An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00508820

Purpose

This protocol will provide open label romiplostim to adult thrombocytopenic subjects. Romiplostim will be administered by subcutaneous injection once per week. Dose adjustment will be based on platelet counts, and will be allowed throughout the duration of the study. Rescue therapies are allowed at any time during the study. Reductions in concurrent ITP therapies may occur at any time when platelet counts are > 50,000.

Condition	Intervention	Phase
Idiopathic Thrombocytopenic Purpura Thrombocytopenia Thrombocytopenic Purpura	Biological: Romiplostim	Phase III

Genetics Home Reference related topics: hemophilia thrombotic thrombocytopenic purpura

Drug Information available for: Amphetamine AMG 531 Methamphetamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Further study details as provided by Amgen:

Primary Outcome Measures:

Incidence of adverse events, including clinically significant changes in laboratory values and incidence of antibody formation. [ Time Frame: Through the end of study. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of platelet response as defined by a doubling of the baseline platelet count and a platelet count ≥ 50 x 10^ 9/ L. The incidence of a platelet count increase of 20 x 10^ 9/L over baseline. [ Time Frame: Through the end of study. ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	February 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Romiplostim	Biological: Romiplostim Romiplostim will be administered subcutaneously QW. Romiplostim will be manufactured and packaged and distributed using Amgen's clinical study investigational product distribution procedures. Romiplostim is presented as a lyophilized, white powder in 5.0 mL glass vials.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is ≥ 18 years of age
Subject has a diagnosis of immune (idiopathic) thrombocytopenic purpura per the American Society of Hematology guidelines
If Subject is > 60 years of age, subject has a written bone marrow aspiration and/or biopsy report consistent with a diagnosis of ITP
Subject has received at least 1 prior therapy for ITP
Subject's platelet count is ≤ 30,000 or the subject is experiencing bleeding that is uncontrolled with conventional therapies
Subject (or legally-acceptable representative) is willing and able to provide written informed consent

Exclusion Criteria:

Subject has a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder
Subject has participated in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), or related platelet product
Subject has a known hypersensitivity to any recombinant E coli-derived product
Subject has received any therapeutic drug or device that is not approved by the local regulatory health agency for any indication within 4 weeks of Screening
Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator
Subject is pregnant or breast feeding
Investigator has concerns regarding the subject's ability to comply with the protocol procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508820

Contacts

Contact: Amgen Call Center

866-572-6436

Show 76 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20040209
Study First Received:	July 26, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00508820
Health Authority:	Netherlands: Medicines Evaluation Board; Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider; 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; Spain: Spanish Drug Agency; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; United States: Institutional Review Board; United States: Western Institutional Review Board; Ireland: Irish Medicines Board; Switzerland: Swissmedic (Swiss Agency for Therapeutic Products); Switzerland: Local Ethics Committee; Switzerland: Agency for Therapeutic Products; Slovakia: State Institiute for Drug Control; Slovakia: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Norway: Norwegian Medicines Agency; Denmark: Danish Medicines Agency; Denmark: Central Ethics Committee; Italy: Ministry of Health; Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research; Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: Human Research Ethics Committee; Australia: Therapeutic Goods Administration; 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; EU: CHMP; France and Sweden: European Medicines Agency; France: Afssaps - French Health Products Safety Agency; France: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe; Greece: National Organization for Medicines; Hungary: National Institute of Pharmacy; Italy: Local Ethics Committees

Keywords provided by Amgen:

Platelet
AMG 531
Thrombopoietin
blood disorder
bleeding disorder

immune thrombocytopenic purpura
idiopathic thrombocytopenic purpura
immune (idiopathic) thrombocytopenic purpura
TPO
thrombopoietic protein

Study placed in the following topic categories:

Purpura
Autoimmune Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemorrhage
Hemostatic Disorders
Purpura, Thrombocytopenic

Thrombocytopathy
Signs and Symptoms
Methamphetamine
Thrombocytopenia
Hemorrhagic Disorders
Thrombocytopenic purpura, autoimmune
Purpura, Thrombocytopenic, Idiopathic
Amphetamine

Additional relevant MeSH terms:

Skin Manifestations
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009