| CTRI Number |
CTRI/2022/09/045538 [Registered on: 15/09/2022] Trial Registered Prospectively |
| Last Modified On: |
07/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluate the Efficacy and Safety of Thymosin α-1 (Tα1) with comparision of placebo in sepsis patient by using with Standrad of care |
|
Scientific Title of Study
|
A Double Blind, Randomized, Placebo Controlled, Multi-Center, Two-Arm, Phase III Clinical Study to Evaluate the Efficacy and Safety of Thymosin α-1 (Tα1) as an add-on Treatment to Existing Standard of Care Treatment in Sepsis Patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GB_THY_0002_22 Ver.no. 02 date 09.05.2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Adarsh Shetty |
| Designation |
Senior Manager - Medical Affairs |
| Affiliation |
Gufic Biosciences Limited |
| Address |
Subhash Road-A Block Vile Parle East
Mumbai
MAHARASHTRA
400057
India |
| Phone |
9844968062 |
| Fax |
|
| Email |
dr.adarsh.shetty@guficbio.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Adarsh Shetty |
| Designation |
Senior Manager - Medical Affairs |
| Affiliation |
Gufic Biosciences Limited |
| Address |
Subhash Road-A Block Vile Parle East
Mumbai
MAHARASHTRA
400057
India |
| Phone |
9844968062 |
| Fax |
|
| Email |
dr.adarsh.shetty@guficbio.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Vairamuthu Ammaiyappan |
| Designation |
Associate Director |
| Affiliation |
iDD Research Solutions Pvt Ltd |
| Address |
Tek Meadows Campus No 51 3rd C block, Old Mahabalipuram Rd Sholinganallur
Chennai
TAMIL NADU
600119
India |
| Phone |
9606829331 |
| Fax |
|
| Email |
vairamuthu.ammaiyappan@iddresearch.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Gufic Biosciences Limited |
| Address |
Subhash Road A Block Vile Parle East Mumbai Maharashtra India 400057 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Shashank Srivastava |
Aarvy Hospital |
Critical care department, 530/18, Jail Rd, Civil Lines, Gurugram, Haryana 122001
Gurgaon
HARYANA |
9911008948
dr.shashanksrivastava@gmail.com |
| Dr Vijay Gaikwad |
Govt. Medical College (GMC) |
Department of medicine, JIlah Peth, GMC
Jalgaon
MAHARASHTRA |
9422274644
drvijaygka@gmail.com |
| Dr Yandrapati Gnana Sundara Raju |
King George Hospital Andhra Medical College |
HOD Room first floor, department of Medicine, Rajendra Prasad ward King George Hospital and Andhra Medical College Maharanipetha Visakhapatnam 530002
Visakhapatnam
ANDHRA PRADESH |
9573606609
drysundarrajuresearch@gmail.com |
| Dr Chandrasekhar Valupadas |
Mahtma Gandhi Memorial Hospital |
Department of General Medicine first floor, Sherpura 506002
Warangal
TELANGANA |
9346950050
drchandrasekhar.krcwgl@gmail.com |
| Dr Ganshyam Jagathkar |
Medicover Hospitals |
Department of Critical care Behind Cyber Tower Hitech City Madhapur
Hyderabad
TELANGANA |
9949001344
drganshyamj.hitech@medicoverhospitals.in |
| Dr Anshul Jain |
MLB medical college |
Critical care of medicine & department of anathesia, Kanpur Road, Jhansi
Jhansi
UTTAR PRADESH |
9411685406
dranshulrachna@rediffmail.com |
| Dr Ashish Omprakash Goyal |
Orchid Speciality Hospital |
first Floor room No.103, L Square Porwal Road sr No 282/3/3 off Dhanori Jakat Naka Lohgoan
Pune
MAHARASHTRA |
75072472447
orchidhospital.research@gmail.com |
| Dr Anirudh Kumar |
Ozone Hospital |
25, road number 1, Narsimhapuri colony, HUDA colony, kothapet, Hyderabad-500035, Telangana
Hyderabad
TELANGANA |
7981364744
anis0408@gmail.com |
| Dr Dhruva Chaudhry |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
PCCM department,Rohtak, Haryana-124001
Rohtak
HARYANA |
9416051616
dhruvachaudhry@yahoo.co.in |
| Dr Amrita Gupta |
SN Medical College |
6th floor, Department of anaesthesia New Surgica Bulidin Near Central Library, Moti Katra Mantola Agra U.P-282003
Agra
UTTAR PRADESH |
09837077784
amritagupta78@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Excel Hospital Institutional ethics committee |
Approved |
| GeneBandhu Independent Ethics Committee |
Approved |
| Institutional Ethics committee Government Medical College Jalgoan |
Approved |
| Institutional Ethics committee King George Hospital |
Approved |
| Institutional Ethics committee Maharani laxmi bai medical college and Associated Hospital |
Approved |
| Institutional Ethics committee Medicover Hospital |
Approved |
| Institutional Ethics committee pt BD Sharma PGIMS |
Approved |
| Institutional Ethics committee SN Medical College |
Approved |
| Kakatiya Ethics Committee |
Approved |
| Orchid Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B96||Other bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
patients will be administered 2 subcutaneous injectionsof Placebo with SOC from Day 1 to Day 7/ as per investigator’s discretion. |
| Intervention |
Thymosin Alpha 1 |
patients will be administered 2 subcutaneous injections of 1.6 mg Tα1 with SOC.from Day 1 to Day 7/ as per investigator’s discretion.
