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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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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2005-002274-30-GB |
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Date of registration:
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04/11/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to assess the safety, efficacy and tolerability of Rituximab(Mabthera) in combination with Plasma Exchange in patients with Acute Thrombotic Thrombocytopenia Purpura. - The use of Rituximab in Acute Thrombotic Thrombocytopenic Purpura.
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Scientific title:
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A Study to assess the safety, efficacy and tolerability of Rituximab(Mabthera) in combination with Plasma Exchange in patients with Acute Thrombotic Thrombocytopenia Purpura. - The use of Rituximab in Acute Thrombotic Thrombocytopenic Purpura. |
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Date of first enrolment:
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14/12/2005 |
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Target sample size:
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40 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002274-30 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: no
Open: yes
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III):
Therapeutic use (Phase IV):
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
-Patients >18 years and < 65 years who present with an acute episode of TTP.
-Evidence of microangiopathic haemolytic anaemia.
-Thrombocytopenia with a normal clotting screen.
-Raised lactate dehydrogenase (one and a half times above upper normal).
-Patients without neurological dysfunction able to give informed consent.
-Patients of reproductive age [must avoid pregnancy for 12 months and or normalised B cell function after receiving Rituximab. Oestrogen containing oral contraceptive pills and the morning after pills should be avoided in female TTP patients].
-Patients with an acute deterioration in neurological function which may include encephalopathy, such as altered personality, problems with short term memory and coma can be included when consent has been given by next of kin or from the appropriate legal representative.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
-All female subjects who are knowingly pregnant or breast feeding or do not use an adequate form of contraception [the effects on the foetus and newborn have not yet been fully established so Rituximab should be avoided in these groups. Male patients receiving Rituximab should ensure adequate contraception for 12 months following treatment.]
-Patients who are HIV positive [which does not appear to be antibody mediated, would be unlikely to benefit from Rituximab].
-Patients with childhood TTP.
-Patients who have haemolytic uraemic syndrome [which is not associated with reduced ADAMTS 13 levels].
-Patients who are Post bone marrow transplant-either autologous or allogeneic
-Patients with a medical or long term psychiatric condition which, in the opinion of the investigator, contraindicates the patients’ participation into the trial.
-Previous or concurrent malignancies at other sites, with exception of appropriately treated localized epithelial or cervical cancer. Patients with a history of cured tumours may be entered (> 5 years).
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Thrombotic Thrombocytopenia Purpura
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Intervention(s)
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Trade Name: MabThera
Product Name: MabThera
Product Code: IDEC-C2B8, Ro 45-2294
Pharmaceutical Form: Concentrate for solution for infusion
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Primary Outcome(s)
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Main Objective: Time to remission as defined by days until sustained platelet count>150 X 109/L, normal lactate dehydrogenase and number of plasma exchanges required, as defined by No of procedures per admission compared to historical controls.
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Primary end point(s): Time to remission as defined by days until sustained platelet count>150 X 109/L, normal lactate dehydrogenase and number of plasma exchanges required.
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Secondary Objective: - Improved mortality of TTP patients (assessed at 3 months from presentation)
- Safety and toxicity of Rituximab in conjunction with standard therapy for acute TTP
- Effect of Rituximab on B lymphocyte function
- Effect of Rituximab on ADAMTS 13 activity and antibody production and time to relapse
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Secondary ID(s)
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BRD/05/11
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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