A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.
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.
1 other identifier
interventional
122
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2007
Typical duration for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 17, 2007
CompletedFirst Posted
Study publicly available on registry
May 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
February 23, 2015
CompletedFebruary 23, 2015
February 1, 2015
4.3 years
May 17, 2007
October 6, 2014
February 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR)
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.
Week 8
Secondary Outcomes (17)
Percentage of Participants With Hematological CR, PR, or Minor Response (MR)
Week 8
Percentage of Participants Who Achieved CR
Week 52
Time to CR
Baseline to Week 52
Percentage of Participants Who Achieved PR
Week 52
Time to PR
Baseline to Week 52
- +12 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- refractory, relapsing or chronic idiopathic thrombocytopenic purpura;
- stable therapy during 3 weeks prior to study entry.
You may not qualify if:
- newly diagnosed ITP (\<6 weeks);
- prior treatment with MabThera;
- active bleeding requiring platelet transfusion within 7 days prior to entry into study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Unknown Facility
Adelaide, New South Wales, 5011, Australia
Unknown Facility
Gosford, New South Wales, 2250, Australia
Unknown Facility
Randwick, New South Wales, NSW 2031, Australia
Unknown Facility
Sydney, New South Wales, 2139, Australia
Unknown Facility
Sydney, New South Wales, 2747, Australia
Unknown Facility
Westmead, New South Wales, 2145, Australia
Unknown Facility
Woolloongabba, Queensland, 4102, Australia
Unknown Facility
Adelaide, South Australia, 5042, Australia
Unknown Facility
Frankston, Victoria, 3199, Australia
Unknown Facility
Malvern, Victoria, 3144, Australia
Unknown Facility
Melbourne, Victoria, 3168, Australia
Unknown Facility
Parkville, Victoria, 3052, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2007
First Posted
May 21, 2007
Study Start
May 1, 2007
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
February 23, 2015
Results First Posted
February 23, 2015
Record last verified: 2015-02