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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00508820
First received: July 26, 2007
Last updated: January 11, 2012
Last verified: January 2012
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks. ] [ Designated as safety issue: Yes ]
    One or more occurences of one or more adverse events within the participant during the study. Participants with more than one event were only counted once


Secondary Outcome Measures:
  • Platelet Response (Definition 1) [ Time Frame: Duration of treatment (up to 201 weeks) ] [ Designated as safety issue: No ]
    Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of >=50 x 10^9/L

  • Platelet Response (Definition 2) [ Time Frame: Duration of treatment (up to 201 weeks) ] [ Designated as safety issue: No ]
    Platelet response using definition 2 (a platelet count increase of >=20 x 109/L from baseline)


Enrollment: 407
Study Start Date: February 2005
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Other Name: romiplostim

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
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: Federal Agency for Medicines and Health Products, FAMHP
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

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

Additional relevant MeSH terms:
Thrombocytopenia
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Blood Coagulation Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases

ClinicalTrials.gov processed this record on September 18, 2014