| CTRI Number |
CTRI/2019/07/020354 [Registered on: 24/07/2019] Trial Registered Prospectively |
| Last Modified On: |
11/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to evaluate some genetic basis for azathioprine drug induced leukopenia |
|
Scientific Title of Study
|
A case control trial to assess association of TPMT(Thiopurine methyltransferase)and NUDT15(Nudix hydrolase)gene polymorphisms with azathioprine induced leukopenia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUPARNA CHATTERJEE |
| Designation |
Professor |
| Affiliation |
IPGME&R and SSKM hospital,Kolkata |
| Address |
Dept of Pharmacology
Institute of Postgraduate Medical Education and Research
244B AJC Bose Road
Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
03322041428 |
| Fax |
|
| Email |
drsupchat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUPARNA CHATTERJEE |
| Designation |
Professor |
| Affiliation |
IPGME&R and SSKM hospital,Kolkata |
| Address |
Dept of Pharmacology
Institute of Postgraduate Medical Education and Research
244B AJC Bose Road
Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
03322041428 |
| Fax |
|
| Email |
drsupchat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUPARNA CHATTERJEE |
| Designation |
Professor |
| Affiliation |
IPGME&R and SSKM hospital,Kolkata |
| Address |
Dept of Pharmacology
Institute of Postgraduate Medical Education and Research
244B AJC Bose Road
Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
03322041428 |
| Fax |
|
| Email |
drsupchat@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGME&R and SSKM Hospital |
|
|
Primary Sponsor
|
| Name |
IPGMER and SSKM Hospital |
| Address |
Dept of Pharmacology
Institute of Postgraduate Medical Education and Research
244B AJC Bose Road
Kolkata |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhijnan Ghosh |
IPGMER and SSKM Hospital Kolkata |
Department of Pharmacology, 1st floor UCM building, IPGME&R and SSKM Hospital, 244 AJC Bose Road Kolkata
Kolkata
WEST BENGAL |
7003466065
dr.abhijnan@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research OversightCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M04||Autoinflammatory syndromes, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Cases: Adult patients of either gender with a clinical diagnosis of an autoimmune disorder on azathioprine
Subjects on azathioprine who developed leukopenia within one year of treatment initiation that necessitated reduction of dose or drug withdrawal
Subjects should be willing to give written informed consent regarding study participation
Controls shall fulfill all inclusion and exclusion criteria except the occurrence of incidents of leukopenia. They will be age,gender and ethnicity matched. |
|
| ExclusionCriteria |
| Details |
History of moderate to severe leukopenia in the past
History of intake of any drugs that it likely to have effect on haematopoietic stem cells
History of leukaemia, lymphoma, myelodysplastic syndorme, |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
TPMT gene polymorphisms c238G to C c460G to A and c719A to G
and NUDT15 polymorphism c415C to T |
within 1 week of enrollment DNA extraction will be done |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of TPMT and NUDT15 gene polymorphisms |
at outcome |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/08/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Case control study to assess the association of TPMT and NUDT15 gene polymorphisms with azathioprine induced leukopenia in adult patients (18-60 years) suffering from autoimmune diseases. Azathioprine is a commonly used immunosuppressant with a low therapeutic index. Leukopenia is the most common adverse effect which necessitates dose reduction or drug withdrawal. Studies have suggested a genetic basis for this adverse effect but reports are inconclusive. Studies suggest it is linked with polymorphism of the gene encoding for thiopurine methyltransferase (TPMT) enzyme which is involved in azathioprine metabolism while other studies have refuted it. Recent reportys also suggest that it may be linked to NUDT15(Nudix hydrolase 15) gene polymorphism. Since there are no published studies in eastern Indian population in this area, this study is planned. |