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

• Conditions: Immune (idiopathic) thrombocytopenic purpura (ITP); MedDRA version: 8.1Level: PTClassification code 10021245Term: Idiopathic thrombocytopenic purpura

• Registration Number: EUCTR2006-003700-18-NL
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified