An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP - Study Results

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Idiopathic Thrombocytopenic Purpura Thrombocytopenia Thrombocytopenic Purpura
Intervention:	Biological: Romiplostim

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Subject Enrolled: 24Feb2005 Last Subject Enrolled: 05Jan2010

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
Romiplostim (AMG 531) Cohort 1	Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
Romiplostim (AMG 531) Cohort 2	Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.

Participant Flow: Overall Study

	Romiplostim (AMG 531) Cohort 1	Romiplostim (AMG 531) Cohort 2
STARTED	168	239
COMPLETED	113	175
NOT COMPLETED	55	64
Adverse Event	6	10
Death	6	8
Lost to Follow-up	1	1
Physician Decision	8	2
Pregnancy	0	2
Protocol Violation	2	0
Withdrawal by Subject	10	12
Other	11	2
Noncompliance	1	0
Requirement for alternative therapy	7	15
Protocol-specified Criteria	3	12

Baseline Characteristics

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Reporting Groups

	Description
Romiplostim (AMG 531) Cohort 1	Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
Romiplostim (AMG 531) Cohort 2	Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.

Baseline Measures

	Romiplostim (AMG 531) Cohort 1	Romiplostim (AMG 531) Cohort 2	Total
Number of Participants [units: participants]	168	239	407
Age [units: years] Mean ± Standard Deviation	53.6 ± 17	54.1 ± 18	53.9 ± 17.6
Gender [units: participants]
Female	94	150	244
Male	74	89	163
Race/Ethnicity, Customized [units: participants]
White or Caucasian	149	232	381
Black or African American	5	1	6
Hispanic or Latino	7	2	9
Asian	5	3	8
Other	1	1	2
Native Hawaiian or Other Pacific Islander	1	0	1

Outcome Measures

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1. Primary:

Adverse Events [ Time Frame: Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks. ]

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2. Secondary:

Platelet Response (Definition 1) [ Time Frame: Duration of treatment (up to 201 weeks) ]

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3. Secondary:

Platelet Response (Definition 2) [ Time Frame: Duration of treatment (up to 201 weeks) ]

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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:	NCT00508820 History of Changes
Other Study ID Numbers:	20040209
Study First Received:	July 26, 2007
Results First Received:	January 11, 2012
Last Updated:	January 11, 2012
Health Authority:	Australia: Human Research Ethics Committee Australia: Therapeutic Goods Administration Australia: Department of Health and Ageing Therapeutic Goods Administration France: Ministry of Health Austria: AGES - PharmaMed Austria Institut Wissenschaft & Information Austria: Bundesamt für Sicherheit im Gesundheitswesen Austria: Secretariat of Health Belgium: Directorate general for the protection of Public health: Medicines Belgium: Directorate-General for Medicinal Products Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment Belgium: FPS of Public Health, Food Chain Security and Environment Belgium: Pharmaceutical Inspectorate Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement Belgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne alimentaire et Environnement Canada: Health Canada Czech Republic: State Institute for Drug Control Czech Republic: Statni ustav pro kontrolu leciv Denmark: Central Ethics Committee Denmark: Danish Medicines Agency EU: CHMP France and Sweden: European Medicines Agency France: Afssaps - French Health Products Safety Agency Germany: Federal Institute for Drugs and Medical Devices Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe United States: Western Institutional Review Board Greece: National Organization for Medicines Hungary: National Institute of Pharmacy Ireland: Irish Medicines Board Italy: Local Ethics Committees Italy: Ministry of Health Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research Netherlands: Medicines Evaluation Board Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider Norway: Norwegian Medicines Agency Poland: Drug Institut Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED) Portugal: National Institute of Pharmacy and Medicines Slovakia: Ministry of Health Slovakia: State Institiute for Drug Control Spain: Spanish Drug Agency Sweden: Medical Products Agency Switzerland: Agency for Therapeutic Products Switzerland: Local Ethics Committee Switzerland: Swissmedic (Swiss Agency for Therapeutic Products) United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration United States: Institutional Review Board