PDF of Trial CTRI Website URL -

Transcription

1 Clinical Trial Details (PDF Generation Date :- Wed, 10 Apr :29:54 GMT) CTRI Number Last Modified On 02/11/2011 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/11/ [Registered on: 02/11/2011] - Trial Registered Retrospectively No Interventional Biological Non-randomized, Multiple Arm Trial Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rfviiifc) in Subjects With Severe Hemophilia A An Open-Label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rfviiifc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia A 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) 997HA301, Ver2, Dated 13 Dec 2010 EUDRA CT No: DCGI EudraCT Details of Principal Investigator Dr Alok Srivastava Country PI Head of Department Phone Fax Deparment of Hematology CMC,, TAMIL NADU aloks@cmcvellore.ac.in Details Contact Person (Scientific Query) Dr Anjali Nagpal Medical & Scientific Lead Biogen Idec Phone Fax Biogen Idec Biotech Pvt Ltd Vatika Towers, B Block, 14th Floor Sector 54, Golf Course Sector Road Gurgaon Gurgaon HARYANA anjali.nagpal@biogenidec.com Details Contact Person (Public Query) Dr Ritika Bajaj Head, Clin Ops Biogen Idec Biogen Idec Biotech Pvt Ltd Vatika Towers, B Block, 14th Floor Sector 54, Golf Course Sector Road Gurgaon Gurgaon HARYANA page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > Biogen Idec Ltd Innovation House Norden Road Maidenhead Berkshire United Kingdom SL AY Innovation House 70 Norden Road Maidenhead, Berkshire United Kingdom SL6 4AY Type of Sponsor Biogen Idec Biotech Pvt Ltd List of Countries Australia Austria Belgium Brazil Canada Chile China France Germany Hong Kong Italy Japan New Zealand Poland Russian Federation South Africa Spain Sweden Switzerland United Kingdom United States of America of Principal Investigator Primary Sponsor Details Biogen Idec Ltd Innovation House Norden Road Maidenhead Berkshire United Kingdom SL AY Innovation House 70 Norden Road Maidenhead, Berkshire United Kingdom SL6 4AY Pharmaceutical industry-global Biogen Idec Biotech Pvt Ltd 14th Floor Vatika Towers Golf Course Road Sector 54 Gurgaon Haryana of Site Site Phone/Fax/ Dr Joseph John CMC Ludhiana Department of Hematology and Bone Marrow Transplant, Christian Medical College &, Brown Road, Ludhiana, INDIA. Ludhiana m page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent PUNJAB Dr Alok Srivastava CMC Department of Haematology, Christian Medical College, , TAMIL NADU Dr Naresh Gupta Dr Shashikant Apte Dr Cecil Ross Maulana Azad Medical College & Lok Nayak Sahyadri Speciality St. Johns Medical College, Haemophilia Day care Centre, Maulana Azad Medical College & Lok Nayak, New Delhi,. Central DELHI Department of Hematology, Sahyadri Speciality, Karve Road, Plot no.30 C, Erandwane, Deccan Gymkhana, Pune Pune MAHARASHTRA aloks@cmcvellore.ac.in doctornaresh@nic.in shashikant.apte@gmail. com St. Johns Medical College, Department of Medicine cecilross@sify.com (Haematology), Sarjapur Road Bangalore, Bangalore KARNATAKA of Committee Approval Status Date of Approval Is Independent Ethics Committee? Insitutional Ethics Commitee, St. Johns Institiute Ethics Commitee, CMC Ludhiana Commitee Committee, CMC Committee, MAMC, New Delhi Status Approved 28/04/2011 No Approved 21/09/2011 No Approved 10/05/2011 No Approved 30/09/2011 No Approved 03/10/2011 No Date Approved/Obtained 25/08/2011 Health Type Patients Condition Severe Haemophilia A Type Details Comparator Agent Nil Nil Intervention Arm 1 - Tailored Prophylaxix Regimen Prophylactic Treatment with rfviii IU/kg. 52 Weeks page 3 / 5

4 Inclusion Criteria Intervention Arm 2 - Weekly Dosing Regimen Prophylactic treatment with 65 IU/kg fixed dose, weekly regimen. 52 Weeks Intervention Arm 3 - On Demand Regimen Subjects to be treated with IU/kg depending upon the severity of the bleed. Patient to treat bleeds as they occur for 52 Weeks. Age From Age To Gender Year(s) Year(s) Male Inclusion Criteria Details Male, greater than or equal to 12 years of age and weigh at least 40 kg Diagnosed with severe hemophilia A defined as 1 IU/dL (1%) endogenous Factor VIII) History of at least 150 documented prior exposure days to any Factor VIII product Platelet count greater than or equal to 100,000 cells/micro L Note: As per DCGI approval, lower age limit in INDIA is 18 years Exclusion Criteria Details Exclusion Criteria History of Factor VIII inhibitors Kidney and liver dysfunction Diagnosed with other coagulation disorder(s) other than hemophilia A Prior history of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration Method of Generating Random Sequence Method of Concealment Blinding/Masking Not Applicable Not Applicable Open Label Primary Outcome Outcome Timepoints Clinically notable changes from baseline in Clinically notable changes from baseline in physical examinations, vital signs, lab values, physical examinations, vital signs, lab values, and incidence of AEs and inhibitor development [ and incidence of AEs and inhibitor development [ Time Frame: 156 weeks ] [ Designated as safety Time Frame: 156 weeks ] [ Designated as safety Annual number of bleeding episodes (spontaneous and traumatic) [ Time Frame: 156 weeks ] [ Designated as safety Annual number of bleeding episodes (spontaneous and traumatic) [ Time Frame: 156 weeks ] [ Designated as safety Secondary Outcome Outcome Timepoints Total annualized rfviiifc consumption per subject [ Time Frame: 156 weeks ] [ Designated as safety Evaluation of PK parameter estimates of rfviiifc and rfviii [ Time Frame: 156 weeks ] [ Designated as safety [ Time Frame: 156 weeks ] [ Designated as safety page 4 / 5

5 Powered by TCPDF ( Evaluation of subjects response to treatment [ Time Frame: 156 weeks ] [ Designated as safety To evaluate the efficacy of rfviiifc used in a surgical subgroup [ Time Frame: 156 weeks ] [ Designated as safety Target Sample Size Total Sample Size=150 Sample Size from =8 Phase of Trial Phase 2/ 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 29/09/ /11/2010 Years=2 Months=0 Days=0 Open to Recruitment Open to Recruitment The current hemophilia standard of care for the prevention of bleeds and arthropathy is to maintain FVIII activity level above 1%. Due to the short half-life of the current FVIII products, prophylaxis therapy will require injection of 2-3 times per week or every other day. Treatment usually involves intravenous access, an invasive procedure, especially difficult in children. Episodic treatment will involve 1-3 injections to treat bleeding episodes, depending on the severity of the hemorrhage. Severe hemophilia patients will treat prophylactically with the long-lasting recombinant factor VIII Fc fusion protein (rfviiifc) in an interval to maintain FVIII activity level above 1%. Any bleeding episodes will be reported. The response to treatment will also be recorded to access the effectiveness of the rfviiifc. page 5 / 5