Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

NCT00116688 | Completed Phase 3 Results

• 1 other identifier: 20030213
• Study Type: interventional
• Target: 313
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Thrombocytopenia; Idiopathic Thrombocytopenic Purpura

Keywords

Immune (Idiopathic) Thrombocytopenic Purpura (ITP); Thrombocytopenic

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Participants with one or more occurrences of one or more adverse events up to 8 weeks after the end of treatment. Participants with more than one event were only counted once.

  Duration of treatment plus 8 weeks (up to 285 weeks)

Secondary Outcomes (7)

• Number of Participants With a Platelet Response

  Duration of treatment (up to 277 weeks)

• Number of Participants With a Reduction or Discontinuation of Concurrent ITP Therapies

  Duration of treatment (up to 277 weeks)

• Change From Baseline in ITP Patient Assessment Questionnaire

  Baseline to Week 48

• Change From Baseline in Short Form 36 (SF-36)

  Baseline to Week 48

• Change From Baseline in Euroqol-5D (EQ-5D) Index Score

  Baseline to Week 48

Study Arms (1)

Romiplostim

EXPERIMENTAL

Romiplostim weekly subcutaneous dosing based on screening weight and platelet count. Starting dose of 1 µg/kg up to a maximum dose of 10 µg/kg.

Biological: Romiplostim

Interventions

Romiplostim BIOLOGICAL

Romiplostim is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.

Also known as: AMG 531, Nplate

Romiplostim

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have previously completed a romiplostim ITP study
• Platelet count ≤ 50 x 10 \^9/L
• Written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Related Publications (5)

• 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.

  PMID: 18981291 BACKGROUND

• 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.

  PMID: 23432528 BACKGROUND

• 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;

  BACKGROUND

• 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;

  BACKGROUND

• Kuter DJ, Mufti GJ, Bain BJ, Hasserjian RP, Davis W, Rutstein M. Evaluation of bone marrow reticulin formation in chronic immune thrombocytopenia patients treated with romiplostim. Blood. 2009 Oct 29;114(18):3748-56. doi: 10.1182/blood-2009-05-224766. Epub 2009 Aug 11.

  PMID: 19671919 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic; Purpura, Thrombocytopenic

Interventions

romiplostim

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Purpura; Blood Coagulation Disorders; Thrombotic Microangiopathies; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 1, 2005
• Study Start: August 1, 2004
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: December 18, 2013
• Results First Posted: April 6, 2011

Record last verified: 2013-11