A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT02292706

Collaborator

(none)

1,609

Enrollment

138

Locations

84.1

Actual Duration (Months)

11.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Registry will enroll participants with cirrhosis with or without decompensated liver disease who have achieved a sustained virologic response (SVR) after receiving a sofosbuvir (SOF)-based regimen without interferon (IFN) while participating in a Gilead-sponsored hepatitis C virus (HCV) study or commercially at selected sites. Once enrolled, participants will be followed for up to 5 years.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Virus Infection	Drug: Sofosbuvir

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1609 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

Actual Study Start Date :

Dec 29, 2014

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

Proportion of participants maintaining sustained virologic response (SVR) at Week 240 [Week 240]
Proportion of participants who develop liver disease progression or regression, as assessed by clinical and laboratory parameters [Up to 240 weeks]
Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 240 [Up to 240 weeks]

Secondary Outcome Measures

Proportion of participants with detectable HCV RNA due to re-emergence of pre-existing virus through Week 240 [Up to 240 weeks]
Proportion of participants with detectable HCV resistance mutations through Week 240 [Up to 240 weeks]
Proportion of participants with detectable HCV RNA due to re-infection through Week 240 [Up to 240 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Willing and able to provide written informed consent
Have either previously participated in a Gilead-sponsored HCV study and received a sofosbuvir-containing regimen without interferon OR at pre-selected sites only, have received an all-oral SOF-based regimen outside a clinical study. These individuals must have documentation of the regimen, start and end of treatment dates (month and year), and of having achieved SVR12.
Have achieved SVR either in a Gilead-sponsored study, as defined in the treatment protocol OR for individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, SVR will be defined as HCV RNA < LLOQ approximately 12 weeks following last dose of treatment.
Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver transplant after receiving a SOF-containing regimen OR individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, will have had cirrhosis confirmed prior to initiation of HCV treatment.

Key Exclusion Criteria:

