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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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.
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.
Secondary ID [1] 0 0
ML20948
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Thrombocytopenic Purpura 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - rituximab [MabThera/Rituxan]

Experimental: 1 -


Treatment: Drugs: rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR)
Timepoint [1] 0 0
Week 8
Secondary outcome [1] 0 0
Percentage of Participants With Hematological CR, PR, or Minor Response (MR)
Timepoint [1] 0 0
Week 8
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved CR
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Time to CR
Timepoint [3] 0 0
Baseline to Week 52
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved PR
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Time to PR
Timepoint [5] 0 0
Baseline to Week 52
Secondary outcome [6] 0 0
Percentage of Participants Who Achieved MR
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Time to MR
Timepoint [7] 0 0
Baseline to Week 52
Secondary outcome [8] 0 0
Percentage of Participants With Continued CR From Week 8 to Week 52
Timepoint [8] 0 0
Week 8 to Week 52
Secondary outcome [9] 0 0
Duration of CR in Participants With Continued CR From Week 8 Until Week 52
Timepoint [9] 0 0
Week 8 to Week 52
Secondary outcome [10] 0 0
Duration of PR in Participants With Continued PR From Week 8 Until Week 52
Timepoint [10] 0 0
Week 8 to Week 52
Secondary outcome [11] 0 0
Duration of MR in Participants With Continued MR From Week 8 Until Week 52
Timepoint [11] 0 0
Week 8 to Week 52
Secondary outcome [12] 0 0
Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event
Timepoint [12] 0 0
Week 52
Secondary outcome [13] 0 0
Time to Initiation of New ITP Therapy
Timepoint [13] 0 0
Baseline to Week 52
Secondary outcome [14] 0 0
Percentage of Therapeutic Responders
Timepoint [14] 0 0
Week 26 and Week 52
Secondary outcome [15] 0 0
Percentage of Participants With a Therapeutic Response
Timepoint [15] 0 0
Week 26 and Week 52
Secondary outcome [16] 0 0
Cluster of Differentiation 19 (CD19) B Cell Count
Timepoint [16] 0 0
Baseline, Weeks 1, 3, and 8, Follow-up Months 4, 6, 8, 10, and 12, and Last Day
Secondary outcome [17] 0 0
Change From Baseline in CD19 B Cell Count
Timepoint [17] 0 0
Weeks 3, 8 and Months 4, 6, 8, 10 and 12, and last day

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
Accrual to date
Final
122
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Gosford
Recruitment hospital [3] 0 0
- Randwick
Recruitment hospital [4] 0 0
- Sydney
Recruitment hospital [5] 0 0
- Westmead
Recruitment hospital [6] 0 0
- Woolloongabba
Recruitment hospital [7] 0 0
- Frankston
Recruitment hospital [8] 0 0
- Malvern
Recruitment hospital [9] 0 0
- Melbourne
Recruitment hospital [10] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
NSW 2031 - Randwick
Recruitment postcode(s) [4] 0 0
2139 - Sydney
Recruitment postcode(s) [5] 0 0
2747 - Sydney
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5042 - Adelaide
Recruitment postcode(s) [9] 0 0
3199 - Frankston
Recruitment postcode(s) [10] 0 0
3144 - Malvern
Recruitment postcode(s) [11] 0 0
3168 - Melbourne
Recruitment postcode(s) [12] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00475423