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
  Purpose

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.


Condition Intervention Phase
Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Biological: AMG 531
Phase 2
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 Extension Study Evaluating the Safety and Efficacy of Long Term Dosing of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 44
Study Start Date: November 2006
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 531 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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00440037

Locations
Japan
Research Site
Sapporo, Hokkaido, Japan, 060-8648
Research Site
Tsukuba, Ibaraki, Japan, 305-8576
Research Site
Isehara-shi, Kanagawa, Japan, 259-1193
Research Site
Sagamihara, Kanagawa, Japan, 228-8555
Research Site
Suita, Osaka, Japan, 565-0871
Research Site
Chuo, Japan, 409-3898
Research Site
Hirakata, Japan, 573-1191
Research Site
Hiroshima, Japan, 730-8619
Research Site
Kumamoto, Japan, 860-8556
Research Site
Tokyo, Japan, 141-8625
Research Site
Tokyo, Japan, 113-8655
Research Site
Tokyo, Japan, 160-8585
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00440037     History of Changes
Other Study ID Numbers: 20060113, Japan CT Notification 18-1055
Study First Received: February 22, 2007
Last Updated: November 8, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Amgen:
AMG 531
ITP
Long term treatment
Japanese
Romiplostim

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

ClinicalTrials.gov processed this record on July 24, 2014