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Observation Study of Persons with Chronic Hepatitis B Virus infection in North America

Award Number: U01DK082874
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary BACKGROUND The Hepatitis B Research Network (HBRN) was created in 2008 to address several research challenges regarding chronic hepatitis B (CHB). The HBRN was charged with establishing a large cohort of patients with hepatitis B virus (HBV) infection to study the natural history of HBV infection and designing treatment protocols(s) to compare monotherapy to combination therapy using clinical outcomes as endpoints. There are 12 consortia (22 clinical sites) recruiting adult and pediatric patients including the Toronto site (University Health Network, Toronto General Hospital & Hospital for Sick Children) to address the following specific aims: Specific Aims: 1. To describe participants with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression 2. To define the role of limited duration peginterferon alfa-2a in the presence of tenofovir for treating people with chronic hepatitis B (Immune Active (IA) Trial) 3. To evaluate “off treatment” safety and sustained responses after treatment with entecavir and peginterferon alfa-2a in the treatment of chronic hepatitis B in HBeAg positive adults who are in the immune tolerant phase. (Immune Tolerant (IT) Trial) 4. The clinical and virological status of chronic HBV infection is defined by distinct patterns of immune effector and regulatory responses. 5. To examine if therapeutic HBV suppression will enhance antiviral immune effector responses and reduce immune inhibitory factors in participants with chronic hepatitis B With the highest number of enrolled patients and among the best retention rates in all categories of HBRN studies, Toronto is the leading site among the HBRN consortium. As of October 31st 2016, Toronto clinics have enrolled 437 patients including 300 adult and 137 pediatrics patients in the cohort study from a total number of 2427 (18%) enrolled patients across the network. Toronto also is the leading enrolling site in the two main treatment trials of the HBRN, the Adult Immune Active (IA) study and the pediatric/adult Immune Tolerant (IT) study. Toronto investigators are actively involved in numerous ancillary studies, including the ongoing immunology studies as well as studies on virological and clinical outcomes. Toronto investigators also participate actively on numerous committees throughout the network. Overall, in addition to retaining and recruiting patients, Toronto site has played an important role in the HBRN and will continue to be actively involved in all aspects of the network to ensure its continued success.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$144,336 )
2025	2019	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON			CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	11	10/1/2024	NON-COMPETING CONTINUATION	-$144,336
														Subtotal = -$144,336

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2019	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON			CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	11	11/23/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2019	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON			CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	11	11/1/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON			CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	11	6/30/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $335,752 )
2019	2019	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON	M5G 2C4		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	11	6/6/2019	NON-COMPETING CONTINUATION	$335,752
														Subtotal = $335,752

Issue Date FY: 2018 ( Subtotal = $577,003 )
2018	2018	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON	M5G 2C4		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	10	7/16/2018	NON-COMPETING CONTINUATION	$577,003
2018	2017	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON	M5G 2C4		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	9	3/31/2018	COMPETING CONTINUATION	$510,905
2018	2017	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON	M5G 2C4		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	8	3/31/2018	SUPPLEMENT FOR EXPANSION	-$29,759
2018	2016	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON	M5G 2C4		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	3/31/2018	SUPPLEMENT FOR EXPANSION	-$481,146
														Subtotal = $577,003

Issue Date FY: 2017 ( Subtotal = $943,730 )
2017	2017	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON	M5G 2C4		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	3/29/2017	SUPPLEMENT FOR EXPANSION	$29,759
2017	2017	UNIVERSITY HEALTH NETWORK	200 ELIZABETH ST	TORONTO	ON	M5G 2C4		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	9	8/4/2017	COMPETING CONTINUATION	$913,971
														Subtotal = $943,730

Issue Date FY: 2016 ( Subtotal = $889,332 )
2016	2016	UNIVERSITY HEALTH NETWORK	200 ELIZABETH STREET	TORONTO ONTARIO				CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	7/29/2016	SUPPLEMENT FOR EXPANSION	$889,332
														Subtotal = $889,332

Issue Date FY: 2015 ( Subtotal = $589,571 )
2015	2015	UNIVERSITY HEALTH NETWORK	200 ELIZABETH STREET	TORONTO ONTARIO				CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	8/24/2015	COMPETING CONTINUATION	$589,571
2015	2014	UNIVERSITY HEALTH NETWORK	200 ELIZABETH STREET 8N-842	TORONTO, ONTARIO CANDA					Diabetes, Digestive, and Kidney Diseases Extramural Research	001	7	8/24/2015	NON-COMPETING CONTINUATION	$0
														Subtotal = $589,571

Issue Date FY: 2014 ( Subtotal = $893,765 )
2014	2014	UNIVERSITY HEALTH NETWORK	190 Elizabeth Street	TORONTO				CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	7	8/28/2014	NON-COMPETING CONTINUATION	$893,765
														Subtotal = $893,765

Issue Date FY: 2013 ( Subtotal = $875,047 )
2013	2013	UNIVERSITY HEALTH NETWORK	190 Elizabeth Street	TORONTO				CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	6	8/26/2013	EXTENSION WITH OR WITHOUT FUNDS	$875,047
2013	2012	TORONTO WESTERN HOSPITAL	399 BAGHURST STREET	TORONTO, ONTARIO		00000		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	2/25/2013	NON-COMPETING CONTINUATION	$0
														Subtotal = $875,047

Issue Date FY: 2012 ( Subtotal = $497,444 )
2012	2012	TORONTO WESTERN HOSPITAL	190 Elizabeth St	TORONTO				CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	9/14/2012	NON-COMPETING CONTINUATION	$497,444
														Subtotal = $497,444

Issue Date FY: 2011 ( Subtotal = $673,703 )
2011	2011	TORONTO WESTERN HOSPITAL	190 Elizabeth St	TORONTO				CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	9/8/2011	NON-COMPETING CONTINUATION	$573,703
2011	2010	TORONTO WESTERN HOSPITAL	190 Elizabeth St	TORONTO				CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	3/4/2011	NON-COMPETING CONTINUATION	$100,000
														Subtotal = $673,703

Issue Date FY: 2010 ( Subtotal = $257,304 )
2010	2010	UNIVERSITY HEALTH NETWORK	190 Elizabeth St	TORONTO				CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	9/7/2010	NON-COMPETING CONTINUATION	$257,304
														Subtotal = $257,304

Issue Date FY: 2009 ( Subtotal = $269,827 )
2009	2009	UNIVERSITY HEALTH NETWORK	190 Elizabeth St	TORONTO				CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	9/14/2009	NON-COMPETING CONTINUATION	$269,827
2009	2008	TORONTO WESTERN HOSPITAL	399 BAGHURST STREET	TORONTO, ONTARIO				CAN	Digestive Diseases and Nutrition Research	000	1	2/13/2009	NEW	$0
														Subtotal = $269,827

Grand Total All Awards = $6,658,142

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Observation Study of Persons with Chronic Hepatitis B Virus infection in North America

Award Number: U01DK082874

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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