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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00475423
Registration number
NCT00475423
Ethics application status
Date submitted
17/05/2007
Date registered
21/05/2007
Date last updated
23/02/2015
Titles & IDs
Public title
A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.
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Scientific title
An Open Label Study of a Fixed Dose Regimen of MabThera on Overall Response Rate in Patients With Refractory, Relapsing or Chronic Idiopathic Thrombocytopenic Purpura.
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Secondary ID [1]
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ML20948
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Thrombocytopenic Purpura
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Condition category
Condition code
Inflammatory and Immune System
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Autoimmune diseases
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Blood
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - rituximab [MabThera/Rituxan]
Experimental: 1 -
Treatment: Drugs: rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR)
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Assessment method [1]
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Percentage of participants with an overall response at Week 8 achieving a CR or PR as evaluated by platelets, new or increased Idiopathic Thrombocytopenic Purpura (ITP)-related treatments and corticosteroids given for Adverse Events (AEs). CR was defined as a platelet count of greater than (>) 150x10^9/ liters (L) over at least 2 consecutive measurements at least 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. PR was defined as platelet count of >50x10^9/L over at least 2 consecutive measurements at least <2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Overall response rate (participants who achieved CR or confirmed PR) was evaluated using platelets, new or increased ITP related treatments, and corticosteroids given for AEs.
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Timepoint [1]
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Week 8
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Secondary outcome [1]
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Percentage of Participants With Hematological CR, PR, or Minor Response (MR)
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Assessment method [1]
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Percentage of participants with CR, PR, and MR at Week 8 as evaluated by platelet count where CR is greater than or equal to (=)150x10^9/L, PR = 50x10^9/L, MR equals (=) 30x10^9/L over 2 consecutive measurements at least 2 weeks apart but no more than 60 days apart with no increase in concomitant therapy or initiation of new ITP therapy.
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Timepoint [1]
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Week 8
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Secondary outcome [2]
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Percentage of Participants Who Achieved CR
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Assessment method [2]
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CR was defined as platelet counts >150x10^9/L over =2 consecutive measurements =2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
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Timepoint [2]
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Week 52
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Secondary outcome [3]
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Time to CR
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Assessment method [3]
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Time to CR was defined as the time from the first infusion to the first date on which CR was achieved. CR was defined as platelet counts >150x10^9/L over =2 consecutive measurements =2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants without an event were censored at the date of last assessment.
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Timepoint [3]
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Baseline to Week 52
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Secondary outcome [4]
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Percentage of Participants Who Achieved PR
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Assessment method [4]
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PR was defined as platelet counts >50x10^9/L over =2 consecutive measurements =2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
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Timepoint [4]
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Week 52
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Secondary outcome [5]
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Time to PR
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Assessment method [5]
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Time to response was defined as the time from the first infusion to the first date on which PR was achieved. PR was defined as platelet counts > 50x10^9/L over = 2 consecutive measurements = 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
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Timepoint [5]
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Baseline to Week 52
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Secondary outcome [6]
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Percentage of Participants Who Achieved MR
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Assessment method [6]
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MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over =2 consecutive measurements =2 weeks apart, but no more than 60 days apart, with a 50 to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
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Timepoint [6]
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Week 52
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Secondary outcome [7]
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Time to MR
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Assessment method [7]
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Time to response was defined as the time from the first infusion to the first date on which MR was achieved. MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over =2 consecutive measurements =2 weeks apart, but no more than 60 days apart, with a 50 percent (%) to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
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Timepoint [7]
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Baseline to Week 52
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Secondary outcome [8]
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Percentage of Participants With Continued CR From Week 8 to Week 52
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Assessment method [8]
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The number of participants with a durable CR assessed in CR responders whose responses were sustained from Week 8 through to the end of the study or withdrawal, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over =2 consecutive measurements = 2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
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Timepoint [8]
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Week 8 to Week 52
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Secondary outcome [9]
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Duration of CR in Participants With Continued CR From Week 8 Until Week 52
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Assessment method [9]
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Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of CR, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over =2 consecutive measurements =2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
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Timepoint [9]
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Week 8 to Week 52
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Secondary outcome [10]
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Duration of PR in Participants With Continued PR From Week 8 Until Week 52
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Assessment method [10]
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Duration of PR was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of PR, irrespective of change of treatment. PR was defined as platelet counts >50x10^9/L over =2 consecutive measurements =2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.
