| CTRI Number |
CTRI/2021/08/035630 [Registered on: 13/08/2021] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing Experiences With Hemophilia A and B: Patient and Caregiver Interviews |
|
Scientific Title of Study
|
Assessing Experiences with Haemophilia A and B: Patient and Caregiver Interviews |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Savita Rangarajan |
| Designation |
Consultant Haematologist |
| Affiliation |
K J Somaiya Hospital and Research Center |
| Address |
Clinical Trial and Research Unit (Sathgen Lab), College Building, 2nd floor, K J Somaiya Hospital and Research Center, Somaiya Ayurvihar
Complex Eastern Express Hwy, Sion East
Mumbai
MAHARASHTRA
400022
India |
| Phone |
|
| Fax |
|
| Email |
rangarajansavita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita Rangarajan |
| Designation |
Consultant Haematologist |
| Affiliation |
K J Somaiya Hospital and Research Center |
| Address |
Clinical Trial and Research Unit (Sathgen Lab), College Building, 2nd floor, K J Somaiya Hospital and Research Center, Somaiya Ayurvihar
Complex Eastern Express Hwy, Sion East
Mumbai
MAHARASHTRA
400022
India |
| Phone |
|
| Fax |
|
| Email |
rangarajansavita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savita Rangarajan |
| Designation |
Consultant Haematologist |
| Affiliation |
K J Somaiya Hospital and Research Center |
| Address |
Clinical Trial and Research Unit (Sathgen Lab), College Building, 2nd floor, K J Somaiya Hospital and Research Center, Somaiya Ayurvihar
Complex Eastern Express Hwy, Sion East
Mumbai
MAHARASHTRA
400022
India |
| Phone |
|
| Fax |
|
| Email |
rangarajansavita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanofi Aventis Groupe, 54 rue La Boetie 75008 Paris France |
|
|
Primary Sponsor
|
| Name |
Sanofi Aventis Groupe |
| Address |
54 rue La Boetie 75008 Paris France |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Kantar |
3rd Floor, Bay99 – A WPP Campus,
The ORB, JW Marriott Sahar, Andheri (E),
Mumbai- 400099 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alok Srivastava |
Christian Medical College - CMC Vellore |
Department of Haematology
Head, Centre for Stem Cell Research
Christian Medical College
Vellore
TAMIL NADU |
9894903340
aloks@cmcvellore.ac.in |
| Dr Savita Rangarajan |
K.J Somaiya Hospital |
CTRU (Sathgen lab) College building, 2nd floor, K J Somaiya Hospital and Research Center, Eastern Express Highway, Sion East, Mumbai-400022
Mumbai
MAHARASHTRA |
9619525341
rangarajansavita@gmail.com |
| Dr Ross Cecil Reuben |
St. Johns Medical College and Hospital |
Room Number 52, Ground Floor, Department of Medicine,
St. Johns Medical College and Hospital, Sarjapur Road,
Bangalore - 560034
Bangalore
KARNATAKA |
08049466346
cecilrross@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Christian Medical College - CMC Vellore |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| K.J Somaiya Hospital and Research Centre |
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
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Patients who had participated in phase 3 would be selected from 3 sites. By recruiting patients from multiple sites in India, it is anticipated that the interview substudy sample will be somewhat representative of the overall clinical trial population in India. No patient (or caregiver) clinical or demographic characteristics will be targeted during sample selection.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the experiences of patients who have participated in phase 3 clinical trial |
after 1 year of 1st recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know the experiences of patients who have participated in phase 3 clinical trial |
after 1 year of 1st recruitment |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "14"
Final Enrollment numbers achieved (India)="14" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
16/08/2021 |
| 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="0"
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)?
Response - NO
|
|
Brief Summary
|
Sanofi is evaluating fitusiran for the treatment of patients with hemophilia A or B, with and without inhibitors Fitusiran is currently being evaluated in several phase 3 clinical trials (ATLAS-INH and ATLAS-A/B) and one open-label extension study (ATLAS-OLE) In collaboration with Sanofi, RTI-HS has designed a stand-alone study in which telephone interviews will be conducted with up to 20 English-speaking participants (adult patients or parents/legal guardians of minors) from clinical sites in India that are participating in one or more of the ATLAS studies Objective •Obtain a better understanding of patients’ or caregivers’: –Perception of treatment benefit (e.g., hemostatic protection, ambulation, joint functioning) –Preferences for and satisfaction with hemophilia treatments, including fitusiran –Experiences with hemophilia and its treatments prior to the ATLAS studies •Data from the interviews will be used to: –Obtain a better understanding of hemophilia and fitusiran –Support publications |