Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Thrombocytopenia; Idiopathic Thrombocytopenic Purpura
Intervention: Romiplostim (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
Summary
The purpose of this study is to determine the safety of romiplostim as a long-term treatment
in thrombocytopenic subjects with ITP, to evaluate the long-term platelet response to
romiplostim, and to evaluate changes in patient reported outcomes due to the use of
romiplostim. Participants must have previously completed a romiplostim ITP study.
Clinical Details
Official title: An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants With Adverse Events
Secondary outcome: Number of Participants With a Platelet ResponseNumber of Participants With a Reduction or Discontinuation of Concurrent ITP Therapies Change From Baseline in ITP Patient Assessment Questionnaire Change From Baseline in Short Form 36 (SF-36) Change From Baseline in Euroqol-5D (EQ-5D) Index Score Change From Baseline in Euroqol-5D (EQ-5D) Visual Analogue Scale (VAS) Patient Global Assessment
Eligibility
Minimum age: 1 Year.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Must have previously completed a romiplostim ITP study
- Platelet count ≤ 50 x 10 ^9/L
- Written informed consent
Exclusion Criteria:
- Bone marrow stem cell disorder or new active malignancies diagnosed since enrollment
in the previous romiplostim ITP study
- Received any alkylating agents within 4 weeks before screening visit or anticipated
use during the time of the proposed study
- Currently enrolled in or has not yet completed at least 4 weeks since ending device
or drug trial(s) (other than the previous romiplostim ITP study), or subject is
receiving other investigational agent(s) other than romiplostim
- Not using adequate contraceptive precautions
- Not available for follow-up assessments
- Has any kind of disorder that compromises the ability of the participant to give
informed consent and does not have a legally-acceptable representative and/or is
unable to comply with study procedures.
Locations and Contacts
Additional Information
AmgenTrials clinical trials website
Related publications: Bussel JB, Kuter DJ, Pullarkat V, Lyons RM, Guo M, Nichol JL. Safety and efficacy of long-term treatment with romiplostim in thrombocytopenic patients with chronic ITP. Blood. 2009 Mar 5;113(10):2161-71. doi: 10.1182/blood-2008-04-150078. Epub 2008 Nov 3. Erratum in: Blood. 2009 May 7;113(19):4822. Kuter DJ, Bussel JB, Newland A, Baker RI, Lyons RM, Wasser J, Viallard JF, Macik G, Rummel M, Nie K, Jun S. Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy. Br J Haematol. 2013 May;161(3):411-23. doi: 10.1111/bjh.12260. Epub 2013 Feb 22. Terrell D, George J, Bussel J, Lyons R, Pullarkat V, Redner R, Nie, Selleslag D, Nie K, Woodard P.Home administration of romiplostim by patients with chronic immune thrombocytopenia (ITP).Journal-001500; Terrell D, George J, Bussel J, Lyons R, Pullarkat V, Redner R, Nie, Selleslag D, Nie K, Woodard P.Home administration of romiplostim by patients with chronic immune thrombocytopenia (ITP).Journal-001752;
Starting date: August 2004
Last updated: November 25, 2013
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