| CTRI Number |
CTRI/2015/02/005556 [Registered on: 19/02/2015] Trial Registered Prospectively |
| Last Modified On: |
28/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A phase III clinical trial study to evaluate the efficacy and safety of Tenecteplase (TNK-TPA) in Acute Ischemic Stroke patients |
|
Scientific Title of Study
|
Clinical trial to assess the efficacy and safety of TNK-TPA in Acute Ischemic Stroke |
| Trial Acronym |
TNK-TPA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GBL/TNK-TPA/AIS/2012/001 Version 01 Date 10.05.2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajeshkumar Singh |
| Designation |
AGM |
| Affiliation |
Gennova Biopharmaceuticals Limited |
| Address |
Plot No. P1, IT-BT Park, Phase-II, MIDC, Hinjewadi, Pune - 411 057
Pune
MAHARASHTRA
411057
India |
| Phone |
02039821502 |
| Fax |
|
| Email |
Rajeshkumar.Singh@gennova.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeshkumar Singh |
| Designation |
AGM |
| Affiliation |
Gennova Biopharmaceuticals Limited |
| Address |
Plot No. P1, IT-BT Park, Phase-II, MIDC, Hinjewadi, Pune - 411 057
Pune
MAHARASHTRA
411057
India |
| Phone |
02039821502 |
| Fax |
|
| Email |
Rajeshkumar.Singh@gennova.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeshkumar Singh |
| Designation |
AGM |
| Affiliation |
Gennova Biopharmaceuticals Limited |
| Address |
Plot No. P1, IT-BT Park, Phase-II, MIDC, Hinjewadi, Pune - 411 057
Pune
MAHARASHTRA
411057
India |
| Phone |
02039821502 |
| Fax |
|
| Email |
Rajeshkumar.Singh@gennova.co.in |
|
|
Source of Monetary or Material Support
|
| Gennova Biopharmaceuticals Ltd, Plot No. P1, I.T.-B.T. Park, Phase-II, MIDC, Hinjwadi, Pune – 411 057. India. |
|
|
Primary Sponsor
|
| Name |
Gennova Biopharmaceuticals Ltd |
| Address |
Plot No. P1, IT-BT Park, Phase-II, MIDC, Hinjwadi, Pune 411057 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 19 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meenakshi Sundaram Salvadeeswaran |
Apollo Speciality Hospitals |
Lake view road, K K Nagar, Madurai-625020
Madurai
TAMIL NADU |
9842980211
04522581154
drsundarsms@gmail.com |
| Dr S Kumaravelu |
Dr. Ramesh Cardiac & Multispeciality Hospital Ltd. |
Department of Neurology, Dr. Ramesh Cardiac & Multispeciality Hospital Ltd., Ring Road, Near ITI College, Vijayawada – 520008
Guntur
ANDHRA PRADESH |
9553651777
neurovelu@yahoo.co.in |
| Dr S Kumaravelu |
Dr. Ramesh Cardiac and Multispeciality Hospital Pvt Ltd. |
Beside Hindu College Grounds, Guntur - 04
Guntur
ANDHRA PRADESH |
9553651777
neurovelu@yahoo.co.in |
| Dr Sushma Sharma |
Fortis Escorts Hospital |
Neelam Bata Road, Faridabad - 121001
Faridabad
HARYANA |
8377994629
01292416260
sushma.sharma@fortishealthcare.com |
| Dr Vineet Sehgal |
Fortis Escorts Hospitals |
Department of Neurology, OPD Room No. 8, Fortis Escorts Hospitals [A unit of Fortis Hospitals Limited], Majitha Verka Bypass, Amritsar – 143004, Punjab
Amritsar
PUNJAB |
01833012222
vineetsehgal2122@yahoo.co.in |
| Dr Sanjay Kumar Saxena |
Fortis Hospital |
Department of Neurology, Fortis Hospital, Noida, B-22, Sector 62, Noida-201301
Gautam Buddha Nagar
UTTAR PRADESH |
9810148197
sansax2009@yahoo.com |
| Dr Praveen Gupta |
Fortis Memorial Research Institute |
Sector 44, opp Huda City Metro Station, Gurgaon - 122002
Gurgaon
HARYANA |
9891907913
praveen.gupta4@fortishealthcare.com |
| Dr Sunil K Narayan |
Jawaharlal Institute of Postgraduate Medical Education And Research [JIPMER] |
Jawaharlal Institute of Postgraduate Medical Education And Research [JIPMER], Department of Neurology, JIPMER, Dhanvanti Nagar, Puducherry – 605006
Pondicherry
PONDICHERRY |
04132297280
sknarayan@gmail.com |
| Dr M Pradeep |
K G Hospital |
