Clinical trial NCT00475423: A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Thrombocytopenic Purpura
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-05-21
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* refractory, relapsing or chronic idiopathic thrombocytopenic purpura;
* stable therapy during 3 weeks prior to study entry.

Exclusion Criteria:

* newly diagnosed ITP (\<6 weeks);
* prior treatment with MabThera;
* active bleeding requiring platelet transfusion within 7 days prior to entry into study.

Primary outcomes:
measure: Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR)
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of Participants With Hematological CR, PR, or Minor Response (MR)
timeFrame: Week 8
measure: Percentage of Participants Who Achieved CR
timeFrame: Week 52
measure: Time to CR
timeFrame: Baseline to Week 52
measure: Percentage of Participants Who Achieved PR
timeFrame: Week 52
measure: Time to PR
timeFrame: Baseline to Week 52
measure: Percentage of Participants Who Achieved MR
timeFrame: Week 52
measure: Time to MR
timeFrame: Baseline to Week 52
measure: Percentage of Participants With Continued CR From Week 8 to Week 52
timeFrame: Week 8 to Week 52
measure: Duration of CR in Participants With Continued CR From Week 8 Until Week 52
timeFrame: Week 8 to Week 52
measure: Duration of PR in Participants With Continued PR From Week 8 Until Week 52
timeFrame: Week 8 to Week 52
measure: Duration of MR in Participants With Continued MR From Week 8 Until Week 52
timeFrame: Week 8 to Week 52
measure: Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event
timeFrame: Week 52
measure: Time to Initiation of New ITP Therapy
timeFrame: Baseline to Week 52
measure: Percentage of Therapeutic Responders
timeFrame: Week 26 and Week 52
measure: Percentage of Participants With a Therapeutic Response
timeFrame: Week 26 and Week 52
measure: Cluster of Differentiation 19 (CD19) B Cell Count
timeFrame: Baseline, Weeks 1, 3, and 8, Follow-up Months 4, 6, 8, 10, and 12, and Last Day
measure: Change From Baseline in CD19 B Cell Count
timeFrame: Weeks 3, 8 and Months 4, 6, 8, 10 and 12, and last day
Other outcomes:
Locations:
city: Adelaide
country: Australia
state: New South Wales
city: Gosford
country: Australia
state: New South Wales
city: Randwick
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Westmead
country: Australia
state: New South Wales
city: Woolloongabba
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Frankston
country: Australia
state: Victoria
city: Malvern
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: