| CTRI Number |
CTRI/2023/02/049358 [Registered on: 01/02/2023] Trial Registered Prospectively |
| Last Modified On: |
14/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Sovateltide for hypoxic-ischemic encephalopathy in neonates |
|
Scientific Title of Study
|
A multicenter, randomized, double-blind, placebo -controlled, phase-II trial to assess safety, and efficacy of sovateltide in the treatment of hypoxic-ischemic encephalopathy in neonates |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PMZ-1620/CT-2.4/2022,Version 1.0/11January2022 |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Manish S Lavhale |
| Designation |
Managing Director |
| Affiliation |
Pharmazz India Private Limited |
| Address |
Department of Research and Devlopment, H-6,Site-C,Surajpur Industrail Area, Greater Noida, Gautam Buddha Nagar Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201307
India |
| Phone |
9873847397 |
| Fax |
|
| Email |
manish.lavhale@pharmazz.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Gulati |
| Designation |
Chief Operating Officer |
| Affiliation |
Pharmazz India Private Limited |
| Address |
Department of Research and Devlopment, H-6,Site-C,Surajpur Industrail Area, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201307
India |
| Phone |
9811406340 |
| Fax |
|
| Email |
sunil.gulati@pharmazz.com |
|
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Source of Monetary or Material Support
|
| Pharmazz India Private Limited
H-6, Site-C, Surajpur Industrial Area
Greater Noida - 201307 |
|
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Primary Sponsor
|
| Name |
Pharmazz India Private Limited |
| Address |
H-6, Site-C, Surajpur Industrial Area
Greater Noida - 201307
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
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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 |
| DrPavan Hegde |
Father Muller Medical College Hospital |
Department of Paediatrics, Father Muller Medical College Hospital, Father Muller Road, Kankanady, Mangalore, Karnataka-575002, India
Bangalore
KARNATAKA |
9845088116
pavanhegde@hotmail.com |
| Dr Meenakshi Siddappa |
Belagavi Institute of Medical Sciences |
Department of Pediatrics, Dr. B R Ambedkar Road, Sadashiv Nagar, Belagavi-590001, India
Belgaum
KARNATAKA |
9902348209
mnrai16@gmail.com |
| DrMonika Sharma |
Christian Medical College and Hospital |
Department of Pediatrics,Brown Road-141008,India
Ludhiana
PUNJAB |
9814861205
0161-2220002
drsmonika@yahoo.com |
| Dr Chandra Kumar Natarajan |
Kanchi Kamakoti Childs Trust Hospital |
Department of Neonatology
12-A, Nageswara Road, Tirumurthy Nagar
Nungambakkam, Chennai- 600034
Chennai
TAMIL NADU |
9488176225
drchandrakumar@gmail.com |
| Dr Shakal Narayan Singh |
King Georges Medical University |
Department of Pediatrics , King Georges Medical University, Shahmina Road, Lucknow, Uttar Pradesh - 226003, India
Lucknow
UTTAR PRADESH |
9415196707
snsingh@kgmcindia.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee of KKCTH and CTMRF Kanchi Kamakoti CHILDS Trust Hospital 12- A, Nageswara Road Nungambakkam Chennai Chennai Tamil Nadu - 600034 India |
Approved |
| Father Muller Institutional Ethics Committee Father Muller Medical College Father Muller Road, Kankanady, Mangalore, Karnataka-575002, India |
Approved |
| Institutional Ethics Committee Christian Medical College and Hospital, Brown Road,Ludhiana-141008,Punjab,India |
Approved |
| Institutional Ethics Committee BIMS, Belagavi Institute Of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee King Georges Medical University King Georges Medical University Shahmina Road, Chowk, Lucknow, Uttar Pradesh - 226003 India |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P111||Other specified brain damage due to birth injury, (2) ICD-10 Condition: P10-P15||Birth trauma, (3) ICD-10 Condition: P11||Other birth injuries to central nervous system, (4) ICD-10 Condition: P111||Other specified brain damage due to birth injury, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lyophilized Sovateltide Injection 30µg (PMZ-1620) |
Three doses of PMZ-1620 (each dose of 0.3 μg/kg body weight) to be administered as an IV bolus over one minute, at an interval of 3 hours ± 1 hour on day 1. The dose will be repeated on day 3 and day 6 post-randomization |
| Comparator Agent |
Normal Saline |
Normal Saline (Equal volume) + Supportive treatmentIn the saline group, 3 doses of an equal volume of normal saline will be administered as an IV bolus over 1 minute every 3 hours ± 1 hour on days 1, 3, and day 6 post-randomization |
|
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Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
1.Either sex with ≥ 36 weeks of gestational age
2.Receiving supportive management for perinatal asphyxia
3.Perinatal depression, based on at least one of the following:
(a)Apgar score of <5 at 10 minutes
(b)Need for resuscitation (chest compressions or mechanical ventilation) at birth
(c)pH <7.00 or base deficit ≥ 16 mmol/liter in the cord or arterial blood within 60 minutes of birth
(d)Moderate/severe encephalopathy evident by at least 3 of 6 modified Sarnat criteria, present between 1 to 6 hours of birth.
