Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000297426
Ethics application status
Approved
Date submitted
22/05/2007
Date registered
4/06/2007
Date last updated
28/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A multi centre, open label study to evaluate efficacy and safety of 1000 mg of rituximab on day 1 and 15 in patients with idiopathic thrombocytopenic purpura
Scientific title
A multi centre, single arm, open label study to evaluate the efficacy and safety of 1000 mg fixed dose of rituximab on day one and fifteen among patients with chronic or relapsing idiopathic thrombocytopenic purpura
Secondary ID [1] 371 0
ClinicalTrials.gov: NCT00475423
Universal Trial Number (UTN)
Trial acronym
R-ITP 1000
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idopathic Thrombocytopenic Purpura 1839 0
Condition category
Condition code
Blood 1933 1933 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Only one treatment, rituximab fixed dose of 1000 mg on day 1 and 15 given intravenously (IV).
Intervention code [1] 1773 0
Treatment: Drugs
Comparator / control treatment
no comparator being used.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2748 0
Response rate based on platelet count as determined by blood tests (full blood count).
Timepoint [1] 2748 0
Measured 8 weeks after day 1.
Secondary outcome [1] 4639 0
Duration of response
Timepoint [1] 4639 0
Measured monthly from week 8 up to 52 weeks.
Secondary outcome [2] 4640 0
Safety
Timepoint [2] 4640 0
As reported by patients at weekly study visits up to week 8

Eligibility
Key inclusion criteria
Documented diagnosis of Idiopathic Thrombocytopaenic Purpura (ITP) according to the American Society of Haematology (ASH) guidelines:
1. Chronic ITP requiring ongoing corticosteroid and/or immunosuppressive therapy (e.g. dexamethasone, prednisolone, danazol, azathioprine and/or cyclophosphamide) for more than 3 months to maintain platelet count >30x10^9/L. Patients must have a documented platelet count of >30x10^9/L and = 50x10^9/L within 7 days prior to first infusion.

OR

2. ITP in relapse (> or = 1) (defined as a platelet count = 30x10^9/L), with first relapse occurring within 12 months of initial diagnosis and second relapse at any time thereafter. Patients must have a documented platelet count = 30x10^9/L and >10x10^9/L within 7 days prior to first infusion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. ITP diagnosed less than 6 weeks prior to consent.
2. Prior treatment with rituximab.
3. Multisystem autoimmune disease.
4. Lymphoproliferative disorders.
5. Drug-induced thrombocytopenia.
6. Pregnant or breast-feeding.
7. Human Immunodeficiency Virus (HIV) serology positive.
8. Hepatitis B or Hepatitis C serology positive (unless due to vaccination).

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
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
108
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2077 0
Commercial sector/Industry
Name [1] 2077 0
Roche
Country [1] 2077 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Roche
Address
4-10 Inman Road, Dee Why, NSW, 2099 Australia
Country
Australia
Secondary sponsor category [1] 1882 0
None
Name [1] 1882 0
not applicable
Address [1] 1882 0
Country [1] 1882 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3861 0
Frankston Hospital.
Ethics committee address [1] 3861 0
Ethics committee country [1] 3861 0
Australia
Date submitted for ethics approval [1] 3861 0
Approval date [1] 3861 0
Ethics approval number [1] 3861 0

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

Contacts
Principal investigator
Name 27876 0
Address 27876 0
Country 27876 0
Phone 27876 0
Fax 27876 0
Email 27876 0
Contact person for public queries
Name 10962 0
James Scott
Address 10962 0
Roche Products
4-10 Inman Road Dee Why NSW 2099
Country 10962 0
Australia
Phone 10962 0
+61 2 9454 9242
Fax 10962 0
Email 10962 0
[email protected]
Contact person for scientific queries
Name 1890 0
James Scott
Address 1890 0
Roche Products
4-10 Inman Road Dee Why NSW 2099
Country 1890 0
Australia
Phone 1890 0
+61 2 9454 9242
Fax 1890 0
Email 1890 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.