| CTRI Number |
CTRI/2024/07/069770 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study about how well emicizumab prevents bleeding in haemophilia A patients and its overall impact on their health outcomes
|
|
Scientific Title of Study
|
To Study Efficacy and Outcome of Emicizumab Prophylaxis in Patients of Hemophilia A
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Himani Dendor |
| Designation |
Postgraduate Resident |
| Affiliation |
Rnt medical College udaipur |
| Address |
Department of Paediatrics Rnt medical College udaipur near court choraha
Udaipur
RAJASTHAN
313001
India |
| Phone |
9521824705 |
| Fax |
|
| Email |
himanidendor8499@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R L Suman |
| Designation |
Senior professor |
| Affiliation |
Rnt medical collage udaipur |
| Address |
Department of Paediatrics Rnt medical College udaipur near court choraha
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414155775 |
| Fax |
|
| Email |
sumanrl@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr R L Suman |
| Designation |
Senior professor |
| Affiliation |
Rnt medical collage udaipur |
| Address |
Department of Paediatrics Rnt medical College udaipur near court choraha
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414155775 |
| Fax |
|
| Email |
sumanrl@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| MBGH HOSPITAL UDAIPUR Rajasthan India pincode 313001 |
|
|
Primary Sponsor
|
| Name |
Rnt medical College |
| Address |
MBGH HOSPITAL udaipur Rajasthan India
Pincode 313001 |
| 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 Himani |
Rnt medical College udaipur |
Room number 509 hemophilia ward Department of Paediatrics Rnt medical College udaipur near court choraha
Udaipur
RAJASTHAN |
9521824705
himanidendor8499@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| R.N.T. medical College and controller and attached hospitals udaipur 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Emicizumab |
Initial 1 month - 3mg/ kg weekly
Then 6mg /kg per month |
| Comparator Agent |
Factor viii
Recombinant factor |
Continue same treatment
40- 50 IU/ kg |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
New Confirmed case of hemophilia A
Patients with a documented baseline bleeding frequency, allowing for a comparison of bleeding episodes before and after emicizumab treatment
Patients who give informed consent
|
|
| ExclusionCriteria |
| Details |
Presence of coagulation disorders other than hemophilia A, which may confound the study results
Significant comorbidities or medical conditions that may independently affect the outcomes of interest. Like liver diseases
Patients without proper informed consent
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reducing bleeding events in haemophilia A patient
And evaluating efficacy of emicizumab
|
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reducing auto antibodies formation |
1 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
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
|
This study aims to assess Emicizumab’s efficacy and outcomes in managing Hemophilia A patient evaluating its safety and bleeding episode reduction. it’s a randomized controlled trial involving 66 patients. Patients will be categorized into group A)study group receiving Emicizumab and ,group B) control group receive other treatment like factor viii . assessment include annual bleeding events, laboratory analyses, and adverse event monitoring. Ultimately, the research aims to provide valuable insights into Emicizumab’s efficacy in managing Hemophilia A, potentially offering a safer and more effective treatment option for patients.
|