4.Informed consent by one of the parents or a legal representative
|
|
| ExclusionCriteria |
| Details |
1.Gestational age <36 weeks
2.Admitted to hospital12-hoursafter birth
3.A genetic or congenital condition that affects neuronal development
4.TORCH infection
5.Neonatal sepsis
6.Complex congenital heart disease
7.Severe dysmorphic feature
8.Microcephaly (head circumference < 2 SDs below mean for gestational age)
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of patients with death or disability (moderate/severe) |
Day-1 to 24 Months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Bayley Scales of Infant and Toddler DevelopmentScores |
24 months |
| Cognitive, Language, Motor, Social-Emotional, and General Adaptive Scales Score as assessed by Bayley Scales of Infant and Toddler Development (BSID)TM measured |
at 6 months after initiation of treatment and then at every 6 months interval |
| Change in the proportion of children with disabling cerebral palsy |
24 months |
| Change in the proportion of patients with seizures Clinical or electrical seizuresat birth, at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 7 days, 30 days, 6 months after initiation of treatment, and then at every 6 months interval |
24 months |
| The number of patients with brain injury (MRI or EEG evidence of brain injury). |
14 days |
| Change in the proportion of patients with blindness or hearing impairment |
24 months |
| Incidence of sovateltide related adverse events |
24 months |
| The number of patients not receiving complete treatment due to intolerance to sovateltide |
7 days |
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
20/02/2023 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
Modification(s)
|
This is a multicenter, randomized, double-blind, placebo-controlled, phase-II study to assess the safety and efficacy of sovateltide for the treatment of perinatal asphyxia caused hypoxic-ischemic encephalopathy (HIE) in neonates. This protocol is designed to develop a novel first-in-class treatment for hypoxic-ischemic encephalopathyin neonates. For an individual patient, the duration of the study will be 24 months. At visit 1, a total of 40 patients with perinatal asphyxia/perinatal depression will be randomized 1:1 into 2 treatment groups after meeting the eligibility criteria. An Interactive Web Response System (IWRS) will be used to randomize the eligible patient to the treatment groups. Group 1: Sovateltide + Supportive treatment for perinatal asphyxia Group 2: Normal Saline (Equal volume) + Supportive treatment for perinatal asphyxia Sovateltide or saline will be administered as an IV bolus dose over 1 minute. In the sovateltide group, 3 doses of sovateltide, at 0.3 μg/kg body weight will be administered as an (IV) bolus over 1 minute every 3 hours ± 1 hour on day 1, 3, and day 6 (total dose/day: 0.9 µg/kg body weight). In the saline group, 3 doses of an equal volume of normal saline will be administered as an IV bolus over 1 minute every 3 hours ± 1 hour on days 1, 3, and day 6 post-randomization. In both treatment groups, patients will be provided supportive treatment for perinatal asphyxia. Every effort will be made to have drug administration at the same time on days 1, 3 and, 6. Each patient will be monitored closely throughout his/her hospitalization and will be followed for 24 months from randomization. Each subject will be assessed for efficacy and safety parameters over 24 months from randomization. |