Evaluation of the effect of Imatinib on painful crisis of Patients with sickle cell anemia
Design
Phase 1 and 2 study on 10 patients and evaluation of the before and after effects of the drug
Settings and conduct
This study will conducted on patients with severe refractory sickle cell anemia in hematology clinics of Shiraz University of Medical Science. The patients will be entered the study for one year after obtaining informed consent and explanations about Imatinib and it's possible side effects.
The patients will be excluded from the study if they do not tolerate the drug, declare dissatisfaction or show side effects.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with severe sickle cell anemia unresposive to hydroxyurea.
exclusion criteria: allergy to imatinib or addiction
Intervention groups
Intervention group: Prescription of Imatinib, made by Osveh, to patients with refractory sickle cell anemia , 100 mg 3 times per day and evaluation of the beneficial or untoward effect of it. Study duration is about one year.
Main outcome variables
Number of painful crisis per year in each patient, Total number of hospitalization due to painful crisis per year per patient
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131106015305N2
Registration date:2020-12-01, 1399/09/11
Registration timing:retrospective
Last update:2020-12-01, 1399/09/11
Update count:0
Registration date
2020-12-01, 1399/09/11
Registrant information
Name
Mojtaba Karimi
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1623 2937
Email address
mjkarimi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2015-04-05, 1394/01/16
Actual recruitment start date
2014-04-05, 1393/01/16
Actual recruitment end date
2014-09-23, 1393/07/01
Trial completion date
2020-03-20, 1399/01/01
Scientific title
Impact of imatinib on reducing the painful crisis in patients with sickle cell disease
Public title
Impact of imatinib on reducing the painful crisis in patients with sickle cell disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with sickle cell syndromes
have at least 3 painful crisis or more per year despite adhearence to their standard treatment i.e. hydroxyurea
Exclusion criteria:
allergy to imatinib
addiction to opiods
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
10
Actual sample size reached:
8
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2014-07-28, 1393/05/06
Ethics committee reference number
IR.SUMS.REC.1393.4092
Health conditions studied
1
Description of health condition studied
Sickle cell anemia
ICD-10 code
D57
ICD-10 code description
Sickle-cell disorders
Primary outcomes
1
Description
Number of painful crisis per year in each patient
Timepoint
Before intervention and every 1 month for a year
Method of measurement
Patients self report, Hospitalization record, The amount of analgesic used per month in each patient
2
Description
Total number of hospitalization due to painful crisis per year per patient
Timepoint
Before study and then every 1 months for 1 years
Method of measurement
Patients self report, Hospitalization record
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Administration of Imatinib, made by Osveh, 100mg three times per day , to continue for one year
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Mojtaba Karimi
Street address
Namazi hospital, Zand square
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4301
Email
mjkarimi@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Abbas Rezaianzadeh
Street address
Research deputy, Shiraz University of Medical Sciences, Zand Blvd