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

Primary Purpose

Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
AMG 531
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune (Idiopathic) Thrombocytopenic Purpura (ITP) focused on measuring AMG 531, ITP, Long term treatment, Japanese, Romiplostim

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AMG 531

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of Anti AMG 531 Antibody Formation
Subjects with positive anti-AMG 531 antibodies (either to the peptide portion of AMG 531 or to the intact molecule) and antibodies that cross-react with endogenous thrombopoietin (TPO)
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)
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)
Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose)
Short Form 36 (SF-36): The SF-36 has 36 questions with 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. In addition to deriving a score for each of the domains, the SF-36 generates 2 summary scores: a physical component summary (PCS) and a mental component summary (MCS). These 8 domains and 2 summary scores are scored from 0 to 100, with higher scores indicating better health status. The official version in Japanese was used in this study. Euroqol-5 Dimensions (EQ-5D): The EQ-5D is a patient-completed, multidimensional measure of HRQOL. EQ-5D index values range from -0.59 to 1.00. The EQ-5D visual analogue scale (VAS) records the respondents' self-rated health status on a vertical graduated (0 to 100) visual analogue scale. Higher EQ-5D Index and VAS scores represent better health status. The official version in Japanese was used in this study.

Full Information

First Posted
February 22, 2007
Last Updated
January 10, 2020
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00440037
Brief Title
Open Label Extension Study of AMG 531 in Japanese Subjects With ITP
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Romiplostim was administered by subcutaneous (SC) injection once per week. If subjects entered the extension study within 12 weeks from the last investigational product administration in the previous study and had shown an increase in platelet counts ≥ 20 x 109/L from baseline at least once during the 13-week treatment period (excluding 4 weeks after receiving rescue medication), they were treated with romiplostim at the same weekly dose (last dose on study) received in the previous study. Otherwise, subjects were treated with romiplostim at a starting dose of 3 μg/kg. Dose adjustment based on platelet counts was allowed throughout the treatment period to allow subjects to maintain platelet counts in the target range of ≥ 50 to ≤ 200 x 109/L, up to a maximum permitted dose of 10 μg/kg.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Keywords
AMG 531, ITP, Long term treatment, Japanese, Romiplostim

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMG 531
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
AMG 531
Other Intervention Name(s)
Romiplostim
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events Including Clinically Significant Changes in Laboratory Values.
Description
Subjects who reported at least 1 adverse event after beginning treatment with romiplostim in this study
Time Frame
Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)
Secondary Outcome Measure Information:
Title
Incidence of Anti AMG 531 Antibody Formation
Description
Subjects with positive anti-AMG 531 antibodies (either to the peptide portion of AMG 531 or to the intact molecule) and antibodies that cross-react with endogenous thrombopoietin (TPO)
Time Frame
Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)
Title
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
Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)
Title
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)
Time Frame
Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)
Title
Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose)
Description
Short Form 36 (SF-36): The SF-36 has 36 questions with 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. In addition to deriving a score for each of the domains, the SF-36 generates 2 summary scores: a physical component summary (PCS) and a mental component summary (MCS). These 8 domains and 2 summary scores are scored from 0 to 100, with higher scores indicating better health status. The official version in Japanese was used in this study. Euroqol-5 Dimensions (EQ-5D): The EQ-5D is a patient-completed, multidimensional measure of HRQOL. EQ-5D index values range from -0.59 to 1.00. The EQ-5D visual analogue scale (VAS) records the respondents' self-rated health status on a vertical graduated (0 to 100) visual analogue scale. Higher EQ-5D Index and VAS scores represent better health status. The official version in Japanese was used in this study.
Time Frame
By Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Research Site
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Research Site
City
Isehara-shi
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Research Site
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
228-8555
Country
Japan
Facility Name
Research Site
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Research Site
City
Chuo
ZIP/Postal Code
409-3898
Country
Japan
Facility Name
Research Site
City
Hirakata
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Research Site
City
Hiroshima
ZIP/Postal Code
730-8619
Country
Japan
Facility Name
Research Site
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Research Site
City
Moriguchi
ZIP/Postal Code
570-8507
Country
Japan
Facility Name
Research Site
City
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Research Site
City
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Research Site
City
Tokyo
ZIP/Postal Code
160-8585
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
23753021
Citation
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.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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