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
2 other identifiers
interventional
44
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2006
Longer than P75 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 22, 2007
CompletedFirst Posted
Study publicly available on registry
February 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
January 21, 2020
CompletedJanuary 21, 2020
January 1, 2020
4.7 years
February 22, 2007
December 5, 2019
January 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adverse Events Including Clinically Significant Changes in Laboratory Values.
Subjects who reported at least 1 adverse event after beginning treatment with romiplostim in this study
Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)
Secondary Outcomes (4)
Incidence of Anti AMG 531 Antibody Formation
Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)
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)
Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)
Percentage 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)
Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)
Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose)
By Week 48
Study Arms (1)
AMG 531
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Research Site
Sapporo, Hokkaido, 060-8648, Japan
Research Site
Tsukuba, Ibaraki, 305-8576, Japan
Research Site
Isehara-shi, Kanagawa, 259-1193, Japan
Research Site
Sagamihara, Kanagawa, 228-8555, Japan
Research Site
Suita, Osaka, 565-0871, Japan
Research Site
Chūō, 409-3898, Japan
Research Site
Hirakata, 573-1191, Japan
Research Site
Hiroshima, 730-8619, Japan
Research Site
Kumamoto, 860-8556, Japan
Research Site
Moriguchi, 570-8507, Japan
Research Site
Tokyo, 113-8655, Japan
Research Site
Tokyo, 141-8625, Japan
Research Site
Tokyo, 160-8585, Japan
Related Publications (1)
Arranz R, Garcia-Noblejas A, Grande C, Cannata-Ortiz J, Sanchez JJ, Garcia-Marco JA, Alaez C, Perez-Calvo J, Martinez-Sanchez P, Sanchez-Gonzalez B, Canales MA, Conde E, Martin 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.
PMID: 23753021DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Research & Development Planning Department , Research & Development Division
- Organization
- Kyowa Kirin Co., Ltd.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2007
First Posted
February 26, 2007
Study Start
November 1, 2006
Primary Completion
July 1, 2011
Study Completion
September 1, 2011
Last Updated
January 21, 2020
Results First Posted
January 21, 2020
Record last verified: 2020-01