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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Sat, 02 Oct 2021 21:08:26 GMT) CTRI Number CTRI/2017/09/009748 [Registered on: 13/09/2017] - Trial Registered Prospectively Last Modified On 13/08/2021 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Placebo Controlled Trial Public Title of Study Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohns Disease Scientific Title of Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy Study and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Secondary IDs if Any Secondary ID Identifier 2016-001367-36 EudraCT NCT02914561 ClinicalTrials.gov Details of Principal Details of Principal Investigator Investigator or overall Name Trial Coordinator (multi-center study) Designation Affiliation Address Phone Fax Email Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Vaishali Karadkar Query) Designation Medical Monitor Affiliation Klinera Corporation India Address Klinera Corporation India, 401, Hill View Industrial Estate, LBS Marg,Ghatkopar West, Mumbai 400 086 Mumbai MAHARASHTRA 400086 India Phone 912225091470 Fax 912225091476 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Kalpesh Vispute Designation Clinical Project Manager Affiliation Klinera Corporation India Address Klinera Corporation India, 401, Hill View Industrial Estate, LBS Marg,Ghatkopar West, Mumbai 400 086 Mumbai MAHARASHTRA 400086 India page 1 / 17 PDF of Trial CTRI Website URL - http://ctri.nic.in Phone 912225091470 Fax 912225091476 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Gilead Sciences Inc, 333 Lakeside Drive Foster City, CA 94404, USA Primary Sponsor Primary Sponsor Details Name Gilead Sciences Inc Address 333 Lakeside Drive Foster City, CA 94404, USA Type of Sponsor Pharmaceutical industry-Global Details of Secondary Name Address Sponsor Klinera Corporation India Klinera Corporation India 401 Industrial Hill View Ghatkopar west, Mumbai-400086 Countries of List of Countries Recruitment Argentina Australia Austria Belgium Bulgaria Canada Croatia Czech Republic France Georgia Germany Greece Hong Kong Hungary Iceland India Ireland Israel Italy Japan Malaysia Mexico Netherlands New Zealand Norway Poland Portugal Republic of Korea Romania Russian Federation Serbia Singapore Slovakia South Africa page 2 / 17 PDF of Trial CTRI Website URL - http://ctri.nic.in Spain Sri Lanka Sweden Switzerland Taiwan Ukraine United Kingdom United States of America Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Vineet Ahuja All India Institute of Dept. of 91-1126588500 Medical Sciences Gastroenterology,Room No.3093, third [email protected] floor,New m Delhi-110029, India New Delhi DELHI Dr Shine Sadasivan Amrita Institute of Amrita Institiute of 91-9497556339 Medical Science and Medical Science and Research Center Research Center, [email protected] Amrita Lane, ta.edu Elamakkara P O Edappally, Kochi, Ernakulam, Kerala, India Ernakulam KERALA Dr Mahesh Kumar Apollo Gleneagles Institute of 91-3323205218 Goenka Hospitals Gastrosciences Day Care Building, 4th doctormaheshkumargo Floor, Apollo [email protected] Gleneagles Hospitals, 58 Canal Circular Road, Kolkata- 700054, West Bengal, India Kolkata WEST BENGAL Dr Ganesh Apollo Speciality Dept. of 91-4424334455 Subramanian Hospital Gastroenterology, No: 320, Padma complex, [email protected] Anna salai, om Chennai-600035, Tamil Nadu,India Chennai TAMIL NADU Dr Rupa Banerjee Asian Institute of Department of 91-23324255 Gastroenterology Gastroenterology, Asian Institute of Gastro dr_rupa_banerjee@hot enterology,6-3-661, mail.com Somajiguda, Hyderabad, Telangana 500082 Hyderabad ANDHRA PRADESH Dr Ravishankar Reddy Aware Global Hospital Aware Global Hospital, 91-3848407907 8-16-1, Inner Ring Rd, Laxmi Enclave, [email protected] page 3 / 17 PDF of Trial CTRI Website URL - http://ctri.nic.in Ramakrishnapuram, LB om Naga, Hyderabad, Telangana, India Hyderabad ANDHRA PRADESH Dr Kiran Kumar Jadhav B J Medical College & B.J. Medical College & 91-9823949126 Sassoon G Hospital Sassoon G. Hospital 91-20-26126868 ,Sassoon Road,Pune-4 [email protected] 11001,Maharashtra,Indi a Pune MAHARASHTRA Dr Samit Jain B.Y.L Nair CH Hospital Department of 91-2223021168 and T.N Medical Gastroenterology, New College OPD Building, 7th [email protected] Floor, Room no. 717, B.Y.L Nair CH Hospital and T.N Medical College, Dr. A. L. Nair Road, Mumbai-400008, Maharashtra, India. Mumbai MAHARASHTRA Dr Parshottam Koradia BAPS Pramukh Swami Adajan Char Rasta, 91-9825312027 Hospital Surat- 395009. Surat Purushottam_koradia@ GUJARAT yahoo.co.in