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Study Complete
Sponsor ID
20030213

Study of Romiplostim (AMG 531) in Thrombocytopenic Patients with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Sponsor ID
20030213
Clinicaltrials.gov ID
NCT00116688
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
romiplostim
Type
Interventional
Masking
None (Open Label)
Enrollment
313
Additional Study Details

Protocol Summary

Primary Outcome Measures

Adverse Events

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

Secondary Outcome Measures

Platelet Response

Timeframe: Duration of treatment (up to 277 weeks)

Reduction or Discontinuation of Concurrent ITP Therapies

Timeframe: Duration of treatment (up to 277 weeks)

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
1+ years
Condition
  • Thrombocytopenia
    • Sex
    All
    Trial Dates
    Aug 2004 - Jan 2010
    Inclusion and 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.