A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy

Phase 1

• Conditions: Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP)

• Registration Number: EUCTR2004-000173-65-GB
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-25
• Study Completion: 2006-12-21
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1.·Diagnosis of ITP according to American Society of Hematology (ASH) guidelines at least 3 months before enrollment
2. Have completed at least 1 prior treatment for ITP (eg, prednisone)
3. Subjects > 60 years of age must have a minimum of one year documented history of chronic ITP with a bone marrow report to confirm the diagnosis
4. The mean of the three platelet counts taken during the screening and pre-treatment periods must be = 30 x 109/L, with no individual count > 35 x 109/L
5. Subjects must be greater than or equal to 18 years of age at the time of obtaining the informed consent
6. A serum creatinine concentration less than or equal to 2 mg/dl (less than or equal to 176.8 mmol/L)
7. Adequate liver function, as evidenced by a serum bilirubin less than or equal to 1.5 times the laboratory normal range
8. Hemoglobin = 9.0 g/dL
9. Before any study-specific procedure, the appropriate written informed consent must be obtained

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

1. Have had a Splenectomy for any reason
2. Any known history of bone marrow stem cell disorder (Any abnormal bone marrow findings other than those typical of ITP must be approved by Amgen before a subject may be enrolled in the study)
3. Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years before randomization
4. Currently receiving any treatment for ITP, except corticosteroids, azathioprine, or danazol administered at a constant dose and schedule
5. IV Ig or anti-D Ig within 2 weeks before the screening visit
6. Rituximab (for any indication) within 14 weeks before the screening visit or anticipated use during the time of the proposed study
7. Received hematopoietic growth factors, including IL-11 (oprelvekin) within 4 weeks before the screening visit
8. Received any alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study
9. Subject is currently enrolled in or has not yet completed at least 4 weeks since ending other investigational device or drug trial(s), or subject is receiving investigational agent(s) other than AMG 531
10. Past or present participation in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), AMG 531, or related platelet product
11. Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding
12. Subject is not using adequate contraceptive precautions
13. Known hypersensitivity to any recombinant E coli -derived product
14. Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with all study procedures

Study & Design

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