Open Label Extension Study of AMG 531 in Japanese Subjects With ITP

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00440037
First received: February 22, 2007
Last updated: November 8, 2012
Last verified: November 2012

February 22, 2007
November 8, 2012
November 2006
July 2011   (final data collection date for primary outcome measure)
The primary endpoint is the incidence of all adverse events including clinically significant changes in laboratory values. [ Time Frame: Entire duration of the study ] [ Designated as safety issue: Yes ]
The primary endpoint is the incidence of all adverse events including clinically significant changes in laboratory values.
Complete list of historical versions of study NCT00440037 on ClinicalTrials.gov Archive Site
  • Incidence of anti AMG 531 antibody formation [ Time Frame: Entire duration of the study ] [ Designated as safety issue: No ]
  • Incidence of platelet response (platelet response is defined as a doubling of baseline platelet counts and more than 50 x 10^9/L; baseline platelet counts is that obtained in the previous study) [ Time Frame: Entire duration of the study ] [ Designated as safety issue: No ]
  • Proportion of subjects able to reduce or discontinue their concurrent ITP therapies (for subjects that are receiving oral corticosteroids at a constant dose and schedule at the screening visit) [ Time Frame: Entire duration of the study ] [ Designated as safety issue: No ]
  • Change from baseline in PRO endpoints at each time point (baseline PRO is obtained at Day 1 predose) [ Time Frame: Entire duration of the study ] [ Designated as safety issue: No ]
  • Incidence of anti AMG 531 antibody formation
  • Incidence of platelet response (platelet response is defined as a doubling of baseline platelet counts and more than 50 x 10^9/L; baseline platelet counts is that obtained in the previous study)
  • Proportion of subjects able to reduce or discontinue their concurrent ITP therapies (for subjects that are receiving oral corticosteroids at a constant dose and schedule at the screening visit)
  • Change from baseline in PRO endpoints at each time point (baseline PRO is obtained at Day 1 predose)
Not Provided
Not Provided
 
Open Label Extension Study of AMG 531 in Japanese Subjects With ITP
An Open Label Extension Study Evaluating the Safety and Efficacy of Long Term Dosing of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

The purpose of this study is to assess the safety and efficacy of long term dosing of AMG 531 in thrombocytopenic Japanese subjects with ITP.

It is anticipated that AMG 531 will be a safe and well tolerated in long term treatment and that AMG 531 will effectively raise and maintain platelet counts to a desired therapeutic range, when individual dose adjustments based on platelet counts are permitted.

This study is available to subjects who have completed any previous AMG 531 ITP study in Japan and meet the eligibility criteria of this study.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Biological: AMG 531
AMG 531 will be administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG 531 is 10 μg/kg. AMG 531 will be supplied as a sterile, white, preservative-free, lyophilized powder in 5 mL glass vials containing 0.6 mg of protein per vial, and a protein concentration of 0.5 mg/mL when reconstituted with 1.2 mL of sterile water for injection.
Other Name: Romiplostim
Experimental: AMG 531
Intervention: Biological: AMG 531
Arranz R, García-Noblejas A, Grande C, Cannata-Ortiz J, Sánchez JJ, García-Marco JA, Aláez C, Pérez-Calvo J, Martínez-Sánchez P, Sánchez-González B, Canales MA, Conde E, Martín A, Arranz E, Terol MJ, Salar A, Caballero D. First-line treatment with rituximab-hyperCVAD alternating with rituximab-methotrexate-cytarabine and followed by consolidation with 90Y-ibritumomab-tiuxetan in patients with mantle cell lymphoma. Results of a multicenter, phase 2 pilot trial from the GELTAMO group. Haematologica. 2013 Oct;98(10):1563-70. doi: 10.3324/haematol.2013.088377. Epub 2013 Jun 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
September 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Subjects must have previously completed an AMG 531 ITP study in Japan.
  • Platelet count taken at the screening visit must be < 50 x 109/L.
  • Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria

  • Any significant change in medical history since completion of the previous AMG 531 ITP study including bone marrow stem cell disorders or new active malignancies
  • known positive result from a test for neutralizing antibodies to AMG 531 in the previous AMG 531 ITP study
  • Currently receiving any treatment for ITP except oral corticosteroids, azathioprine and/or danazol administered at a constant dose and schedule from at least 4 weeks prior to the screening visit
  • received intravenous immunoglobulin, anti-D immunoglobulin, or any drug administered to increase platelet counts (eg, immunosuppressants etc) within 1 week before the screening visit
  • received anti-malignancy agents (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, Interferon-alfa etc) within 4 weeks before the screening visit
  • received any monoclonal antibody drugs (eg, rituximab etc) within 8 weeks before the screening visit
  • Less than 4 weeks since receipt of any therapeutic drug or device that is not Ministry of Health, Labor and Welfare (MHLW) approved for any indication before the screening visit (excluding AMG 531)
  • Pregnant or breast feeding
  • Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
  • known severe drug hypersensitivity
  • Concerns for subject's compliance with the protocol
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00440037
20060113, Japan CT Notification 18-1055
No
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP