| CTRI Number |
CTRI/2024/12/078228 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Biological |
| Study Design |
Other |
|
Public Title of Study
|
A study to learn about Somatrogon in patients with pediatric growth hormone deficiency (p GHD) in India |
|
Scientific Title of Study
|
A multicenter, non-interventional prospective active surveillance study among patients receiving Somatrogon under routine clinical care in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol C0311026 (Version 2.0 dated 29 May 2024) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukundraj Keny |
| Designation |
Medical Advisor-Rare Disease |
| Affiliation |
Pfizer Products India Private Limited |
| Address |
Pfizer Products India Private Limited, 1802/1902, The Capital, ‘G’ Block, BKC, Bandra (East),
Mumbai
MAHARASHTRA
400051
India |
| Phone |
9011168903 |
| Fax |
|
| Email |
mukundrajsatyaranjan.keny@pfizer.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukundraj Keny |
| Designation |
Medical Advisor-Rare Disease |
| Affiliation |
Pfizer Products India Private Limited |
| Address |
Pfizer Products India Private Limited, 1802/1902, The Capital, ‘G’ Block, BKC, Bandra (East),
Mumbai
MAHARASHTRA
400051
India |
| Phone |
9011168903 |
| Fax |
|
| Email |
mukundrajsatyaranjan.keny@pfizer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukundraj Keny |
| Designation |
Medical Advisor-Rare Disease |
| Affiliation |
Pfizer Products India Private Limited |
| Address |
Pfizer Products India Private Limited, 1802/1902, The Capital, ‘G’ Block, BKC, Bandra (East),
Mumbai
MAHARASHTRA
400051
India |
| Phone |
9011168903 |
| Fax |
|
| Email |
mukundrajsatyaranjan.keny@pfizer.com |
|
|
Source of Monetary or Material Support
|
| Pfizer Products India Private Limited, 1802/1902, The Capital, ‘G’ Block, BKC, Bandra (East), Mumbai – 400051, India |
|
|
Primary Sponsor
|
| Name |
Pfizer Products India Private Limited |
| Address |
1802/1902, The Capital, ‘G’ Block, BKC, Bandra (East), Mumbai – 400051, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Soundaram Valliyappan |
Apollo Childrens Hospital |
Department of Endocrinology, 1st Floor, Room No.104, Out-patient Block, Apollo childrens hospital, No. 15. Shafi Mohammed Road, Thousand Lights, Chennai-600006
Chennai
TAMIL NADU |
9566148723
soundaramvalliyappan@gmail.com |
| Dr Prashant Patil |
Apollo Hospitals, Mumbai |
First Floor, Department of Pediatrics, Plot # 13, Off Uran Road, Parsik Hill Rd, Sector 23, CBD Belapur, Navi Mumbai- 400614
Mumbai
MAHARASHTRA |
9869109959
dr_prash4u@yahoo.com |
| Dr Kumaravel Velayutham |
Apollo Specialty Hospitals, Madurai |
Ground Floor, Department of Pediatric Endocrinology, Lake
View Road, K.K. Nagar, Madurai- 625020, Tamil Nadu
Madurai
TAMIL NADU |
9940582328
drvkumaravel@gmail.com |
| Dr Ahila Ayyavoo |
G Kuppuswamy Naidu Memorial Hospital |
Department of Paediatrics, 4th floor, GKNM Medical Research Institute and Out Patient Centre, G Kuppuswamy Naidu Memorial Hospital, Pappanaicken Palayam, Coimbatore, Tamil Nadu 641037
Coimbatore
TAMIL NADU |
9442645072
ahilaashwath@gmail.com |
| Dr I P S Kochar |
Indraprastha Apollo Hospital |
Second floor, Department of Pediatrics, Sarita Vihar, Delhi-Mathura Road - 110076
New Delhi
DELHI |
9910240919
ipskochar2924@gmail.com |
| Dr Anurag Bajpai |
Regency Hospital Ltd |
Department of Endocrine – Paediatric Endocrinology, 2nd Floor, Room No: S9, Regency Hospital, Sarvodaya Nagar, Kanpur, UP - 208005
Kanpur Nagar
UTTAR PRADESH |
9454081769
dranurag.bajpai@gmail.com |
| Dr Shaila Shamanur |
Shivajyoti Clinic |
3366, 13th Main, Sai Darshan Road, Indiranagar, Bengaluru-560008, Karnataka, India
Bangalore
KARNATAKA |
9900655552
shailashamanur@gmail.com |
| Dr Archana Arya |
Sir Ganga Ram Hospital |
Room No. F-85, Department of Pediatrics, Sir Ganga Ram Hospital Marg, Rajinder
Nagar, New Delhi - 110060
New Delhi
DELHI |
9999008525
adayal35@hotmail.com |
| Dr Dhivyalakshmi Jeevarathnam |
Sri Ramachandra Medical College & Research Institute |
Department of Paediatrics - Division of Paediatric Endocrinology, Sri Ramchandra Medical Centre, Block A1, 1st Floor, No.1 Ramchandra Nagar, Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU |
9566781313
laksdhivya@gmail.com |
| Dr Abhishek Kulkarni |
T2T Hormone Clinics India Private Limited |
118/Morya Estate, 1st floor, opposite Infiniti mall, New link road, Andheri West – 400053,Mumbai, Maharashtra, India
Mumbai
MAHARASHTRA |
9819647783
kulkarniabhishekj@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
| Ethics Committee of Sir Ganga Ram Hospital |
Approved |
| Institutional Ethics Committee GKNM Hospital |
Approved |
| Institutional Ethics Committee SRIHER |
Approved |
| Institutional Ethics Committee- Clinical Studies Apollo Hospital Enterprise Limited |
Approved |
| Institutional Ethics Committee- Clinical Studies Apollo Hospital Enterprise Limited |
Approved |
| Institutional Ethics Committee- Clinical Studies Apollo Speciality Hospitals |
Approved |
| Institutional Ethics Committee- Clinical Studies Indraprastha Apollo Hospitals |
Approved |
| Regency Hospital Ethics Committee |
Approved |
| Vision Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E230||Hypopituitarism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Somatrogon |
Somatrogon 24 mg/1.2 mL and 60 mg/1.2 ml solution for injection in pre-filled pen (Genryzon) administered once weekly by subcutaneous injection for a duration of 36 months |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Prescription of Somatrogon for p GHD in participants aged 3 years or more.
2. Evidence of a personally signed and dated informed consent document indicating that the participant (or a legally acceptable representative) has been informed and agree to all pertinent aspects of the study. Assent will also be sought from children of applicable age in line with national guidance. In all cases, the treating physician responsible for enrolling the participant into the study will assess the appropriateness of gaining assent from a participant (or a legally acceptable representative) at their discretion during routine clinical care. |
|
| ExclusionCriteria |
| Details |
1. Participation in any interventional clinical trials at the time of enrollment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate incidence rates (IRs) of safety events of interest among participants on Somatrogon. |
Data will be collected at baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate treatment adherence
and compliance of Somatrogon |
Data will be collected at baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/12/2024 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 is a multi-centre, non-interventional, prospective active surveillance study of participants exposed to Somatrogon, as prescribed by the treating physician in routine realworld clinical practices in India. Participant treatment with a particular therapeutic regimen will be determined at the discretion of the treating physician under routine clinical care. This study involves primary data collection with investigators and sites. Primary Objectives: To estimate IRs of safety events of interest among participants on Somatrogon. Secondary Objectives: To evaluate treatment adherence and compliance of Somatrogon. |