The Chair opened the meeting at 12:00pm and welcomed Committee members, noting that apologies had been received from Mrs Stephanie Pollard. The Chair noted that fewer than five appointed members of the Committee were present, and that it would be necessary to co-opt members of other HDECs in accordance with the SOPs. Ms Shamim Chagani confirmed their eligibility, and were co-opted by the Chair as members of the Committee for the duration of the meeting. The noted that the meeting was quorate. The Committee noted and agreed the agenda for the meeting. Confirmation of previous minutes The minutes of the meeting of 06 October 2015 were confirmed. New applications 1 Ethics ref: 15/NTB/209 Title: HCV in Renally-Impaired Adults (EXPEDITION-4) Principal Investigator: Prof Edward Gane Sponsor: AbbVie Clock Start Date: 22 October 2015 Prof. Ed Gane and Ms Angelle Lockie were present by teleconference for discussion of this application. Potential conflicts of interest The Chair asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of Study This study will consider a new treatment regime for patients with Hepatitis C and renal failure. The current treatments are unsuitable for these patients as they cause severe anemia and patients with renal failure will already have anemia. The new treatment regime involves a combination of two drugs. This combination has been tested in participants with normal renal function and it has shown good tolerability, this study aims to test this treatment in patients with renal failure. The Committee noted that this is an interesting study and that the application was well written and easy to understand. Summary of ethical issues (resolved)
The Chair opened the meeting at 12:00pm and welcomed Committee members, noting that apologies had been received from Mrs Stephanie Pollard. The Chair noted that fewer than five appointed members of the Committee were present, and that it would be necessary to co-opt members of other HDECs in accordance with the SOPs. Ms Shamim Chagani confirmed their eligibility, and were co-opted by the Chair as members of the Committee for the duration of the meeting. The noted that the meeting was quorate. The Committee noted and agreed the agenda for the meeting. Confirmation of previous minutes The minutes of the meeting of 06 October 2015 were confirmed. New applications 1 Ethics ref: 15/NTB/209 Title: HCV in Renally-Impaired Adults (EXPEDITION-4) Principal Investigator: Prof Edward Gane Sponsor: AbbVie Clock Start Date: 22 October 2015 Prof. Ed Gane and Ms Angelle Lockie were present by teleconference for discussion of this application. Potential conflicts of interest The Chair asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of Study This study will consider a new treatment regime for patients with Hepatitis C and renal failure. The current treatments are unsuitable for these patients as they cause severe anemia and patients with renal failure will already have anemia. The new treatment regime involves a combination of two drugs. This combination has been tested in participants with normal renal function and it has shown good tolerability, this study aims to test this treatment in patients with renal failure. The Committee noted that this is an interesting study and that the application was well written and easy to understand. Summary of ethical issues (resolved)
ntb-3-november-2015-meeting-minutes.docx