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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00116688
• Date of registration: 30/06/2005
• Prospective Registration: No
• Primary sponsor: Amgen
• Public title: Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
• Scientific 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)
• Date of first enrolment: August 2004
• Target sample size: 313
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00116688
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion 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.



Age minimum: 1 Year
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Thrombocytopenic Purpura

Thrombocytopenia

Intervention(s)

Biological: Romiplostim

Primary Outcome(s)

Number of Participants With Adverse Events [Time Frame: Duration of treatment plus 8 weeks (up to 285 weeks)]

Secondary Outcome(s)

Change From Baseline in Short Form 36 (SF-36) [Time Frame: Baseline to Week 48]

Change From Baseline in Euroqol-5D (EQ-5D) Visual Analogue Scale (VAS) [Time Frame: Baseline to Week 48]

Change From Baseline in Euroqol-5D (EQ-5D) Index Score [Time Frame: Baseline to Week 48]

Number of Participants With a Reduction or Discontinuation of Concurrent ITP Therapies [Time Frame: Duration of treatment (up to 277 weeks)]

Change From Baseline in ITP Patient Assessment Questionnaire [Time Frame: Baseline to Week 48]

Number of Participants With a Platelet Response [Time Frame: Duration of treatment (up to 277 weeks)]

Patient Global Assessment [Time Frame: Week 1 and Week 48]

Secondary ID(s)

20030213

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/04/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00116688