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Study Complete
Sponsor ID
20050162

Safety Study of AMG 531 in Japanese Subjects with ITP

Sponsor ID
20050162
Clinicaltrials.gov ID
NCT00305435
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured by platelet counts by cohort dose-escalation design.

Additional Study Details

Phase
Phase 2
Product
romiplostim
Type
Interventional
Masking
None (Open Label)
Enrollment
12
Additional Study Details

Protocol Summary

Primary Outcome Measures

Incidence of all adverse events including evaluation of antibody status

Timeframe: 1 year

Secondary Outcome Measures

Proportion of subjects who achieve a platelet response

Timeframe: 2 weeks

Locations

No locations found.
Study Info
Age
N/A
Condition
  • Thrombocytopenia
    • Sex
    N/A
    Trial Dates
    Feb 2006 - N/A
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Japanese patients with diagnosis of ITP according to the diagnostic criteria proposed by Research Committee for Idiopathic Hematopoietic Disorders of the Ministry of health, labor and welfare
    Exclusion Criteria:
    - Documented diagnosis of arterial thrombosis in the previous year; history of venous thrombosis and receiving anticoagulation therapy