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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12607000297426 |
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Date of registration:
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04/06/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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16/05/2007 |
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Target sample size:
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108 |
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Recruitment status: |
Recruiting |
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URL:
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https://anzctr.org.au/ACTRN12607000297426.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
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Phase:
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Countries of recruitment
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Australia
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Contacts
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Name:
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James Scott
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Address:
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Roche Products
4-10 Inman Road Dee Why NSW 2099
Australia |
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Telephone:
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+61 2 9454 9242 |
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Email:
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james_c.scott@roche.com |
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Affiliation:
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Name:
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James Scott
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Address:
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Roche Products
4-10 Inman Road Dee Why NSW 2099
Australia |
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Telephone:
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+61 2 9454 9242 |
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Email:
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james_c.scott@roche.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
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).
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Idopathic Thrombocytopenic Purpura;
Idopathic Thrombocytopenic Purpura
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Blood - Other blood disorders
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Intervention(s)
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Only one treatment, rituximab fixed dose of 1000 mg on day 1 and 15 given intravenously (IV).
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Primary Outcome(s)
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Response rate based on platelet count as determined by blood tests (full blood count).[Measured 8 weeks after day 1.]
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Secondary Outcome(s)
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Duration of response[Measured monthly from week 8 up to 52 weeks.]
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Safety [As reported by patients at weekly study visits up to week 8]
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Secondary ID(s)
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ClinicalTrials.gov: NCT00475423
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Source(s) of Monetary Support
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Roche
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Ethics review
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Status: Not approved
Approval date:
Contact:
Frankston Hospital.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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