CTRI Number |
CTRI/2015/06/005907 [Registered on: 12/06/2015] Trial Registered Prospectively |
Last Modified On: |
26/07/2017 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Biological |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A clinical trial to study the effects of two drugs, R-TPR-007 and Norditropin® Nordilet® in growth hormone deficient children |
Scientific Title of Study
|
Prospective, multi-centric, randomized, open-label, two-arm, parallel group, active control, comparative clinical study to evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of R-TPR-007/ Norditropin® Nordilet® in growth hormone deficient children |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
RLS/TP/2012/02, version 3.0, dated 10th Jul 2014 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sanjeev Hegde |
Designation |
Head Clinical Development |
Affiliation |
Reliance Life Sciences |
Address |
Reliance Life Sciences Pvt.Ltd
Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra 400701, India.
Thane MAHARASHTRA 400701 India |
Phone |
0224067000 |
Fax |
02240678299 |
Email |
sanjeev.hegde@relbio.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sanjeev Hegde |
Designation |
Head Clinical Development |
Affiliation |
Reliance Lifesciences |
Address |
Reliance Life Sciences Pvt.Ltd
Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra 400701, India.
Mumbai MAHARASHTRA 400701 India |
Phone |
0224067000 |
Fax |
02240678299 |
Email |
sanjeev.hegde@relbio.com |
|
Details of Contact Person Public Query
|
Name |
Dr Jay Madkaikar |
Designation |
Project Manager |
Affiliation |
Reliance Lifesciences |
Address |
Reliance Life Sciences Pvt.Ltd
Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra 400701, India.
Thane MAHARASHTRA 400701 India |
Phone |
0224067000 |
Fax |
02240678299 |
Email |
jay.madkaikar@relbio.com |
|
Source of Monetary or Material Support
|
Reliance Life Sciences Pvt. Ltd.
Dhirubhai Ambani Life Sciences Centre
Plot R-282, TTC Area of MIDC
Thane Belapur Road, Rabale, Navi Mumbai 400 701. India
|
|
Primary Sponsor
|
Name |
Reliance Life Sciences Pvt Ltd |
Address |
Dhirubhai Ambani Life Sciences Centre
Plot R-282, TTC Area of MIDC, Thane Belapur Road
Rabale, Navi Mumbai 400 701. India.
|
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 5 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Kumaravel Velayutham |
Apollo Speciality Hospitals |
Apollo Speciality Hospitals, Ground Floor, Department of Pediatric Endocrinology
Lake View Road, K.K.Nagar
Madurai 625020, Tamilnadu, India Madurai TAMIL NADU |
9940582328
drvkumaravel@gmail.com |
Dr Shriraam Mahadevan |
Chennai Meenakshi Multispeciality Hospital |
Meenakshi Multispeciality Hospital, Old 148, New 72, Luz Church Road,Mylopore, Chennai- 600004 Chennai TAMIL NADU |
9840488777 044-24993282 mshriraam@gmail.com |
Dr Jayashri Shembalkar |
Getwell Hospital and Research |
Getwell Hospital & Research Institute, Department of Endocrinology. Ground Floor
20/1, Dr. Khare Marg Dhantoli
Nagpur Nagpur MAHARASHTRA |
7126632200
pkshembalkar@hotmail.com |
DrAnuradha Khadilkar |
Jehangir clinical Development |
Jehangir clinical Development
Centre Pvt Ltd.,Department of Pediatrics, Ground Floor
Jehangir Hospital Premises, 32 Sasoon Road
Pune 411001 Pune MAHARASHTRA |
020-67268800
anuradhavkhadilkar@gmail.com |
Dr B Vivekanand |
King George Hospital |
Dept. Endocrinology,
Superspecialty Block, First Floor, King George Hospital,
Maharanipeta, Visakhapatnam - 530002
India
Visakhapatnam ANDHRA PRADESH |
9440514756
kumarelk@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 5 |
Name of Committee |
Approval Status |
Chennai Meenakshi Hospital Ethics Committee |
Approved |
Ethics Committee Apollo Speciality Hospitals |
Approved |
IEC, Getwel Hospital and Research Institute, Nagpur |
Approved |
Institutional Ethics Committee, King George Hospital |
Approved |
Jehangir Clinical Development |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Growth hormone deficiency in children, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Norditropin® Nordilet® |
Dose: 0.033 mg/kg/day (0.23 mg/kg/week), 7 times a week at night, Route Of Administartion: Subcutaneous, Duration:12 months |
Intervention |
R-TPR-007 |
Dose 0.033mg/Kg/day (0.23mg/kg/week), 7 times a week at night Duration 12 months, Route of administration subcutaneous |
|
Inclusion Criteria
|
Age From |
3.00 Year(s) |
Age To |
11.00 Year(s) |
Gender |
Both |
Details |
Clinically suspected GH-naïve pre-pubertal children
Idiopathic growth hormone deficiency
Patients with ratio of bone age/chronological age of <0.9 with open epiphysis.
Patients who are euthyroid.
Parents willing to give informed consent and subject willing to give assent for the study.
Able to comprehend and willing to come for follow up visits as per protocol
requirement
|
|
ExclusionCriteria |
Details |
Patients with a history of resistance to growth hormone therapy
Patients with any major systemic illness, and/or had known hypersensitivity to study
drug
Patients with active neoplasia or intracranial tumor at screening.
Growth retardation attributable to causes other than GHD
History of Intrauterine growth retardation.
Patients with history of administration of other growth-altering medications.
Patients with abnormal laboratory parameters
Patients who test positive for HIV, HBsAg, or HCV.
History of clinically significant diseases.
Patient participation in another clinical trial 30 days prior to administration of IP.
Any other condition which investigator feels would pose a significant hazard to the
patient, if IP is administered.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Mean change in height at 6 months and 12 months. |
6 months and 12 months from baseline, after start of the therapy |
|
Secondary Outcome
|
Outcome |
TimePoints |
Mean change in % weight increase at 6 months and 12 months
Mean change in BMI at 6 months and 12 months
Mean change in bone age at 12 months
Change in IGF-1 levels.
Pharmacokinetic parameters and pharmacodynamics parameter
Evaluation of safety
Anti rhGH antibody assessments
|
6 months and 12 months from baseline, after start of the therapy |
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
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 3 |
Date of First Enrollment (India)
|
30/07/2015 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
This is a prospective, multi-centric, randomized, open-label, two-arm, parallel group, active control, comparative clinical study to evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of R-TPR-007/ Norditropin® Nordilet® in growth hormone deficient children.
The primary outcome will assess the mean change in height at 6 months and 12 months. |