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1 Clinical Trial Details (PDF Generation Date :- Wed, 23 Jan :10:18 GMT) CTRI Number Last Modified On 29/09/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2014/06/ [Registered on: 12/06/2014] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Active Controlled Trial This study is aimed at assessing the safety of SmofKabiven Peripheral (to be registered in ) in comparison to Kabiven Peripheral (already marketed in ) in patients with gastrointestinal disorders requiring parenteral nutrition Safety and local tolerance of SmofKabiven Peripheral versus Kabiven Peripheral: An assessor-blinded, randomised, controlled, multi-centre, non-inferiority study in adult patients with gastrointestinal disorders requiring parenteral nutrition 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) SMKV-009-CP3 Version 1.1 dated 24 Jul 2013 Designation Affiliation Protocol Number Details of Principal Investigator Dr Jayashri Krishnan Deputy Head-Operations JSS Medical Research Private Limited No 13, 45th Street, Nanganallur Chennai TAMIL NADU Phone Fax Designation Affiliation jayashri.krishnan@jssresearch.com Details Contact Person (Scientific Query) Dr Sonika Newar Medical Monitor Phone Fax Designation Affiliation JSS Medical Research Private Limited 6th Floor, Vatika Mindscapes (Tower B) Plot 12/2, Sector 27D Faridabad HARYANA sonika.newar@jssresearch.com Details Contact Person (Public Query) Dr Shariq Anwar Head Operations Phone JSS Medical Research Private Limited 6th Floor, Vatika Mindscapes (Tower B) Plot 12/2, Sector 27D Faridabad HARYANA page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax Source of Monetary or Material Support > Fresenius Kabi Deutschland GmbH (Parent Company), Else-Kroener-Str. 1, Bad Homburg, Germany Type of Sponsor NIL List of Countries of Principal Investigator Primary Sponsor Details Fresenius Kabi Pvt Ltd Fifth Floor, A-wing, Ashoka Plaza, Pune-Nagar Road, Survey No. 32/2, Vadgaon Sheri, Viman Nagar, Pune , Pharmaceutical industry-global NIL of Site Site Phone/Fax/ Dr Anil Kumar Agarwal G.B. Pant Hospital Department of Gastrointestinal Surgery and Liver Transplant, Jawaharlal Nehru Marg, New Delhi New Delhi DELHI Dr Kona S Lakshmi Kumari Dr Parimal S Lawate Dr AR Nitin Rao Dr Sanjoy Mandal Dr Dinesh H Global Hospital Jehangir Clinical Development Centre Pvt. Ltd, Jehangir Hospital Premises M.S. Ramaiah Medical College and Hospitals Global Hospital, /1 to 4, Lakdi-ka-pool, Telangana State, Hyderabad Hyderabad ANDHRA PRADESH Department of gastroenterology, 32 Sassoon Road, Pune Maharashtra Pune MAHARASHTRA Department of Surgical Gastroenterology,New BEL Road, MSRIT Post, Bangalore Bangalore KARNATAKA Medica Super speciality Department of Gastroenterology, 127 EM Bypass, Mukundapur, Kolkata , West Bengal Kolkata WEST BENGAL Mysore Medical college and Research Institute anilagarwal@outlook.co m lakshmi.kona@yahoo.c om parimallawate@hotmail. com nitrao@gmail.com drsanjoymandal@gmail.com Department of Surgery, Mysore Medical College & Research Institute, drdinesh70@gmail.com page 2 / 6

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Dr Ajay Sharma Dr Hasmukh Vora Sawai Man Singh (SMS) Hospital Sheth Vadilal Sarabhai Hospital Irwin road, Mysore Mysore KARNATAKA Department of Surgical Gastroenterology, JLN Marg, Jaipur , Rajasthan Jaipur RAJASTHAN Department of Gastroenterology, Near Town Hall, Paldi Road, Ellis Bridge, Ahmedabad Ahmadabad GUJARAT asharmasgpgi@rediffm ail.com hbvora@yahoo.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Clinical Research Ethics Committee Medica Super Specialty Hospital Approved 28/07/2012 No Ethics Committee, Approved 22/05/2015 No Mysore Medical College & Research Institute Institutional Ethics Committee Maulana Azad Medical College and Associated Hospitals Institutional Ethics Committee, Smt. NHL Municipal Medical College, (NHLIEC) Institutional Ethics Committee-Global Hospitals Jehangir clinical development centre, Institutional review board M.S. Ramaiah Medical College and Hospitals Ethics Committee- Office of Ethics Committee of SMS Medical College and Attached Hospitals, Jaipur Status Approved 20/08/2014 No Approved 02/08/2014 No Approved 18/02/2015 No Approved 24/12/2013 No Approved 17/03/2014 No Approved 18/06/2014 No Date Approved/Obtained 23/05/2014 Health Type Patients Condition Adult patients with gastrointestinal disorders requiring parenteral nutrition Intervention / Type Details page 3 / 6

