Clinical Trial Details (PDF Generation Date :- Fri, 08 Mar 2019 17:21:25 GMT) CTRI Number CTRI/2009/091/000251 [Registered on: 24/06/2009] - Last Modified On 29/12/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Biological Single Arm Trial Clinical trial to assess the efficacy and safety of TNK-TPA in Acute Ischemic Stroke Clinical trial to assess the efficacy and safety of TNK-TPA in Acute Ischemic Stroke Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) GBL/TNK-TPA/AIS/002 NIL Designation Affiliation Phone Fax Email Designation Affiliation Protocol Number NIL Details of Principal Investigator Dr Sandeep Sonawane Manager Emcure Pharmaceuticals Ltd. 255/2 Hinjwadi, Phase-I 411057 sandeep.sonawane@emcure.co.in Details Contact Person (Scientific Query) Dr Sandeep Sonawane Phone 020-39821000 Fax 020-39821019 Email Designation Affiliation Emcure Pharmaceuticals Ltd 255/2, Phase I, Hinjwadi 411057 Sandeep.Sonawane@emcure.co.in Details Contact Person (Public Query) Dr Sandeep Sonawane Manager- Medical, Emcure Pharmaceuticals Ltd 255/2, Phase I, ITBT PArk, Hinjwadi 411057 Phone 020-39821000 page 1 / 6
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax 020-39821019 Email > Gennova Biopharmaceuticals Limited, Type of Sponsor List of Countries of Principal Investigator Sandeep.Sonawane@emcure.co.in Source of Monetary or Material Support Primary Sponsor Details Gennova Biopharmaceuticals Limited Hinjwadi, Pharmaceutical industry-n of Site Site Phone/Fax/Email Dr. K. Abdul Salam Baby Memorial Hospital I G Road,-673 004 N/A Dr. Deepak Namjoshi Criticare Hospital,-m Mumbai Dr. K. K. Nirmal Raj Dhanalakshmi Hospital,-670002 Kannur Dr B. Raghunath Elite Hospital P.B.No.1414, P.O.Koor kenchery,-680007 Thrissur Dr. Barmare Shahid Kurza Nursing Home,- Mumbai Dr. Deepak Sitaram Laddhed Dr. R. Srinivasa Laddhed Hospital M.S. Ramaiah Memorial Hospital Dr. Shankara Nellikunja Mallikatta Neurocentre Dr. P.H.A. Majeed Wankhede layout,-422001 N/A Bangalore,-560 054 Bangalore KARNATAKA Opp. Mallikatta Circle, Kadri, mallikatta,-575002 Bangalore KARNATAKA Mother Hospital Pvt Ltd Olari,-680012 Thrissur Dr. Indraneel Basu Popular Hospital Kakarmatta,-221109 Varanasi UTTAR PRADESH Dr. Shirish D Deshpande Rajebahadar Hospital 13-14/199, and research center Pvt Rajebahadar, Tilak Ltd road,-422001 Nashik drasv@rediffmail.com page 2 / 6
Details of Ethics Committee Dr. R. S. Wadia Ruby Hall Clinic,- Dr. Vijay Dhonge Dr. K.Asokan Shreeji Multipeciality hospital and clinical research center Sri Ramakrishna Hospital Castle Rock, near Canada corner signal, Opp. Vishwas Bank,-422005 Nashik No 395, Avarampalayam Road,Sarojini Naidu Road, Sidhapudur-641044 Coimbatore TAMIL NADU Dr.Vikram Sharma St.Theresa's Hospital Erragadda, Sanath Nagar,-500018 Hyderabad ANDHRA PRADESH Dr. Zubin Vaid UNIQUE Hospital and polyclinic, Jamuna appt, 1st Floor, S.V. Road,Andheri (W)-400056 Mumbai Dr. M Pradeep WELCARE Hospital Pirayari Junction,-679312 Palakkad pmrf@giaspn01.vsnl.ne t.in of Committee Approval Status Date of Approval Is Committee? BABY Memorial Hospital Ethics committee for Dr. K. Abdul Salam Ethics ST. THERESA?S Hospital for Dr. Vikram Sharma for Dr. B. Raghunath for Dr. Deepak S. Laddhed for Dr. Indraneel Basu for Dr. K. Asokan page 3 / 6
