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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.
Register: EUCTR
Last refreshed on: 10 February 2014
Main ID:  EUCTR2010-018794-38-IT
Date of registration: 26/07/2010
Prospective Registration: Yes
Primary sponsor: FONDAZIONE IRCCS CA` GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
Public title: EVALUATION OF CLINICAL RESPONSE TO RITUXIMAB TREATMENT IN PATIENTS WITH ACQUIRED AUTOIMMUNE RECURRENT THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) - RITUXIMAB IN RECURRENT TTP
Scientific title: EVALUATION OF CLINICAL RESPONSE TO RITUXIMAB TREATMENT IN PATIENTS WITH ACQUIRED AUTOIMMUNE RECURRENT THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) - RITUXIMAB IN RECURRENT TTP
Date of first enrolment: 23/02/2010
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018794-38
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: TERAPIA STANDARD  
Phase: 
Countries of recruitment
Italy
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
-DIAGNOSIS OF ACQUIRED AUTOIMMUNE RECURRENT TTP
-AGE >18 YEARS
-CLINICAL REMISSION AT THE TIME OF ENROLMENT
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) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
-PREGNANCY
-ONGOING INFECTION
-SEVERE CARDIAC DISEASE
-HISTORY OF HYPERSENSITIVITY TO RITUXIMAB


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
THROMBOTIC THROMBOCYTOPENIC PURPURA
MedDRA version: 9.1 Level: LLT Classification code 10037562
Intervention(s)

Pharmaceutical Form: Concentrate for solution for injection
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: MABTHERA
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Rituximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)
Main Objective: PREVENTION OF DISEASE RECURRENCES
Primary end point(s): RECURRENCE RATE AT THREE YEARS
Secondary Objective: -INHIBITION OF ANTI-ADAMTS13 AUTOANTIBODIES
-CORRELATION OF ADAMTS13 ACTIVITY WITH CLINICAL RESPONSE
-CORRELATION OF LYMPHOCYTE DEPLETION AND CLINICAL RESPONSE
Secondary Outcome(s)
Secondary ID(s)
RTXTTP2010
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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