KG Hospital and post graduate institute, No.5, Arts College Road, Coimbatore - 641018
Coimbatore
TAMIL NADU |
9447092567
04222211212
drmpradeep@rediffmail.com |
| Dr Pamidimukkala Vijaya |
Lalitha Super Specialities Hospital Pvt. Ltd |
Department of Neurology, Dr P Vijay Neurology-OPD, Lalitha Super Specialities Hospital Pvt. Ltd., Kothapet, Guntur – 522001
Guntur
ANDHRA PRADESH |
08632222866
drvijaya.lssh@gmail.com |
| Dr Rangasetty Srinivasa |
M S Ramaiah Medical College & Hospital |
Department of Neurology, New BEL Road, Bangalore - 560054
Bangalore
KARNATAKA |
9448040589
08023601983
drrsrinivasa@hotmail.com |
| Dr Puneet Agarwal |
Max Super Speciality Hospital |
1, Press Enclave Road, Saket, New Delhi - 110017
South
DELHI |
9971545666
01126514040
puneet.agarwal@maxhealthcare.com |
| Dr Arun Garg |
Medanta Institute of Neurosciences |
Medanta Institute of Neurosciences, Division of Neurosciences 6th Floor, Medanta – The Medicity, Sec 38, Gurgaon, Haryana 122001
Gurgaon
HARYANA |
01244141414
arun.garg@medanta.org |
| Dr Shripad Pujari |
Noble Hospital Pvt Ltd |
153, Magarpattacity Road, Hadapsar, Pune - 411013
Pune
MAHARASHTRA |
9881009233
02026890157
drshripadpujari@gmail.com |
| Dr U K Misra |
SGPGIMS |
SGPGIMS, Raebareli Road, Lucknow - 226014
Lucknow
UTTAR PRADESH |
9450653685
05222668811
drukmisra@rediffmail.com |
| Dr Arvind Sharma |
Shalby Hospitals |
Department of Neurology, Shalby Hospitals, Opp. Karnavati Club, S.G. Highway, Ahmedabad – 380015, Gujarat
Ahmadabad
GUJARAT |
07940203148
arvind.sharma@shalby.org |
| Dr Thomas Mathew |
St. John’s Medical College Hospital |
Department of Neurology, St. John’s Medical College Hospital, Sarjapur Road, Bangalore – 560034
Bangalore
KARNATAKA |
08022065635
chakkuthom@hotmail.com |
| Dr Vikram Sharma |
St. Theresa’s General Hospital |
Department of Neurology, Room No. 25, St. Theresa’s General Hospital, Santhnagar, Hyderabad – 500018
Hyderabad
ANDHRA PRADESH |
04023814556
drvikramsharma@gmail.com |
| Dr Pandurang Ramesh Wattamwar |
United CIIGMA Hospital |
Department of Neurology, United CIIGMA Hospital, Survey No. 10, Shahanoor wadi, Dargha Road, Aurangabad – 431005. Maharashtra
Aurangabad
MAHARASHTRA |
7387013361
drpandu1976@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 19 |
| Name of Committee |
Approval Status |
| Ethics Committee Apollo Speciality Hospital |
Approved |
| Ethics Committee Fortis Escort Hospital and Research Centre |
Approved |
| Ethics Committee Kodlikeri Memorial Hospital & CIIGMA Hospital |
Approved |
| Ethics Committee, St. Theresas General Hospital |
Approved |
| Fortis Hospital Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Fortis Escorts Hospitals |
Approved |
| Institutional Ethics Committee JIPMER |
Approved |
| Institutional Ethics Committee Shalby Hospitals |
Approved |
| Institutional Ethics Committee, Dr Ramesh Hospitals |
Approved |
| Institutional Ethics Committee, Fortis Memorial Research Institute |
Submittted/Under Review |
| Institutional Ethics Committee, Max Healthcare Super Speciality Hospital |
Approved |
| Institutional Ethics Committee, MS Ramaiah Hospital |
Approved |
| Institutional Ethics Committee, Noble Hospital |
Approved |
| Institutional Ethics Committee, SGPGI Bioethical Cell |
Approved |
| Lalitha Super Specialities Hospital Ethics Committee |
Approved |
| Medanta Institutional Ethics Committee |
Approved |
| Regional Ethics Committee, KG Hospital |
Approved |
| St Johns Medical College & Hospital Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Tenecteplase (TNK-TPA) |
Each vial contains:
Recombinant Tissue Plasminogen Activator (TNK-t-PA)20 mg
As lyophilized powder to be reconstituted with 10 ml of sterile water for injection.