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria for Dr. K.K.Nirmal Raj for Dr. M. Pradeep for Dr. P.H.A. Abdul Majeed for Dr. Shirish Deshpande Kotbagi Hospital- Independant Ethics Committee for Dr. Deepak Namjoshi Kotbagi Hospital- Independant Ethics Committee for Dr. Shahid Barmare Kotbagi Hospital- Independant Ethics Committee for Dr. Zubin Vaid M.S.Ramaiah Medical college and Teaching Hospital Ethical Review Board For Dr. R. Srinivasa Mallikatta Ethics committee for Dr. Shankara Nellikunja Poona Medical Research Foundation for Dr R.S. Wadia SMIRC - EC for Dr. Vijay Dhondge Status Approved/Obtained Health Type Patients Date No Date Specified Condition Acute Ischemic Stroke Type Details Intervention Tenecteplase (TNK-TPA) Injection Tenecteplase (TNK-TPA)0.1 or 0.2 mg/kg IV bolus Comparator Agent NIL NIL Age From Age To Gender 18.00 Day(s) 75.00 Year(s) Both Inclusion Criteria page 4 / 6
Details 1. 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 consent before study procedure Exclusion Criteria Details Exclusion Criteria 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 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 Method of Concealment Blinding/Masking An Open list of random numbers Open Label Primary Outcome Outcome Timepoints Neurological improvement at 24 hours as indicated by neurological improvement of more than or equal to 8 points or a score of 0 on the NIH Stroke scale 0 and 24 hours Secondary Outcome Outcome Timepoints Target Sample Size Neurological improvement measured by NIH Stroke Scale at 7 days, 1 month and 3 months Total Sample Size=50 Sample Size from =50 Phase of Trial Phase 2/ Phase 3 Date of First Enrollment () Date of First Enrollment (Global) 25/06/2009 No Date Specified 0, 7, 30 and 90 days page 5 / 6
Powered by TCPDF (www.tcpdf.org) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Years=0 Months=3 Days=0 Completed nil The objective of the present study is to evaluate the efficacy and safety of Tenecteplase (TNK-TPA) in the treatment of acute ischemic stroke at the doses of 0.1 mg/kg and 0.2 mg/kg. This will be an open label, randomized, multi-centric clinical trial conducted in 50 patients at neurology centers across. Patients with acute ischemic stroke with serious measurable deficit on National Institute of Health Stroke Scale (NIHSS) within 3 hours of onset, aged 18-75 years will be enrolled. Patients recovering from stroke, with any bleeding disorder, on anticoagulant therapy, with uncontrolled hypertension, myocardial infarction, seizures, pre-existing neurological or psychiatric disease and pregnant patients will be excluded from the study. Patients will be randomized to receive either the dose of 0.1 mg/kg or 0.2 mg/kg. Tenecteplase will be administered as an IV bolus over 5-10 seconds within 3 hours of onset of stroke. The primary efficacy variable will be neurological improvement at 24 hours as indicated by neurological improvement of? 8 point or a score of 0 on the NIH Stroke scale. This will be expressed as percentage of responders and will be compared. The secondary efficacy variables will be neurological improvement measured by NIH Stroke Scale, Barthel index, modified Rankin scale and Glasgow Outcome scale measured 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 and percentage of patients with asymptomatic intracranial bleeding detected on CT scan at 48 hours of treatment. The safety variables will be analyzed using percentages and proportions. For all statistical tests a p-value of? 0.05 will be considered as significant. page 6 / 6