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1 Clinical Trial Details (PDF Generation Date :- Fri, 22 Mar :14:34 GMT) CTRI Nuber CTRI/2010/091/ [Registered on: 29/12/2010] - Last Modified On 16/05/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randoized, Parallel Group, Multiple Ar Trial Efficacy and Safety of DEB025 Alone or Cobined With Either Ribavirin or Peg-IFN?2a in Chronic Hepatitis C Genotype 2 and 3 nae Patients A Multicenter, Randoized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regiens of DEB025 Alone or in Cobination With Ribavirin Versus Standard of Care (Peg-IFNalpha2a Plus Ribavirin) in Treatent-nae Hepatitis C Genotype 2 and 3 Patients. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (ulti-center study) CDEB025A2211 NCT Protocol Nuber ClinicalTrials.gov Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Details Contact Person (Scientific Query) Murugananthan K Head-Clinical Developent Phone Novartis Healthcare Private Liited, Medical Departent, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, urugananthan.k@novartis.co Details Contact Person (Public Query) Murugananthan K Head-Clinical Developent Novartis Healthcare Private Liited, Medical Departent, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, page 1 / 5

2 Source of Monetary or Material Support Priary Sponsor Details of Secondary Sponsor Countries of Recruitent Sites of Study Phone > Novartis Phara AG, Basel, Switzerland Type of Sponsor NIL List of Countries Australia Belgiu Canada France Gerany Italy Poland Republic of Korea Taiwan Thailand United Kingdo United States of Aerica of Principal Investigator Dr. Deepak Aarapurkar Dr. Ajit Sood Dr. Sair Shah Dr B D Goswai Dr. S. K. Sarin urugananthan.k@novartis.co Source of Monetary or Material Support Priary Sponsor Details Novartis HealthCare Pvt Ltd Medical dept, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant road, Worli, Pharaceutical industry-global of Site Site Phone// Bobay Hospital and Medical Research Centre Dayanand Medical College Diwaliben Mohanlal Mehta Charitable Trust Institute of Digestive and Liver Diseases Institute of Liver & Billary Sciences 2nd floor MRC Building,Endoscopy Departent,12 Marine Lines Tagore Nagar, Civil Lines, Ludhiana PUNJAB Khatau Mansion, Bhulabhai Desai Road, Dispur Hospitals Ltd,Ganeshguri, Guwahati Nagaon ASSAM D1 Vasant kunj,, Not Applicable aarapurkar@gail.co ajitsood10@sify.co drshahsair@gail.co bhabadev@rediffail.c o sksarin@nda.vsnl.net.in anojkuard@gail. page 2 / 5

3 Details of Ethics Coittee N/A Dr. Kaushal Madan Medanta- The Medicity Sector-38, Gurgaon HARYANA Dr. Boddu Prabhakar Dr. Philip Abraha Dr. Vinay Thorat Dr Sair Mohindra Dr. K T Shenoy Osania General Hospital P. D. Hinduja National Hospital & MRC Poona Hospital and Research Centre Sanjay Gandhi Post graduate Institute of Medical Science Sree Gokula Medical College and Research Foundation Afzalgunj, Hyderabad ANDHRA PRADESH Research Dept,Veer Savarkar Marg, Mahi , Sadashiv Peth, Pune Raebarelli Road, Lucknow UTTAR PRADESH Dept of Gastroenterolo gy,venjaraoodu Not Applicable N/A co k_adan_2000@yahoo.co ? dr_pabraha@hinduja hospital.co drvinaythorat@gail.co dr.ktshenoy@gail.co of Coittee Approval Status Date of Approval Is Independent Ethics Coittee? Bobay Hospital Ethic Coittee Ethics coittee Dispur Hospitals ltd Ethics coittee P.D. Hinduja National Hospital & Medical Research centre Ethics Coittee, Osania Medical College Ethics Coittee, Poona Hospital and Research Centre Independent Ethics Coittee, Coittee, Lucknow Coittee, New Delhi Coittee,Sanjay Gandhi PG Institute od Medical Sciences Medanta Independent Ethic Coittee Sree Gokula Medical College and Resarch Approved 28/02/2011 No Approved 17/01/2011 No Approved 24/02/2011 No Approved 07/02/2011 No Approved 28/04/2011 No Approved 31/12/2010 Yes Approved 15/02/2011 No Approved 20/12/2010 No Approved 03/03/2011 No Approved 14/02/2011 Yes Approved 27/01/2011 No page 3 / 5

4 Regulatory Clearance Status fro DCGI Health Condition / Probles Studied Intervention / Coparator Agent Inclusion Criteria Foundation Ethical Coittee Status Date Approved/Obtained 14/12/2010 Health Type Patients Condition Hepatitis C Chronic Type Details Intervention DEB illigra QD + RBV 400 illigra BID orally, for 52 weeks Intervention DEB illigra QD + RBV 400 illigra BID Intervention DEB illigra QD Intervention DEB illigra QD + peg-ifnalpha2a once weekly Coparator Agent peg-ifnalpha2a once weekly plus RBV 400 g BID Age Fro Age To Gender Details Year(s) Year(s) Both Inclusion Criteria Chronic hepatitis C viral Plasa HCV RNA level lower liit? IU/l assessed by qpcr (quantitative polyerase chain reaction) or equivalent at screening; no upper liit; HCV genotype 2 or 3; No previous treatent for Hepatitis C infection Exclusion Criteria Details Exclusion Criteria Patients with evidence of Cirrhosis at the tie of screening. Patients with evidence of Hepatocellular carcinoa at the tie of screening. Any other cause of relevant liver disease other than HCV. 4. ALT greater than or equal to 10 ties ULN. Other protocol-defined inclusion/exclusion criteria ay apply Method of Generating Rando Sequence Method of Concealent Blinding/Masking Coputer generated randoization Centralized Open Label Priary Outcoe Outcoe Tiepoints Measure: RVR : Rapid Viral Response : defined as seru HCV RNA undetectable (by LOQ) after 4 weeks of treatent. 4 weeks Secondary Outcoe Outcoe Tiepoints Target Saple Size Measure: SVR24 : Sustained Viral Response Week 24 : defined as seru HCV RNA undetectable (by LOD) after 24 weeks of treatent. Total Saple Size=340 Saple Size fro =65 24 weeks page 4 / 5

5 Powered by TCPDF ( Phase of Trial Phase 2 Date of First Enrollent () Date of First Enrollent (Global) Estiated Duration of Trial Recruitent Status of Trial (Global) Recruitent Status of Trial () Publication Details Brief Suary 21/01/ /10/2010 Years=1 Months=7 Days=0 Copleted Copleted No Publication provided. Purpose of the Study: The study is to investigate whether DEB025 alone or in cobination with either ribavirin or peg-ifn?2a is ore efficient copared to SOC in treatent-nae patients with HCV genotype 2 and 3. In addition, triple therapy with DEB025 plus SOC will be applied to patients not achieving RVR in the different ars. FPFV for : 21 Jan 2011 Target enrollent for : 65 page 5 / 5