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Clinical Trials/EUCTR2006-003700-18-BE
EUCTR2006-003700-18-BEActive, not recruitingPhase 1

A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura

Amgen Inc.0 sites210 target enrollmentStarted: March 21, 2007Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
210

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • - Subject is = 18 years of age.
  • - Subject has a diagnosis of ITP according to ASH guidelines.
  • - If subject is > 60 years of age, subject has a written bone marrow biopsy report confirming the diagnosis of ITP.
  • - Subject has received at least 1 prior therapy for ITP.
  • - Subject has a platelet count < 50 x 109/L or their platelet count falls to < 50 x 109/L during or after a clinically- indicated taper or discontinuation of current ITP therapy.
  • - Before any study- specific procedure, the appropriate written informed consent must be obtained (see Section 12.1).
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • - Subject has had a splenectomy for any reason.
  • - Subject has an active malignancy.
  • - Subject has a history of cancer, other than basal cell carcinoma or cervical carcinoma in situ, with treatment or active disease within 5 years.
  • - Subject has a known history of bone marrow stem cell disorder,
  • Abnormal bone marrow findings, other than those typical of ITP, must be approved by Amgen before a subject may be enrolled in the study.
  • - Subject has participated in any study evaluating PEG- rHuMGDF, recombinant human thrombopoietin (rHuTPO), AMG 531, or a thrombopoietic protein.
  • - Subject is receiving other investigational agents or procedures.
  • - Subject is currently enrolled in, or has completed within the last 30 days, another investigational device or drug study.
  • - Subject is pregnant or breast feeding.
  • - Subject is not using adequate contraceptive precautions.
  • - Subject has known sensitivity to any recombinant E coli- derived product.
  • - Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and does not have a legally acceptable representative.
  • - Subject has any kind of disorder that compromises the ability of the subject to comply with study procedures.

Investigators

Sponsor
Amgen Inc.

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