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Timepoint [10]
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Week 8 to Week 52
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Secondary outcome [11]
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Duration of MR in Participants With Continued MR From Week 8 Until Week 52
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Assessment method [11]
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Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of MR, irrespective of change of treatment. MR was defined as participants registered with ITP in relapse with a platelet count of > 30x10^9/L over =2 consecutive measurements =2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants registered with chronic ITP with a platelet count of >30x10^9/L over =2 consecutive measurements =2 weeks apart, but no more than 60 days apart, with a 50% to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.
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Timepoint [11]
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Week 8 to Week 52
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Secondary outcome [12]
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Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event
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Assessment method [12]
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Percentage of participants with an event of initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.
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Timepoint [12]
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Week 52
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Secondary outcome [13]
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Time to Initiation of New ITP Therapy
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Assessment method [13]
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Median time in days to initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.
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Timepoint [13]
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Baseline to Week 52
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Secondary outcome [14]
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Percentage of Therapeutic Responders
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Assessment method [14]
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Percentage of participants with a therapeutic response, defined as achieving CR, PR, or MR assessed at Week 26 and Week 52 or hematological response, defined as achieving CR, PR, or MR at Week 8. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR response was defined as at least a minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least a minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.
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Timepoint [14]
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Week 26 and Week 52
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Secondary outcome [15]
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Percentage of Participants With a Therapeutic Response
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Assessment method [15]
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Number of therapeutic responder participants by CR, PR, MR, or no response (NR) measured at Week 26 and Week 52. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR was defined as at least minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.
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Timepoint [15]
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Week 26 and Week 52
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Secondary outcome [16]
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Cluster of Differentiation 19 (CD19) B Cell Count
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Assessment method [16]
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Value of mean CD19+ B cell count at baseline. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L.
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Timepoint [16]
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Baseline, Weeks 1, 3, and 8, Follow-up Months 4, 6, 8, 10, and 12, and Last Day
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Secondary outcome [17]
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Change From Baseline in CD19 B Cell Count
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Assessment method [17]
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Actual values of CD19+ mean B cell count assessed at Weeks 3 and 8, and Months 4, 6, 8, 10 and 12, and last day. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L.
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Timepoint [17]
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Weeks 3, 8 and Months 4, 6, 8, 10 and 12, and last day
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Eligibility
Key inclusion criteria
- adult patients, >=18 years of age;
- refractory, relapsing or chronic idiopathic thrombocytopenic purpura;
- stable therapy during 3 weeks prior to study entry.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- newly diagnosed ITP (<6 weeks);
- prior treatment with MabThera;
- active bleeding requiring platelet transfusion within 7 days prior to entry into
study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2011
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Sample size
Target
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Accrual to date
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Final
122
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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- Adelaide
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Recruitment hospital [2]
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- Gosford
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Recruitment hospital [3]
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- Randwick
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Recruitment hospital [4]
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- Sydney
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Recruitment hospital [5]
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- Westmead
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Recruitment hospital [6]
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- Woolloongabba
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Recruitment hospital [7]
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- Frankston
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Recruitment hospital [8]
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- Malvern
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Recruitment hospital [9]
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- Melbourne
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Recruitment hospital [10]
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- Parkville
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Recruitment postcode(s) [1]
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5011 - Adelaide
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Recruitment postcode(s) [2]
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2250 - Gosford
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Recruitment postcode(s) [3]
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NSW 2031 - Randwick
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Recruitment postcode(s) [4]
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2139 - Sydney
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Recruitment postcode(s) [5]
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2747 - Sydney
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Recruitment postcode(s) [6]
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2145 - Westmead
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Recruitment postcode(s) [7]
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4102 - Woolloongabba
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Recruitment postcode(s) [8]
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5042 - Adelaide
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Recruitment postcode(s) [9]
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3199 - Frankston
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Recruitment postcode(s) [10]
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3144 - Malvern
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Recruitment postcode(s) [11]
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3168 - Melbourne
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Recruitment postcode(s) [12]
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3052 - Parkville
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This single arm study will evaluate the efficacy and safety of MabThera monotherapy in
patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura (ITP).
Patients will receive infusions of MabThera 1000mg i.v. on days 1 and 15. The anticipated
time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00475423
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00475423
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