Dr_Abhiram_Kognati Citizens Hospital 7th floor, Citizens 919849050950 Hospital, Near Aparna 914067191919 Sarovar, Nallagandla, kogantiabhiram@gmail. Serlingampally, com Hyderabad Hyderabad TELANGANA Dr Ajit Sood Dayanand Medical Dept. of 91-1614688800 College & Hospital Gastroenterology, Tagore Nagar, Civil [email protected] Lines, Ludhiana-141001, Punjab, India Ludhiana PUNJAB Dr Aejaz Habeeb Deccan College of Dept. of 91-4024340169 Medical Gastroenterology Sciences,Owaisi ,Kanchan bagh,Hydera aejazhabeeb@hotmail. Hospital& Reaserch bad-500058,Telangana, com Centre India Hyderabad ANDHRA PRADESH Dr Vinay Kumar Department of Post Department of Post 91-8008177113 Graduate Medicine, Graduate Medicine,GSVM dr.vinaysachan@gmail. Medical College,Kanpur com -208002,Uttar Pradesh,India Kanpur Nagar UTTAR PRADESH Dr Yogesh Batra Dr. B. L. Kapur Dr. B. L. Kapur 91-1130403040 Memorial Hospital Memorial Hospital, page 4 / 17 PDF of Trial CTRI Website URL - http://ctri.nic.in Pusa Road, New Delhi, [email protected] Delhi, India om New Delhi DELHI Dr S K Acharya Fortis Flt. Lt. Rajan Dept. of 91-1142776222 Dhall Hospital Gastroenterology, Sector B, Pocket 1, [email protected] Aruna Asaf Ali om Marg,Vasant Kunj, New Delhi, Delhi-110070, , India New Delhi DELHI Dr Mohinish Chhabra Fortis Hospital Fortis Hospital,Mohali,S 91-9814057593 ector-62,Phase-8,Mohal i-160062,Punjab,India chhabramohinish@gma Chandigarh il.com CHANDIGARH Dr Gourdas Choudhuri Fortis Memorial Fortis Memorial 91-01244962227 Research Institute Research Institute,Sector - 44, choudhuri.gour@gmail. Opposite HUDA City com Centre, Gurugram, Haryana 122002 Gurgaon HARYANA Dr Amarender S Puri G.B Pant Hospital Room No. 201, 91-23233001 Department of Gastroenterology, amarender.puri@gmail. Academic Block, G.B com Pant Hospital , New Delhi- 110002, Delhi, India. New Delhi DELHI Dr P Shravan Kumar Gandhi Hospital New Bhoiguda Road, 91-4027505566 5th Floor, Department of Gastroenterology,Se [email protected] cunderabad- 500003 om Telangana, India. Hyderabad ANDHRA PRADESH Dr Ravindra Gaadhe Gastroplus Digestive D-Block 3rd Floor, 91-9276558517 Disease Centre Pvt. Galaxy Bazar, Sunrise Ltd. Park Road, Vastrapur, gaadheravindra@yahoo Ahmedabad-380054, .co.in Gujarat India Ahmadabad GUJARAT Dr_Rami Reddy Gleneagles Global Gleneagles Global 919815192032 Hospitals Hospitals, 6-1-1070/1 to 914023244444 4, Lakdikapul, Opposite [email protected] Dwarka Hotel- 500004, Hyderabad, India Hyderabad TELANGANA Dr Adharsh C K Global Hospital Dept. of 919844136480 Gastroenterology, 67 918026255555 Uttarahall, Main Road, [email protected] page 5 / 17 PDF of Trial CTRI Website URL - http://ctri.nic.in Kengeri Bengaluru-560060, Karnataka, India Bangalore KARNATAKA Dr Nitin Pai Grant Medical Dept. of 91-2066455100 Foundation Ruby Hall Gastroenterology, 40 Clinic Sassoon Road ,Pune [email protected] ,Maharashtra-411001, India Pune MAHARASHTRA Dr BD Goswami Institute of digestive Institute of digestive 91-3612221962 and liver disease, and liver disease, Dispur Hospitals Pvt Ltd Dispur Hospitals Pvt [email protected] Ltd, Ganeshguri, om Guwahati: 781 006, Assam, India Kamrup ASSAM Dr Venkateswaran Institute of Medical Institute of Medical 91-7904285567 Arcot Rajeshwaran Gastroenterology, Gastroenterology, 91-44-25363970 RGGGH, Madras RGGGH, MMC, dr.venkateswaranar@g Medical College Chennai-600003, Tamil mail.com Nadu, India, Chennai TAMIL NADU Dr Gopal Krishna Dhali Institute of Post School of Digestive & 91-3322235181 Graduate Medical Liver Diseases, Institute Education and of Post Graduate [email protected] Research Medical Education and Research, Ronald Ross building, 4th floor, Room No- 17, 244 AJC bose road ,Kolkata- 700020, West Bengal, India Kolkata WEST BENGAL Dr Atul Shah Kaizen Hospital Institute of 91-7927914444 Gastroenterology and Research Centre, 132 [email protected] Feet Ring Road, Near m Helmet Circle, Ahmedabad – 380052, Gujarat, India Ahmadabad GUJARAT Dr Shiran Shetty Kasturba Medical Dept. of 918861920517 College Hospital Gastroenterology, Mani 91820-2922928 pal,Karnataka-576104, [email protected] India Udupi KARNATAKA Dr V Tantry Kasturba Medical Dept. of 91-8242445858 College Hospital Gastroenterology, Ambedkar Circle, [email protected] Mangalore-575001, Karnataka, India page 6 / 17 PDF of Trial CTRI Website URL - http://ctri.nic.in Udupi KARNATAKA Dr Ajay Kumar King George Medical King George Medical 91-9455519306 University University ,Department 91-522-2257539 of Surgical drajaymd12345@gmail. Gastroenterology,King
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