Individuals planning to initiate a new course of HCV therapy, including approved products and any investigational agents, during the course of this Registry
History of clinically-significant illness or any other major medical disorder that may interfere with the follow-up, assessments, or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States
2	Scripps Clinic Medical Group	La Jolla	California	United States
3	V.A. Long Beach Medical Center	Long Beach	California	United States
4	Cedars Sinai Medical Center	Los Angeles	California	United States
5	Kaiser Permanente Medical Center	Los Angeles	California	United States
6	Tarrant County ID Associates	Los Angeles	California	United States
7	The Liver Center	Pasadena	California	United States
8	Inland Empire Liver Foundation	Rialto	California	United States
9	University of California, Davis Medical Center	Sacramento	California	United States
10	Kaiser Permanente	San Diego	California	United States
11	Medical Associates Research Group	San Diego	California	United States
12	Quest Clinical Research	San Francisco	California	United States
13	University of California at San Francisco Medical Center	San Francisco	California	United States
14	Stanford University	Stanford	California	United States
15	University of Colorado	Aurora	Colorado	United States
16	Georgetown University Medical Center	Washington	District of Columbia	United States
17	Whitman-Walker Health	Washington	District of Columbia	United States
18	UF Hepatology Research at CTRB	Gainesville	Florida	United States
19	Borland-Groover Clinic	Jacksonville	Florida	United States
20	University of Miami Miller School of Medicine	Miami	Florida	United States
21	Orlando Immunology Center	Orlando	Florida	United States
22	Tampa General Hospital	Tampa	Florida	United States
23	South Florida Center of Gastroenterology	Wellington	Florida	United States
24	Atlanta Gastroenterology Associates	Atlanta	Georgia	United States
25	Atlanta Medical Center	Atlanta	Georgia	United States
26	Emory University Hospital Midtown	Atlanta	Georgia	United States
27	Gastrointestinal Specialists of Georgia, PC	Marietta	Georgia	United States
28	Northwestern University	Chicago	Illinois	United States
29	Indiana University	Indianapolis	Indiana	United States
30	Indianapolis Gastroenterology Research Foundation	Indianapolis	Indiana	United States
31	University of Kansas Medical Center Research Institute, Inc.	Kansas City	Kansas	United States
32	Delta Research Partners	Monroe	Louisiana	United States
33	Ochsner Clinic Foundation	New Orleans	Louisiana	United States
34	Mercy Medical Center	Baltimore	Maryland	United States
35	Digestive Disease Associates, PA	Catonsville	Maryland	United States
36	Johns Hopkins Hospital/University	Lutherville	Maryland	United States
37	Community Research Initiative of New England	Boston	Massachusetts	United States	02129
38	BIDMC Liver Center	Boston	Massachusetts	United States	02215
39	University of Michigan Medical Center	Ann Arbor	Michigan	United States
40	Henry Ford Health System	Detroit	Michigan	United States
41	University of Minnesota Medical Center	Minneapolis	Minnesota	United States
42	Mayo Clinic	Rochester	Minnesota	United States
43	Minnesota Gastroenterology, PA	Saint Paul	Minnesota	United States
44	Kansas City Research Institute, LLC	Kansas City	Missouri	United States
45	Saint Louis University	Saint Louis	Missouri	United States
46	ID Care, Inc	Hillsborough	New Jersey	United States	08844
47	Southwest CARE Center	Santa Fe	New Mexico	United States
48	Binghamton Gastroenterology Associates, PC	Binghamton	New York	United States
49	North Shore Health Inc.	Manhasset	New York	United States
50	Columbia University Medical Center	New York	New York	United States
51	Icahn School of Medicine at Mount Sinai	New York	New York	United States
52	New York University Medical Center	New York	New York	United States
53	Weill Cornell Medical College	New York	New York	United States
54	Asheville Gastroenterology Associates, PA	Asheville	North Carolina	United States
55	Carolinas Medical Center	Charlotte	North Carolina	United States
56	Duke University Medical Center	Durham	North Carolina	United States
57	Cumberland Research Associates, LLC	Fayetteville	North Carolina	United States
58	Cleveland Clinic Foundation	Cleveland	Ohio	United States
59	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States
60	University of Pennsylvania Health System	Philadelphia	Pennsylvania	United States
61	University of Pittsburgh Medical Center	Philadelphia	Pennsylvania	United States
62	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States
63	University Gastroenterology	Providence	Rhode Island	United States	02905
