P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

This study has been completed.

Sponsor:

Information provided by:

Amgen

ClinicalTrials.gov Identifier:

NCT00603642

First received: January 17, 2008

Last updated: February 4, 2011

Last verified: February 2011

History of Changes

Results First Received: November 18, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Idiopathic Thrombocytopenic Purpura
Interventions:	Drug: Placebo Drug: AMG 531

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 20 November 2007 through 11 December 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Placebo administered subcutaneously once weekly for 12 weeks
Romiplostim	Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg

Participant Flow: Overall Study

	Placebo	Romiplostim
STARTED	12	22
COMPLETED	12	22
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo administered subcutaneously once weekly for 12 weeks
Romiplostim	Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
Total	Total of all reporting groups

Baseline Measures

	Placebo	Romiplostim	Total
Number of Participants [units: participants]	12	22	34
Age [units: Years] Mean ± Standard Deviation	47.6 ± 13.4	58.5 ± 12.6	54.7 ± 13.7
Gender [units: Participants]
Female	10	14	24
Male	2	8	10
Race/Ethnicity, Customized [units: Participants]
Japanese	12	22	34
Other	0	0	0
Platelet Count [units: 10^9/L] Mean ± Standard Deviation	15.8 ± 8.6	18.4 ± 8.3	17.5 ± 8.4

Outcome Measures

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1. Primary:

Weeks With Weekly Platelet Response [ Time Frame: 12 weeks (Weeks 2 - 13) ]

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2. Secondary:

Increased Platelet Count From Baseline of at Least 20 x 10^9/L [ Time Frame: Baseline, 12 weeks (Weeks 2 - 13) ]

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3. Secondary:

Change From Baseline in Mean of Last 4 Weekly Platelet Counts [ Time Frame: 12 weeks (Weeks 2 - 13) ]

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4. Secondary:

Weeks With Platelet Count Between 50 and 200 [ Time Frame: 12 weeks (Weeks 2 - 13) ]

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5. Secondary:

Rescue Medication(s) [ Time Frame: 12 weeks (Weeks 2 - 13) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00603642 History of Changes
Other Study ID Numbers:	20060216
Study First Received:	January 17, 2008
Results First Received:	November 18, 2010
Last Updated:	February 4, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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