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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 Response

Number 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

Page last updated: August 23, 2015

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