this clinical trial study was non randomize,single blind study without placebo in ten refractory TTP patients to plasma exchange at least seven days have been treated with plasma exchange and with a series of laboratory tests rule out secondary causes of ttp.informd written consents were obtaind then Patients treated with rituximab weekly for 4 weeks finally response rate(RR), Disease free survival (DFS) and overall survival( os) was evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012232125N1
Registration date:2017-07-25, 1396/05/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-25, 1396/05/03
Registrant information
Name
ali reza sadeghi
Name of organization / entity
esfahan university
Country
Iran (Islamic Republic of)
Phone
+98 31 3673 3910
Email address
a.sadeghi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
efficacy of rituximab in treatmeantof plasma exchange refractory TTP
Public title
the effect of rituximab in ttp patient refractory to plasmexchange
Purpose
Treatment
Inclusion/Exclusion criteria
exclusion:viral infection, malignancy,autoimmune disease,drug(cyclosporine,ticlopidine,..)
inclusion:criteria for ttp diagnosis
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
medical university of esfahan
Street address
medicah school hezar jarib avenue esfahan
City
esfahan
Postal code
Approval date
2012-11-21, 1391/09/01
Ethics committee reference number
391368
Health conditions studied
1
Description of health condition studied
TTP
ICD-10 code
D69
ICD-10 code description
.thrombotic thrombocytopenic purpura
Primary outcomes
1
Description
PLT-LDH
Timepoint
daily check to recieve to goal of treatmeant
Method of measurement
laboratory
Secondary outcomes
1
Description
BUN CR
Timepoint
at first daily check then weekly and monthly
Method of measurement
laboratory
2
Description
level of consciousness
Timepoint
at first daily check then weekly and monthly
Method of measurement
clinical examination
3
Description
drug complication
Timepoint
at first daily check then weekly and monthly
Method of measurement
clinical examination- laboratory
Intervention groups
1
Description
TTP patients that rule out secondary cause undergo treatmeant with monoclonal anti body (Rituximab) . this drug is anti CD20 ,marcker on the B Lymphocyte .
Rituximab dose was 375 mg/m2 weekly for 4 weeks.
Rituximab manufacture ROCH COMPANY
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
azahra hospital
Full name of responsible person
ali reza sadeghi
Street address
esfahan- sofe aven
City
esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research of esfahan university of medical sciences
Full name of responsible person
ali reza sadeghi
Street address
hezarjerib avenue esfahan iran
City
esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for research of esfahan university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
ESFAHAN UNIVERSITY OF MEDICINE
Full name of responsible person
ali reza sadeghi MD
Position
HEMATO ONCOLOGIST
Other areas of specialty/work
Street address
ESFSHAN
City
ESFAHAN
Postal code
81799-18946
Phone
+98 31 3673 3910
Fax
Email
sadeghi_hem@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
esfahan university medicine
Full name of responsible person
farzane ashrafy
Position
hemato - oncologist
Other areas of specialty/work
Street address
esfahan
City
esfahan
Postal code
Phone
00
Fax
Email
f_ashrafi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
sadeghi_hem@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)