4 Comparator Agent Intervention SmofKabiven Peripheral emulsion for infusion Inclusion Criteria Exclusion Criteria Comparator Agent Age From Age To Gender Details Details Kabiven Peripheral emulsion for infusion Year(s) Year(s) Both Inclusion Criteria SmofKabiven Peripheral emulsion for infusion (Fresenius Kabi AB, Uppsala, Sweden); Active ingredients: essential, conditionally essential and non-essential amino acids, glucose, electrolytes, soybean oil, medium-chained triglycerides, olive oil and fish oil. Test product will be continuously infused via use of standardised peripheral venous catheters over 4-7 days at individualized daily doses Target: provision of kcal/kg body weight/day Kabiven Peripheral emulsion for infusion (Fresenius Kabi AB, Uppsala, Sweden; referred to as Kabiven Peripheral ); Active ingredients: essential, conditionally essential and non-essential amino acids, glucose, electrolytes and soy bean oil. Control product will be continuously infused via use of standardised peripheral venous catheters over 4-7 days at individualized daily doses Target: provision of kcal/kg body weight/day 1. Female or male patients of any ethnicity 2. Patient requires PN due to a gastrointestinal disorder or after elective major abdominal surgery (major abdominal surgery includes surgery for cancer and non-cancer reasons including distant metastases with completely and incompletely resectable tumors: e.g., surgery for bleeding duodenal ulcer, gastrectomy, resection of small bowel, appendectomy, splenectomy, colectomy, vascular surgery, hysterectomy, ovarectomy) 3. MELD score?7 and?29 4. Patient is expected to require PN for a minimum of 4 and maximum of 7 consecutive days 5. Patient is expected to receive?70 % of the individual energy demand by PN for a minimum of 4 days 6. Age between 18 and 65 years 7. BMI?16 and?35 kg/m2 8. Patient is capable to give Informed Consent 9. Informed Consent Form signed by the patient or an impartial witness. Exclusion Criteria 1. Elective surgeries possible interfering with the parameters important in calculating the primary outcome measure: excessive hepatectomy with less than 50% of viable tissue remaining, cholecystectomy, nephrectomy page 4 / 6

5 Method of Generating Random Sequence Method of Concealment Blinding/Masking Permuted block randomization, fixed Sequentially numbered, sealed, opaque envelopes Outcome Assessor Blinded 2. Acute organ transplantations (liver, pancreas, small bowel, kidney) 3. Patient has received PN (lipids and/ or amino acids with glucose) in the last 10 days prior to screening (the sole administration of glucose will be allowed) 4. Patient is expected to receive more than 30% of the individual energy demand by ON/EN during the first 4 days of treatment 5. Known or expected hypersensitivity to fish-, egg-, soybean-, olive or peanut protein or to any of the active substances or excipients 6. Severe renal impairment (creatinine clearance [CLCR] Severe liver insufficiency or total bilirubin 3-times higher than the upper limit of normal 9. Inborn error of amino acid metabolism 10. Present signs of acute pancreatitis as diagnosed by clinical features 11. High likelihood of severe and life-threatening complications related to initial measures in the attempt to control the underlying disease 12. Instable septic shock or any other highly vulnerable condition of the cardiovascular system, such as uncompensated cardiac insufficiency/congestive heart failure 13. Severe metabolic acidosis 14. Severe hyperlipidaemia 15. Hyperhydration or fluid overload and/or pulmonary oedema 16. Uncontrolled hyperglycaemia 17. Pathologically elevated serum levels of any of the included electrolytes 18. Haemophagocytic syndrome 19. Any serious or clinically significant condition that would preclude participation in the study (in the opinion of the investigator) 20. Patient is pregnant or lactating and intends to continue breast-feeding 21. Inadequate presentation or condition of the peripheral veins (dorsal hand, forearm, cubital veins) 22. Participation in a clinical study with an investigational drug or an investigational medical device within one month prior to start of study or during study 23. Skin alterations that could potentially interfere with adequate assessment of local skin reactions. Primary Outcome Outcome Timepoints Primary variable: The primary safety parameter will be the relative reduction of the individual Model of End Stage Liver Disease (MELD) score at the final visit versus baseline (value at Screening). The MELD score is a composite score combiningthe officially acknowledged surrogate markers for hepatic and renal function (bilirubin, INR and creatinine, respectively). Outcome: safety Metric: Model of End Stage Liver Disease (MELD) score Final visit versus pre-surgery screening visit page 5 / 6

6 Powered by TCPDF ( PDF of Trial Secondary Outcome Outcome Timepoints Individual total number of adverse events including local vein and skin reactions Severity,seriousness,clinical relevance,relatedness and outcome of AEs Various Laboratory variables at Pre surgery versus final visit lab value Total daily severity score (TSS) of local vein and local skin reactions assessed from Day 1 (baseline) to last day of vein inspection Vital signs Number of days on PN for each of the study drugs, volume administered daily allowing to calculate delivered calories Pre surgery versus final visit lab value From Day 1 (baseline) to the last day of vein inspection Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=126 Sample Size from =126 02/07/2014 No Date Specified Years=2 Months=0 Days=0 Not Applicable Completed Not Applicable This study will be a prospective, randomized, controlled, assessor blinded, multi-centre, non-inferiority clinical trial assessing the safety of the SmofKabiven Peripheral versus Kabiven Peripheral and also to assess the the local vein tolerance of the study drugs. The primary safety assessment will be the relative reduction of the individual Model of End Stage Liver Disease (MELD) score at the final visit versus baseline (Day -1).The MELD score is a combined surrogate marker for hepatic and renal function and the secondary end point includes clinical laboratory evaluation, reported adverse events, vital signs, physical examination, the total severity score (TSS) of local vein- and local skin reactions assessed from Day 1 to the last day of vein inspection and number of days on PN for each of the study drugs. page 6 / 6