| CTRI Number |
CTRI/2025/05/087118 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
19/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical features of inherited coagulation disorders and study of newer treatment |
|
Scientific Title of Study
|
Clinical profile of inherited coagulation disorders and assessment of efficacy of newer treatment modalities. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aashita Kiran Naik |
| Designation |
Junior Resident Doctor |
| Affiliation |
Goa Medical College and Hospital |
| Address |
Department of General Medicine
Goa Medical College
Bambolim Goa
North Goa
GOA
403202
India |
| Phone |
9404529313 |
| Fax |
|
| Email |
aashitakn20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramnath Nevrekar |
| Designation |
Assistant Professor |
| Affiliation |
Goa Medical College and Hospital |
| Address |
Department of General Medicine
Goa Medical College
Bambolim Goa
North Goa
GOA
403202
India |
| Phone |
9822295825 |
| Fax |
|
| Email |
drramnath.nevrekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aashita Kiran Naik |
| Designation |
Junior Resident Doctor |
| Affiliation |
Goa Medical College and Hospital |
| Address |
Department of General Medicine
Goa Medical College
Bambolim Goa
North Goa
GOA
403202
India |
| Phone |
9404529313 |
| Fax |
|
| Email |
aashitakn20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hemophilia Society Goa, Sabnis Valley, Penha de franc, Aradi socorro Goa 403501 |
|
|
Primary Sponsor
|
| Name |
Hemophilia Society Panaji |
| Address |
Shanti Nagar
Porvorim Goa |
| Type of Sponsor |
Other [non Profit Organisation] |
|
|
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 Aashita Naik |
Goa Medical College |
Wards of Department of General Medicine
Goa Medical College
Bambolim Goa
North Goa
GOA |
9404529313
aashitakn20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOA MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D66||Hereditary factor VIII deficiency, (2) ICD-10 Condition: D67||Hereditary factor IX deficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Emicizumab |
Emicizumab will be given to hemophilia A patients and will be compared to on-demand treatment patients |
| Comparator Agent |
Patients not receiving Emicizumab |
The study with be compared with pateints not receiving emicizumab in pateint suffering from Hemophila A |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Known cases of common inherited coagulation disorders (Hemophilia A, Hemophilia B, Von wilebrand Disease, other factor deficiencies)
Subjects included will be patients with history of spontaneous bleeding in joints, mucocutaneous regions, following trivial trauma
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the decrease in number of bleeding episodes after the intervention |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess efficacy of prophylactic treatment with on-demand in the management of inherited coagulation disorders. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be conducted in a tertiary care centre. Sample size will be 50 Patients will be selected according to the inclusion criteria Patient’s clinical details will be taken retrospectively Patient will be divided into 2 groups of on-demand and prophylactic treatment quality of life will be compared in both groups using Haem-A-QOL questionnaire Statistical All data will be collected and entered in micro-soft excel sheet and will be analysed using SPSS V22 Improvement in quality of life of on-demand treatment with prophylactic treatment will be analysed and p<0.005 will be considered statistically significant
|