Open Label Extension Study of AMG 531 in Japanese Subjects With ITP
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00440037
First received: February 22, 2007
Last updated: November 8, 2012
Last verified: November 2012
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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:
Genetics Home Reference related topics:
thrombotic thrombocytopenic purpura
Drug Information available for:
Romiplostim
U.S. FDA Resources
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
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
| 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 June 18, 2013