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P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

NCT00603642 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-11-08

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Summary

The purpose of this study is to evaluate the efficacy and safety of AMG 531 compared with placebo in thrombocytopenic Japanese subjects with immune (idiopathic) thrombocytopenic purpura (ITP) .

Conditions

  • Idiopathic Thrombocytopenic Purpura

Interventions

DRUG

Placebo

Subcutaneously administered, once a week, for 12 weeks

DRUG

AMG 531

Subcutaneously administered, once a week, for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-01
Primary Completion
2009-04-13
Completion
2009-04-13

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Entities

Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00603642 on ClinicalTrials.gov