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Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim
This study is currently recruiting participants.
Verified November 2011 by Amgen

First Received on June 10, 2010.   Last Updated on November 21, 2011   History of Changes
Sponsor: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT01143038
  Purpose

The purpose of this study is to describe the number of months with a subject platelet response over a 12 month treatment period and to describe ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim


Condition Intervention Phase
Idiopathic Thrombocytopenic Purpura
Other: AMG 531
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Interventional Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Number of months with a subject platelet response over a 12 month treatment period. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe subject incidence of ITP remission. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To describe subject incidence of splenectomy. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To describe subject incidence of adverse events. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: September 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 531
All subjects will receive romiplostim.
Other: AMG 531
Romiplostim will be administered weekly by SC injection for 12 months at a starting dose of 1 mcg/kg.
Other Name: Biological: romiplostim

  Eligibility

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

Inclusion Criteria:

  • Subject has been diagnosed with primary ITP according to the ASH guidelines (George et al, 1996) and previously received only 1st line therapies First line therapy is defined as corticosteroids, IVIG, Anti-D and Vinca Alkaloids (used for the treatment of ITP related thrombocytopenia only). A platelet transfusion at any time during the six month period since the original diagnosis would not exclude the subject from study participation
  • Initial diagnosis of primary ITP within 6 months of enrollment
  • Age ≥ 18 years at screening
  • A single platelet count ≤ 30 x 10⁹/L at any time during the screening period
  • Subject or subject's legally acceptable representative has provided informed consent

Exclusion Criteria:

  • Known history of a bone marrow stem cell disorder
  • Surgical resection of the spleen
  • Subject has a history of cancer or current malignancy other than basal cell carcinoma or cervical cancer in-situ with active treatment or disease within 5 years of screening
  • Known history of congenital thrombocytopenia
  • Known history of hepatitis B, hepatitis C, or human immunodeficiency virus
  • Positive H. pylori by urea breath test or stool antigen test at screening
  • Known history of systemic lupus erythematosus, Evans syndrome, or autoimmune neutropenia
  • Known history of antiphospholipid antibody syndrome or positive for lupus anticoagulant
  • Known history of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura
  • Previous history of recurrent venous thromboembolism or thrombotic events or an occurrence within 5 years of enrollment.
  • Previous use of romiplostim, PEG-rHuMGDF, eltrombopag, rHuTPO or any platelet producing agent
  • Rituximab (for any indication) or Mercaptopurine (6-MP) or anticipated use during the time of the proposed study
  • All hematopoietic growth factors including IL-11 (oprelvekin) within 4 weeks before the screening visit
  • Alkylating agents use at any time before or during the screening visit or anticipated during the time of the proposed study
  • Known hypersensitivity to any recombinant E coli-derived product (eg, Infergen, Neupogen, Somatropin, and Actimmune)
  • Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
  • Subject will have any other investigational procedures performed while enrolled in this clinical study
  • Subject is pregnant or breast feeding, or planning to become pregnant within 5 weeks after the end of treatment
  • Female subject of child bearing potential is not willing to use, in combination with her partner, highly effective contraception during treatment and for 5 months after the end of treatment
  • Subject has previously enrolled into a romiplostim study
  • Subject will not be available for protocol required study visits, to the best of the subject's and investigator's knowledge
  • Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01143038

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 35 Study Locations
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: NCT01143038     History of Changes
Other Study ID Numbers: 20080435
Study First Received: June 10, 2010
Last Updated: November 21, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Agenzia Italiana del Farmaco
Italy: Ministry of Health
Netherlands:Centrale Commissie Mensgebonden Onderzoek (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
France: Afssaps - French Health Products Safety Agency

Keywords provided by Amgen:
AMGEN
ITP

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

ClinicalTrials.gov processed this record on May 24, 2012