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. - 20060131

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-003700-18-IT
• Date of registration: 09/05/2007
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc.
• Public title: 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. - 20060131
• Scientific title: 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. - 20060131
• Date of first enrolment: 22/06/2007
• Target sample size: 210
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003700-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Other specify the comparator: Trattamento Medico Standard

Countries of recruitment

Austria, Belgium, Czech Republic, France, Germany, Italy, Netherlands, Portugal, United Kingdom

Key inclusion & exclusion criteria

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
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 ? 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


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

Health Condition(s) or Problem(s) studied

Immune (idiopathic) thrombocytopenic purpura (ITP)
MedDRA version: 6.1 Level: PT Classification code 10021245

Intervention(s)

Product Name: AMG531
Pharmaceutical Form: Powder and solvent for suspension for injection
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Main Objective: The objective of the study is compare the ability of AMG 531 versus medical standard of care (SOC)to prevent a splenectomy and to provide a durable option for immune (idiopathic) thrombocytopenic purpura (ITO) non -splenectomized adult subjects during the 52- week treatment period

Primary end point(s): This study has 2 primary endpoints, one related to splenectomy and the other related to treatment failure. The first primary endpoint will be the number of subjects undergoing a splenectomy by treatment group during the 52-week treatment period. The second primary endpoint will be the number of subjects with a treatment failure during the 52-week treatment period.

Secondary Objective: The secondary objectives of the study are to observe the impact of AMG 531 on various ITP symptoms and platelet parameters compared to medical SOC for ITP. these include the time to splenoctomy, platelet response, and the change in ITP Patient Assessment Questionnaire (PAQ) Physical Helath domains of Symptoms, Bother, Activity and Fatigue.

Secondary ID(s)

2006-003700-18-AT

AMG 531 20060131