Each vial contains : Thymosin Alpha 1…..1.6mg
Excipients...... q.s (Lyophilized)
Sterile water for Injections IP 1ml Ampoule
Manufactured by Gufic Biosciences Ltd.India
With SOC |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Male/female of ≥ 18 years of age at the time of consent
2. Patient / Legally Acceptable Representative who can and willing to provide Informed Consent
3. Patient diagnosed with sepsis according to the sepsis diagnosis criteria of "Surviving Sepsis Campaign: International Guidelines for Management of Sepsis 3 and Septic Shock: 2016"
4. Patient with total SOFA scores ≥2 (Reports within last 24 hours to be considered for screening. In case of multiple reports, latest one should be considered.)
5. Patient with confirmed or suspected infection and satisfy at least one of the following: a. Pathogenic microbes grow in blood and at aseptic locations b. Presence of abscess or partially infected tissues c. Suspected infection identified by at least one of the following evidence Leukocytes at normal aseptic locations - Organic perforation (confirmed by imaging evidence, examination result or intestinal content leak during drainage) - Imaging evidence of pneumonia accompanied by purulent secretion
- Related syndromes with high infection risk (cholangitis for example)
6. Patient/ patient’s LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements |
|
| ExclusionCriteria |
| Details |
1.Patient Ë‚ 18 years of age
2. Patient in need for immediate surgery
3. Patient with history of organ or bone marrow transplantation
4. Patient not expected to survive 28 days given their preexisting uncorrectable medical condition
5. Female patient who is breast-feeding or pregnant
6. Patient who has participated in another trial with an investigational drug within 1 month prior to this trial.
7. Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Sequential Organ Failure Assessment (SOFA) score |
from Screening/ Baseline (Day 1) and End of treatment ( Day 7) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of emerging infection within 7 days |
from Screening/ Baseline (Day 1) and End of treatment ( Day 7) |
| Clearance rate of pathogenic microorganism over a period of 7-days |
from Screening/ Baseline (Day 1) and End of treatment ( Day 7) |
| Duration of hospitalization |
Day 28 |
| Ventilator-free days |
time frame 28 days |
| ICU-free days |
time frame28 days |
| Continuous Renal Replacement Therapy (CRRT) free days |
Time frame 28 days |
| Vasoactive agents-free days |
Time frame 28 days |
| Change in Absolute Lymphocyte count from Screening/ Baseline (Day 1) and End of Treatment |
Screening/ Baseline (Day 1) and End of treatment ( Day 7) |
| Change in CD4/CD8 ratio |
Screening/ Baseline (Day 1) and End of treatment ( Day 7) |
| Change in Neutrophil-lymphocyte (NLR) ratio |
Screening/ Baseline (Day 1) and End of treatment ( Day 7) |
| Change in Tumour Necrosis Factor (TNF) levels |
Screening/ Baseline (Day 1) and End of treatment ( Day 7) |
| Change in C-Reactive Protein (CRP) levels |
Screening/ Baseline (Day 1) and End of treatment ( Day 7) |
| Change in serum lactate levels only in suspected patients with septic shock. |
Screening/ Baseline (Day 1) and End of Treatment (Day 7) |
| Number of days without antibiotics |
Time Frame: 28 days |
| Incidences of all-cause hospital mortality |
From date of Drug administered until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 28 days] |
| Number of Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event |
Time frame 28 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
19/09/2022 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
- |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sepsis is a significant heterogeneous clinical syndrome with the characters of high mortality and incidence. It is a life-threatening organ dysfunction caused by host immune response to infection. IP is Thymosin alpha 1 (Tα1), acting as an immune modulator, exerts great biological influence in activating and restoring the dysregulated immune response for patients with sepsis Total 120 eligible patients will be enrolled in 1:1 ratio in two treatment arms (60 patients in each arm).7 days of treatment and follow up on Day 28. |