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1 Clinical Trial Details (PDF Generation Date :- Tue, 05 Mar :43:01 GMT) CTRI Number CTRI/2010/091/ [Registered on: 05/10/2010] - Last Modified On 07/03/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randized, Parallel Group, Placebo Controlled Trial A clinical trial to study the safety and efficacy of Ferumoxytol for the treatment of Iron Deficiency Anemia A Phase III, Randized, Double-Blind, Placebo-Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) AMAG-FER-IDA-301 NCT Designation Affiliation Protocol Number ClinicalTrials.gov Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Dr Sushant Sehrawat Sr. Clinical Research Physician Phone Fax Designation Affiliation ICON Clinical Research India Pvt Ltd, Campus 3A, 2nd Floor, RMZ Millenia Business Park, #143, Dr. M. G. R. Road, Kandanchavdy, Chennai India Sushant.Sehrawat@iconplc.c Details Contact Person (Public Query) John Luke Associate Director CTM CR Phone ICON Clinical Research India Pvt Ltd ICON Clinical Research India Pvt Ltd, Sharada Towers, 2nd Floor, Nandidurg Road, India page 1 / 7

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 > AMAG Pharmaceuticals, Inc.(Sponsor) 100, Hayden Ave, Lexington, MA 02421, USA Type of Sponsor ICON Clinical Research India Pvt Ltd List of Countries India of Principal Investigator Dr P Muralikrishna Dr M K Ramesh Dr Abhijit Chandra Dr Unmesh Vidyadhar Takalkar Dr Rajnish Nagarkar Dr Balasubramanian Sivanesan Primary Sponsor Details AMAG Pharmaceuticals Inc Sponsor 100, Hayden Ave, Lexington, MA 02421, USA Pharmaceutical industry-global Campus 3A, 2nd Floor, RMZ Millenia Business Park, #143, Dr. M. G. R. Road, Kandanchavdy, Chennai , Tamil Nadu, India of Site Site Phone/Fax/ Andhra Medical College HOD & prof. of Gastroenterology, Department of Gastroenterology, Andhra Medical College, King George Hoapital, Visakhapatnam ANDHRA PRADESH Medical College and Research Institute Chhatrapati Shahuji Maharaj Medical University CIIGMA Institute of Medical Sciences PVT. LTD. Curie Manavata Cancer Centre G. Kuppusamy Naidu Memorial Prof. general Surgery, K. R. Road, Fort,560002, Prof. & Head, Department of Surgical Gastroenterology, Lucknow , Uttar Pradesh, India Lucknow UTTAR PRADESH Consultant, Dept. of Gastroenterologist, No. 3, Raghuveer Nagar, Opp. SFS High School, Jalna Road, , Aurangabad Opp. Mahamarg Bus Stand, Mumbai Naka, Nashik muralikrishna63@yaho o.c drmkramesh@gmail.co m abhijitchandra@hotmail.c unmesh_3@sancharnet.c drraj@manavatacancer centre.c Consultant, Dept. of oncology, Nethaji Road, Pappanaickenpalayam, sivanesan@jipmer.net Coimbatore page 2 / 7

3 Dr Ravikumar Saxena Global s Consultant Haematologist & Medical ravikumar1960@hotmai Oncologist,# / 1 l.c to 4, Lakdikapool, Hyderabad ANDHRA PRADESH Dr Bhabadev Goswami Dr Suchitra Thunga Dr Srivenu Itha Dr J S Rajkumar Dr Asha Swarup Dr Sandeep Kumar Gupta Dr Kirushna Kumar Kosanam Subramanian Dr Rajendra Kashinath Shimpi Dr Vinay K Thorat Institute of Digestive Director, Ganeshguri, and Liver Diseases Guwahati Dispur s Pvt Ltd Goalpara ASSAM Kasturba Medical College Krishna Institute of Medical sciences LifeLine Multi Specialty M S Ramaiah Medical College and s M. V. and Research Centre Meenakshi Mission and Research Centre Noble Poona and Research Centre Department of OBG, N. G. Road,,Attavar, Consultant Gastroentrologist, /1, Minister Road, Secunderabad Hyderabad ANDHRA PRADESH Chairman & Cheif Surgeon, No. 5/639, Rajiv Gandhi Salai (OMR), Perungudi, Chennai , Tamil Nadu, India Chennai Prof., Dept. of Obstetrics & Gynecology, MSR Nagar, MSRIT Post,,New BEL Road, Director, No. 314/30, Mirza Mandi, Chowk, Lucknow UTTAR PRADESH Dept. of Clinical Oncology, Lake Area,,Melur Road, Madurai bhabadev@rediffmail.c sthunga@yahoo.co.in srivenu_aiims@yahoo.c drjsrajkumar2010@gma il.c ashaswarupov@gmail.c sandeepkumar.gupta@ rediffmail.c drkskk@yahoo.c Consultant Uro-Andrologist, Magarpatta City rkshimpi@vsnl.net Road,Hadapsar, Pune Consultant, Dept. of Gastroenterologist, No. 27, Sadashiv Peth, drvinaythorat@gmail.co page 3 / 7