Study Treatment: 0.2 mg/kg of TNK-TPA as i.v. bolus |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Acute ischemic stroke with serious measurable deficit on National Institute of Health Stroke Scale (NIHSS)
2.Treatment within 3 hours of stroke onset
3.Age 18 to 75 years
4.Patient or legally acceptable representative willing to give informed written consent before study procedure
|
|
| ExclusionCriteria |
| Details |
1.Minor stroke symptoms, or major symptoms rapidly improving
2.Intracranial hemorrhage on pretreatment head computerised tomography (CT) scan
3.Clinical presentation suggesting subarachnoid haemorrhage
4.Pregnancy
5.Known bleeding diathesis and/or platelet count < 100000 mm3
6.Patient taking oral anticoagulants
7.Patients who have received heparin within 48 hours
8.Major surgery or serious trauma within 14 days; serious head trauma within 3 months
9.Gastrointestinal or urinary tract hemorrhage within 21 days
10.Arterial puncture at a noncompressible site or lumbar puncture within 7 days
11.Uncontrolled baseline hypertension ( >185/110 mm Hg)
12.Clinical stroke within 3 months or history of intracranial hemorrhage
13.Myocardial infraction in past 30 days
14.Other serious medical illness likely to interfere with treatment or treatment might adversely affect that illness
15.Seizure at stroke onset
16.Confounding pre-existent neurological or psychiatric disease
17.Any other investigational drug within 14 days
18.Large areas (greater than one lobe) of obvious low density on baseline head CT scan
19.Unlikely to complete the protocol follow-up
20.Any condition that, in the opinion of the investigator, does not justify the patients’ inclusion in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neurological improvement at 24 hours as indicated by neurological improvement defined prospectively as an improvement of more than or equal to 8 points or a score of 0 on the NIH Stroke scale will be taken as primary efficacy variable |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Neurological improvement measured by NIH Stroke Scale at 7 days, 1 month and at 3 months
Barthel index, modified Rankin scale and Glasgow Outcome scale performed at 7 days, 1 month and 3 months |
7 days, 1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/02/2015 |
| Date of Study Completion (India) |
28/10/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The objective of the present study is to assess the efficacy and safety of TNK-TPA in acute ischemic stroke. A total of 75 patients will be enrolled in an open label & multi-centric clinical trial conducted across India. All the patients will receive thrombolytic therapy with TNK-TPA and appropriate background therapy. TNK-TPA will be administered in the dose of 0.2 mg/kg as IV bolus over 5-10 seconds. Neurological improvement at 24 hours as indicated by neurological improvement defined prospectively as an improvement of more than or equal to 8 points or a score of 0 on the NIH Stroke scale will be taken as primary efficacy variable. Secondary efficacy variables will be neurological improvement measured by NIH Stroke Scale at 7 days, 1 month and at 3 months & Barthel index, modified Rankin scale and Glasgow Outcome scale performed at 7 days, 1 month and 3 months. The safety variables will be percentage of patients suffering from symptomatic intracranial hemorrhage within 36 hours of treatment & percentage of patients with asymptomatic intracranial bleeding detected on CT scan at 48 hours of treatment. |