| CTRI Number |
CTRI/2020/05/024976 [Registered on: 01/05/2020] Trial Registered Prospectively |
| Last Modified On: |
29/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Optimizing the role of Thiopurines therapy in Inflammatory Bowel Disease |
|
Scientific Title of Study
|
Thiopurines therapy in Inflammatory Bowel Disease: Role of a spectrum of metabolites and enzymes in predicting the response |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shailesh |
| Designation |
Research Scholar |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education |
| Address |
Deapartment of Gastroenterology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7406985507 |
| Fax |
|
| Email |
shailesh.kmc@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Pai C |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education |
| Address |
Deapartment of Gastroenterology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7406985507 |
| Fax |
|
| Email |
cgpai@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Shailesh |
| Designation |
Research Scholar |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education |
| Address |
Deapartment of Gastroenterology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7406985507 |
| Fax |
|
| Email |
shailesh.kmc@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Mahdhav Nagar, Manipal 576104, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Shailesh |
| Address |
Department of Gastroenterology, Kasturba Medical College, Manipal |
| Type of Sponsor |
Other [Investigator Initiated] |
|
|
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 |
| Shailesh |
Kasturba Hospital (KMC), Manipal |
Department of Gastroenterology, 4th Floor, Smt.Sharada Madhav Pai OPD, Kasturba Hospital (KMC), Manipal
Udupi
KARNATAKA |
08202922192
shailesh.kmc@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospitl Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K50-K52||Noninfective enteritis and colitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with a definite diagnosis of Ulcerative Colitis (UC) or Crohn’s Disease (CD) being initiated on azathioprine/6-mercaptopurine/ 6Tioguanine therapy (designated as thiopurine (TP) therapy) as per standard accepted criteria will be included. |
|
| ExclusionCriteria |
| Details |
1. Patients with CD or UC on biologicals, or immunosuppressives other than thiopurines
2. Subjects who have undergone total procto-coloctomy for UC
3. Evidence of colorectal dysplasia or malignancies
4. Patients in whom bowel surgery appears to be imminent
5. Congenital or acquired immunodeficiency, especially known HIV infections, or evidence
of other immuno-compromised states
6. Patients ineligible in any way for TP therapy e. g. known intolerance to the drug
7. Patients not providing written informed consent for inclusion
8. Planning to conceive in 17weeks after initiation of therapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Quantifying Thiopurine metabolites,TPMT,IMPDH,ITPase,HGPRT enzymes using LC-MS/MS
2. Comparision of the metabloites and Enzyme levels in Responders and Non Responders |
All at the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Quantifying Thiopurine metabolites,TPMT,IMPDH,ITPase,HGPRT enzymes using LC-MS/MS |
After the initiation of the Therapy |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The overall aim of this project is to make use of the spectrum of
metabolite profiles, the activity and concentrations of TPMT, ITPase, HGPRT and
IMPDH in IBD patients on TP therapy in order to optimize therapy and predict
responders from non-responders, thus translating basic research to efficient,
cost-effective patient care applicable in developing low-income countries. |