4 Details of Ethics Cmittee 030 Pune Dr Anish Maru S. K. Soni Senior Consultant, Medical Oncologist & Director, Sector - 5, Vidhyadhar Nagar, Sikar Road Jaipur RAJASTHAN Dr Mukesh Kalla Dr Rajasi Shantanu Sengupta Dr Anita Ramesh S. R. Kalla Memorial Gastro and General Sengupta and Research Institute Sri Ramchandra Medical Centre Director, No#78, Dhuleshwar Garden, Behind HSBC Bank, Sardar Patel Marg, C Scheme, Jaipur RAJASTHAN Consultant obstetrician & Gynaecologist, Dept of Gynaecologist, Ravinagar Square, Nagpur Prof. Medical oncology, Medical oncology unit, No.1, Ramachandra Nagar, Porur, Chennai m dranishmaru@searoc.c o.in drmkalla@rediffmail.co m rajasisengupta@gmail.c Anitachandra100@hot mail.c of Cmittee Approval Status Date of Approval Is Independent Ethics Cmittee? Ethical Review Board, Approved 19/08/2010 Yes Ethical Review Board, M S Ramaiah Medical College and Teaching Ethics Cmittee of Medical College and Research Institute Ethics Cmittee Poona and Research Centre Approved 31/08/2010 Yes Approved 08/07/2011 Yes Approved 02/07/2011 Yes Ethics Cmittee, Approved 23/06/2011 Yes Dispur s Pvt Ltd Ethics Cmittee, Kodlikeri Memorial (K.M.H) & CIIGMA Ethics Cmittee, Lifeline Multispeciality Global Health Concern Ethics Cmittee Human Research Ethics Cmittee Approved 12/06/2010 Yes Approved 12/07/2011 Yes Approved 02/06/2010 Yes Approved 25/05/2011 Yes page 4 / 7

5 Regulatory Clearance Status fr DCGI Health Condition / Problems Studied Intervention / Cparator Agent Instititional Ethics cmittee, Sri Ramchandra Medical Cetntre Cmittee, Andhra Medical College Cmittee, G. Kuppusamy Naidu Memorial Cmittee, Global s Cmittee, Kasturba Medical College Cmittee, Krishna Institute of Medical sciences Cmittee, M. V. and Research Centre Cmittee,Chhatrapati Shahuji Maharaj Medical University Manavata Clinical Research Institute Professional Ethics Cmittee Noble Cmittee S. R. Kalla Memorial Ethical Cmittee for Human Research SEAROC Ethics Cmittee Status Approved 22/09/2010 Yes Approved 05/08/2011 Yes Approved 28/10/2010 Yes Approved 28/05/2011 Yes Approved 06/07/2010 Yes Approved 01/07/2011 Yes Approved 10/04/2011 Yes Approved 29/12/2010 Yes Approved 29/09/2010 Yes Approved 27/08/2010 Yes Approved 07/06/2010 Yes Approved 13/11/2010 Yes Date Approved/Obtained 29/09/2010 Health Type Patients Condition Subjects with Iron Deficiency Anemia based on laboratory tests and a history of unsatisfactory oral iron therapy or in wh oral iron cannot be used Type Details Intervention Ferumoxytol I.V. injection of ferumoxytol 510 mg (17 ml) at Baseline (Day 1) with a second dose 2 to 8 days after Dose 1, for a total cumulative dose of 1.02 g Cparator Agent Placebo I.V. injection of placebo (17 ml page 5 / 7

6 Inclusion Criteria Age Fr Age To Gender Details Inclusion Criteria Year(s) Year(s) Both 1. Subjects with IDA normal saline) at Baseline (Day 1) with a second injection 2 to 8 days after the first injection 2. Subjects who have a history of unsatisfactory oral iron therapy or in wh oral iron cannot be used 3. Female subjects of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until cpletion of participation in the study Exclusion Criteria Method of Generating Rand Sequence Method of Concealment Blinding/Masking Details Cputer generated randization Not Applicable Exclusion Criteria Participant, Investigator and Outce Assessor Blinded 1. History of allergy to IV iron 2. Allergy to two or more classes of drugs 3. Subjects on dialysis or with an estimated glerular filtration rate (egfr) <30 ml/min/1.73 m2 4. Female subjects who are pregnant or intend to bece pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test 5. Hemoglobin </=7.0 g/dl 6. Serum ferritin level >600 ng/ml Primary Outce Outce Timepoints Hemoglobin changes 5 weeks Secondary Outce Outce Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary Patient reported outces Total Sample Size=800 Sample Size fr India=112 21/12/ /06/2010 Years=1 Months=6 Days=0 Cpleted Other (Terminated) none yet 5 Weeks This is a Phase III study to assess the safety and efficacy of ferumoxytol cpared with placebo for the treatment of Iron Deficiency Anemia. Subjects in the ferumoxytol treatment group will receive an IV injection of ferumoxytol 510 mg on Day 1 with a second dose 2 to 8 days after Dose 1. Subjects assigned to the placebo arm will receive 17 ml of normal saline on Day 1 with a second injection 2 to 8 days after the first. The primary outce will be the proportion of subjects achieving a >/=2.0 page 6 / 7

7 Powered by TCPDF ( g/dl increase in hemoglobin at any time fr Baseline to Week 5. Anticipated date of enrollment for the Indian Arm is 30 Oct subjects are proposed to be enrolled fr India page 7 / 7