64	Gastroenterology Center of the MidSouth, P.C.	Germantown	Tennessee	United States
65	Nashville Gastrointestinal Specialists, Inc.	Nashville	Tennessee	United States
66	Vanderbilt University Medical Center	Nashville	Tennessee	United States
67	The North Texas Clinical Research Institute	Arlington	Texas	United States
68	Baylor Endocrine Center	Dallas	Texas	United States
69	North Texas Research Institute	Dallas	Texas	United States
70	St. Luke's Episcopal Hospital	Houston	Texas	United States
71	The Texas Liver Institute	San Antonio	Texas	United States
72	Intermountain Medical Center	Murray	Utah	United States
73	INOVA Fairfax Hospital	Annandale	Virginia	United States
74	Bon Secours St. Mary's Hospital of Richmond	Newport News	Virginia	United States
75	Digestive and Liver Disease Specialists	Norfolk	Virginia	United States
76	Harborview Medical Center	Seattle	Washington	United States
77	Virginia Mason Medical Center	Seattle	Washington	United States
78	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia
79	Kirby Institute	Sydney	New South Wales	Australia
80	Westmead Hospital	Westmead	New South Wales	Australia
81	Royal Brisbane & Women's Hospital	Herston	Queensland	Australia
82	Princess Alexandra Hospital	Woolloongabba	Queensland	Australia
83	St Vincents Hospital Sydney	Fitzroy	Victoria	Australia
84	Austin Health	Heidelberg	Victoria	Australia	3084
85	Monash Medical Centre Clayton Campus	Melbourne	Victoria	Australia
86	The Alfred Hospital	Prahran	Victoria	Australia
87	Fiona Stanley Hospital	Fremantle	Western Australia	Australia
88	Royal Perth Hospital	Perth	Western Australia	Australia
89	University of Calgary	Calgary	Alberta	Canada
90	GI Research Institute	Vancouver	British Columbia	Canada
91	Vancouver Infectious Disease Research and Care Centre	Vancouver	British Columbia	Canada
92	London Health Sciences Centre - University Campus	London	Ontario	Canada
93	University Health Network	Toronto	Ontario	Canada
94	CRCHUM	Montréal	Quebec	Canada
95	University of Alberta	Edmonton		Canada	T6G 2B7
96	Hôpital Pontchaillou	Rennes	Bretagne	France
97	Hopital de La Pitié-Salpêtrière	Paris	Ile De France	France
98	CHU Montpellier - Hopital St. Eloi	Montpellier Cedex 05	Languedoc-Rousillon	France
99	Hôpital Universitaire Dupuytren	Limoges Cedex	Limousin	France
100	Hopital Purpan	Toulouse	Midi-Pyrenees	France
101	Hopital Saint Joseph	Marseille Cedex 08	Provence Alpes Cote D'Azur	France
102	Groupe Hospitalier Archet I Et II	Nice Cedex 3	Provence Alpes Cote D'Azu	France	06202
103	Hopital Haut Leveque	Bordeaux		France
104	CHU Estaing	Clermont Ferrand		France
105	Hôpital Beaujon	Clichy		France
106	Hopital Henri Mondor	Creteil Cedex		France
107	CHU de Grenoble- Hopital Michallon	Grenoble Cedex 9		France
108	Hopital Cochin	Paris, Cedex 14		France
109	Hopital Tenon	Paris		France
110	Hôpital de la Croix Rousse	Paris		France
111	Hôpitaux Universitaires de Strasbourg	Strasbourg		France
112	CHU de Nancy-Hopital Brabois Adulte	Vandoeuvre les Nancy		France
113	Hôpital Paul Brousse	Villejuif		France
114	Klinikum der Johann Wolfgang Goethe Universitat	Frankfurt am Main		Germany
115	Universitätsklinikum Hamburg-Eppendorf	Hamburg		Germany	20251
116	Asklepios Klinik St. Georg	Hamburg		Germany
117	Universitatsklinikum Koln	Koln		Germany
118	Technische Universität München	Mücheln		Germany
119	Azienda Ospedaliera Ospedale Niguarda Cà Granda	Milano		Italy
120	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano		Italy
121	Ospedale Casa Sollievo Della Sofferenza IRCCS	San Giovanni Rotondo		Italy
122	Azienda Ospedaliera Città della Salute e della Scienza di Torino	Torino		Italy
123	Auckland Clinical Studies Ltd	Auckland	North Island	New Zealand
124	Waikato Hospital	Hamilton	North Island	New Zealand
125	Christchurch Hospital	Christchurch	South Island	New Zealand
126	Fundacion de Investigation de Diego	San Juan		Puerto Rico	00927
127	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid	Spain
128	Hospital Clinic de Barcelona	Barcelona		Spain	08028
129	Hospital Universitario Vall d'Hebron	Barcelona		Spain	08035
130	Hospital Virgen de Valme	Sevilla		Spain
131	Hospital Universitari i Politecnic La Fe de Valencia	Valencia		Spain
132	Barts Health NHS Trust	London	England	United Kingdom
133	Kings College Hospital	London	England	United Kingdom
134	St Georges University of London	London	England	United Kingdom
135	North Manchester General Hospital	Manchester	England	United Kingdom
136	Nottingham University Hospitals NHS Trust	Nottingham	England	United Kingdom
137	Gartnavel General Hospital	Glasgow	Scotland	United Kingdom
138	Queen Alexandra Hospital	Portsmouth		United Kingdom