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

• Register: EUCTR
• Last refreshed on: 29 May 2012
• Main ID: EUCTR2004-000174-31-ES
• Date of registration: 26/04/2006
• Prospective Registration: No
• Primary sponsor: Amgen Inc
• Public title: A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy
• Scientific title: A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy
• Date of first enrolment: 16/05/2005
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000174-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1.Diagnosis of ITP according to American Society of Hematology (ASH) guidelines
2.Have had a splenectomy for the treatment for ITP = 24 weeks prior to study entry
3.Subjects > 60 years of age must have a documented history of chronic ITP with a bone marrow report to confirm the diagnosis
4.The platelet count (calculated from the mean of the 2 counts taken during the screening and pre-treatment periods) must be:
less than or equal to 30 x 109/L for those subjects not receiving any ITP therapy
less than or equal to 50 x 109/L for those subjects receiving a constant dose schedule (no adjustment for 4 weeks) of corticosteroids, azathioprine, or danazol
5.Subjects must be more 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 to2 mg/dl (less than or equal to 176.8 mcmol/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 > 11.0 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..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)
2.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
3.Currently receiving any treatment for ITP except corticosteroids, azathioprine, or danazol administered at a constant dose and schedule
4.IV Ig or anti-D Ig within 2 weeks before the screening visit
5.Rituximab (for any indication) within 14 weeks before the screening visit or anticipated use during the time of the proposed study
6.Received hematopoietic growth factors, including IL-11 (oprelvekin) within 4 weeks before the screening visit
7.Received any alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study
8.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 other investigational agent(s)
9.Past or present participation in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), AMG 531, or related platelet product
10.Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding
11.Subject is not using adequate contraceptive precautions
12.Known hypersensitivity to any recombinant E coli -derived product
13.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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP)

Intervention(s)

Product Name: AMG 531
Product Code: AMG 531
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: AMG 531
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: To evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP refractory to splenectomy as measured by the platelet response

Secondary Objective: 1.To evaluate the overall safety of AMG 531

2.To evaluate possible reductions in the dose of concurrent ITP therapies while receiving AMG 531

3.To evaluate changes in Patient Reported Outcomes (PRO) and Health Resource Utilization (HRU) due to treatment with AMG 531

Primary end point(s): The primary endpoint is the incidence of platelet response defined as the proportion of subjects achieving a platelet count double the baseline and greater than or equal to 50 x109/L in the absence of rescue medication during the treatment period.

Secondary ID(s)

20030105

2004-000174-31-GB