided

Eligibility Module

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, labor and welfare Exclusion Criteria: - Documented diagnosis of arterial thrombosis in the previous year; history of venous thrombosis and receiving anticoagulation therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
MD	Amgen	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19543952	Background	Shirasugi Y, Ando K, Hashino S, Nagasawa T, Kurata Y, Kishimoto Y, Iwato K, Ohtsu T, Berger DP. A phase II, open-label, sequential-cohort, dose-escalation study of romiplostim in Japanese patients with chronic immune thrombocytopenic purpura. Int J Hematol. 2009 Sep;90(2):157-165. doi: 10.1007/s12185-009-0361-y. Epub 2009 Jun 20.

ID	Term
D011696	Purpura, Thrombocytopenic
D016553	Purpura, Thrombocytopenic, Idiopathic

ID	Term
D011693	Purpura
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases