AMG 531 Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00415532

Purpose

This is a phase 3b, multi-center, randomized, SOC-controlled, open-label, 52-week treatment study to compare AMG 531 to medical SOC for ITP, with a 6-month Safety Follow-up. Subjects randomized to AMG 531 must complete the taper or discontinuation of medical SOC for ITP as soon as medically feasible after the initiation of AMG 531. After the completion or discontinuation of the study treatment period, any subject who does not transfer in to another AMG 531 study will complete a 6-month Safety Follow-up period.

Condition	Intervention	Phase
Idiopathic Thrombocytopenic Purpura Thrombocytopenia Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Thrombocytopenic Purpura	Biological: AMG531 Drug: Medical Standard of Care for ITP	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, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Controlled, Open-Label Study Evaluating the Efficacy and Tolerability of AMG 531 Versus Medical Standard of Care as Chronic Therapy for Non-Splenectomized Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

Further study details as provided by Amgen:

Primary Outcome Measures:

Number of subjects undergoing a splenectomy by treatment group during the 52-week treatment period. [ Time Frame: Through the 52 week treatment period. ] [ Designated as safety issue: Yes ]
Number of subjects with a treatment failure during the 52-week treatment period. [ Time Frame: Through the 52 week treatment period. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to splenectomy. [ Time Frame: Throught the 52 week treatment period. ] [ Designated as safety issue: Yes ]
Platelet response. [ Time Frame: Through the 52 week treatment period. ] [ Designated as safety issue: No ]
Change in the ITP-PAQ (Patient reported outcome scale) Physical Health domains. [ Time Frame: Through the 52 week treatment period. ] [ Designated as safety issue: No ]

Estimated Enrollment:	210
Study Start Date:	November 2006
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AMG 531	Biological: AMG531 Subcutaneous injection of AMG 531 QW. AMG 531 will be presented as a lyophilized, white powder in 5.0 mL glass vials.
2 Medical standard of care: Medical standard of care treatments are to be selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines.	Drug: Medical Standard of Care for ITP Medical SOC treatments are to be selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines. Medical standard of care treatments will be obtained through the usual commercial routes and will not be provided by Amgen. These drugs will be formulated, packaged, labeled, and stored according to local manufacturer, supplier, and institutional procedures. The investigator will be responsible for obtaining supplies of these medications.

Arms

Assigned Interventions

1: Experimental

AMG 531

Biological: AMG531

Subcutaneous injection of AMG 531 QW. AMG 531 will be presented as a lyophilized, white powder in 5.0 mL glass vials.

2

Medical standard of care: Medical standard of care treatments are to be selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines.

Drug: Medical Standard of Care for ITP

Medical SOC treatments are to be selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines. Medical standard of care treatments will be obtained through the usual commercial routes and will not be provided by Amgen. These drugs will be formulated, packaged, labeled, and stored according to local manufacturer, supplier, and institutional procedures. The investigator will be responsible for obtaining supplies of these medications.

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 ITP according to ASH guidelines
If subject is > 60 years of age, subject has a written bone marrow biopsy report confirming the diagnosis of ITP
Subject has received at least 1 prior therapy for ITP
Subject has a platelet count < 50,000 or their platelet count falls to < 50,000 during or after a clinically-indicated taper or discontinuation of current ITP therapy
Before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria:

Subject has had a splenectomy for any reason
Subject has an active malignancy
Subject has a history of cancer, other than basal cell carcinoma or cervical carcinoma in situ, with treatment or active disease within 5 years
Subject has a known history of bone marrow stem cell disorder
Subject has participated in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), AMG 531, or a thrombopoietic protein
Subject is receiving other investigational agents or procedures
Subject is currently enrolled in, or has completed within the last 30 days, another investigational device or drug study
Subject is pregnant or breast feeding
Subject is not using adequate contraceptive precautions
Subject has known sensitivity to any recombinant E coli-derived product
Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and does not have a legally acceptable representative
Subject has any kind of disorder that compromises the ability of the subject to comply with study procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415532

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:	20060131
Study First Received:	December 21, 2006
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00415532
Health Authority:	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: Federal Ministry for Health and Women; Austria: Secretariat of Health; Belgium: Directorate general for the protection of Public health: Medicines; 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; Canada: Health Canada; Canada: Health Products and Food Branch; Czech Republic: State Institute for Drug Control; Czech Republic: Statni ustav pro kontrolu leciv; EU: CHMP; European Union: European Medicines Agency; Switzerland: Agency for Therapeutic Products; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; United States: Institutional Review Board; 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; Hungary: National Institute of Pharmacy; Italy: Ministry of Health; 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: National Institute of Pharmacy and Medicines; Spain: Spanish Agency of Medicines; Spain: Spanish Drug Agency; Sweden: Medical Products Agency

Keywords provided by Amgen:

immune thrombocytopenic purpura
idiopathic thrombocytopenic purpura
immune (idiopathic) thrombocytopenic purpura
splenectomy
platelet
AMG 531

thrombopoietin
blood disorder
bleeding disorder
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