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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2004-000174-31-GB |
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Date of registration:
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25/02/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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07/04/2005 |
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Target sample size:
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60 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000174-31 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Spain
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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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 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 more than or equal to 18 years of age at the time of obtaining th e informed consent
6. A serum creatinine concentration less than or equal to2 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..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
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Health Condition(s) or Problem(s) studied
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Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP)
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Intervention(s)
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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
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Primary Outcome(s)
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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
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Primary end point(s): The primary endpoint is the incidence of durable platelet response. A subject with durable platelet response is defined as achieving at least 6 weekly platelet responses during the last 8 weeks of treatment in the absence of rescue medication. A weekly platelet response is defined as a platelet count of = 50 x 109/L on the weekly scheduled dose day from week 2 to week 25.
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Main Objective: The primary objective of this study is to evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP refractory to splenectomy as measured by the durable platelet response during the last 8 weeks of treatment and other platelet response parameters.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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