To evaluate the effect of thalidomide on hemoglobin levels in patients with thalassemia intermedia who are dependent on blood transfusions and have not responded favorably to hydroxyurea treatment
Design
The study includes only an intervention group.
No blinding is applied.
Conducted in Phase 2.
Performed on 50 patients.
Randomization is not required.
Settings and conduct
This is a single-center and interventional study.
Conducted at Shahid Baghaei 2 Hospital.
Patients meeting the inclusion criteria will receive thalidomide and aspirin after visiting the medical center.
Patient follow-ups will be conducted at regular intervals over an 8-week period.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Visiting the Baghaei 2 Medical Center and having a medical record there
Dependency on blood transfusions
Lack of a favorable response to hydroxyurea treatment
Age over 18 years
Baseline hemoglobin level of less than 10
Signing the informed consent form
Exclusion Criteria:
History of hypersensitivity reaction to thalidomide
Pregnancy or breastfeeding
Intervention groups
Patients with thalassemia intermedia who visit the Shahid Baghaei 2 Hospital Medical Center.
Main outcome variables
Change in hemoglobin levels before and after the intervention (at the end of 8 weeks)
Blood transfusion requirement before and after the intervention
Adverse effects related to thalidomide use
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180603039959N5
Registration date:2025-02-15, 1403/11/27
Registration timing:prospective
Last update:2025-02-15, 1403/11/27
Update count:0
Registration date
2025-02-15, 1403/11/27
Registrant information
Name
bijan keikhaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3375 0410
Email address
keikhaeib@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-28, 1403/12/10
Expected recruitment end date
2025-05-31, 1404/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effects of Thalidomide on Hemoglobin Levels in Patients with Thalassemia Intermedia: A Clinical trial
Public title
Thalidomide in Thalassemia Intermedia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Visiting the Baghaei 2 Medical Center and having a medical record there
Dependency on blood transfusions
Lack of a favorable response to hydroxyurea treatment
Age over 18 years
Baseline hemoglobin level of less than 10
Signing the informed consent form
Exclusion criteria:
History of hypersensitivity reaction to thalidomide
Pregnancy or breastfeeding
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
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
کارگروه/ کمیته اخلاق در پژوهش دانشگاه علوم پزشکی جندی شاپور اهواز
Street address
Farvardin Blvd, Golestan region
City
Ahvaz
Province
Khouzestan
Postal code
6138933333
Approval date
2025-01-18, 1403/10/29
Ethics committee reference number
IR.AJUMS.REC.1403.560
Health conditions studied
1
Description of health condition studied
thalassemia intermedia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Hemoglobin
Timepoint
Before starting the medication and at the end of 8 weeks
Method of measurement
Hemoglobin level will be measured using a complete blood count (CBC) test with a hematology analyzer.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Baghaei 2 Hospital
Full name of responsible person
Bijan Keikhaei Dehdezi
Street address
Golestan BLV
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3375 0410
Email
keikhaeib@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
عبدالله رفیعی
Street address
Golestan blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Fax
+98 61 3373 8294
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Daryush Purrahman
Position
research asistant
Latest degree
Master
Other areas of specialty/work
Hematology
Street address
Golestan blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3375 0410
Email
daryushpurrahman@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Daryush Purrahman
Position
Research assistant
Latest degree
Master
Other areas of specialty/work
Hematology
Street address
Golestan blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3375 0410
Fax
Email
daryushpurrahman@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Daryush Purrahman
Position
Research assistant
Latest degree
Master
Other areas of specialty/work
Hematology
Street address
Golestan blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3375 0410
Fax
Email
daryushpurrahman@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to concerns regarding patient privacy and ethical considerations, individual patient data (IPD) will not be shared. Additionally, data sharing may require legal permissions and compliance with data protection regulations.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available