Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440037
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2007-02-22
Brief Title:
Open Label Extension Study of AMG 531 in Japanese Subjects With ITP
Sponsor:
Kyowa Kirin Co Ltd
Organization:
Kyowa Kirin Co Ltd
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 109L 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 μgkg 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 109L up to a maximum permitted dose of 10 μgkg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Japan CT Notification 18-1055 | REGISTRY | Pharmaceuticals and Medical Devices Agency PMDA | None |