A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials

Sponsor

Gilead Sciences (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02510300

Collaborator

(none)

461

Enrollment

Locations

85.4

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Registry will enroll adolescent and pediatric participants who received at least one Gilead Hepatitis C Virus (HCV) direct acting antiviral (DAA) while participating in a Gilead-sponsored chronic hepatitis C clinical trial. The primary objective of this Registry is to determine the long-term safety of anti-HCV regimens in the pediatric population. Secondary objectives of this Registry are to determine whether subsequent detection of HCV RNA in participants who relapse following sustained virologic response (SVR) represents the re-emergence of pre-existing virus, the development of resistance mutations, or whether it is due to re-infection, and to characterize resistance mutations and the persistence of resistance mutations in pediatric participants who did not achieve SVR. Once enrolled, participants will be followed for up to 5 years.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Virus Infection	Drug: Sofosbuvir (SOF) Drug: Ledipasvir/Sofosbuvir (LDV/SOF) Drug: Sofosbuvir/Velpatasvir (SOF/VEL) Drug: Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX)

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

461 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Long Term Follow-up Registry for Adolescent and Pediatric Subjects Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials

Actual Study Start Date :

Oct 21, 2015

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

Growth data as measured by body height [Up to 5 years]
Growth data as measured by body weight [Up to 5 years]
Development as measured by Tanner Pubertal Stage Assessment [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Have previously participated in a Gilead-sponsored chronic hepatitis C study as an adolescent or pediatric participant and received at least one Gilead HCV direct acting antiviral
Parent or legal guardian able to provide written informed consent OR individual is able to provide written informed consent prior to any study procedures and willing to comply with study requirements as determined by institutional review board (IRB)/independent ethics committee(IEC)/local requirements and Investigator's discretion.
Individual is able to provide written assent, if they have the ability to read and write, as determined by IRB/IEC/local requirements and Investigator's discretion

Key Exclusion Criteria:

Individual is currently receiving or plans to initiate a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry.
History of clinically-significant illness or any other major medical disorder that may interfere with the individual's 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	Phoenix Children's Hospital	Phoenix	Arizona	United States	85016
2	Children's Hospital Los Angeles, Div. of Research Immunology/BMT	Los Angeles	California	United States	90027
3	University of California San Francisco	San Francisco	California	United States	94158
4	Children's Hospital of Colorado	Aurora	Colorado	United States	80045
5	Children's National Medical Center	Washington	District of Columbia	United States	20010
6	University of Florida	Gainesville	Florida	United States	32610
7	AdventHealth Orlando	Orlando	Florida	United States	32803
8	Children's Healthcare of Atlanta at Egleston	Atlanta	Georgia	United States	30322
9	Riley Hospital for Children	Indianapolis	Indiana	United States	46202
10	University of Louisville School of Medicine	Louisville	Kentucky	United States	40202
11	Johns Hopkins University School of Medicine	Baltimore	Maryland	United States	21287
12	Boston Children's Hospital	Boston	Massachusetts	United States	02115
13	Children's Mercy Hospital and Clinics	Kansas City	Missouri	United States	64108
14	Saint Louis University School of Medicine	Saint Louis	Missouri	United States	63104
15	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
16	Mount Sinai Medical Center	New York	New York	United States	10029
17	UNC Pediatrics/NC Children's Hospital	Chapel Hill	North Carolina	United States	27599
18	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
19	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
20	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
21	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee	United States	37232
22	Children's Medical Center Dallas	Dallas	Texas	United States	75235
23	Cook Children's Health Care System	Fort Worth	Texas	United States	76104
24	Texas Children's Hospital	Houston	Texas	United States	77030
25	Texas Liver Institute	San Antonio	Texas	United States	78215
26	Seattle Children's Hospital	Seattle	Washington	United States	98105
27	West Virginia University Children's Hospital	Morgantown	West Virginia	United States	26506
28	John Hunter Children's Hospital (JHCH)	New Lambton Heights	New South Wales	Australia	2305
29	The Children's Hospital at Westmead	Westmead	New South Wales	Australia	2145
30	The Royal Children's Hospital	Parkville	Victoria	Australia	3052
31	Cliniques Universitaires Saint- LUC UCL	Brussels		Belgium	1200
32	Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum	Berlin		Germany	13353
33	Helios Klinikum Wuppertal	Wuppertal		Germany	42283
34	Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo	Foggia	Italy	71013
35	Policlinico Sant'Orsola Malpighi	Bologna		Italy	40138
36	Azienda Ospedaliero Universitaria - Ospedale Pediatrico Meyer	Firenze		Italy	50139
37	Polo Universitario - L'Azienda Ospedaliera Luigi Sacco	Milano		Italy	20157
38	Azienda Ospedaliera Universitaria Federico II	Napoli		Italy	80131
39	Azienda Ospedaliero-Universitaria di Padova	Padova		Italy	35128
40	Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino	Torino		Italy	10126
41	Auckland Clinical Studies	Auckland		New Zealand	1010
42	Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza, Klinika Chorób Zakaźnych i Hepatologii Wieku Rozwojowego	Bydgoszcz		Poland	85-030
43	MED. POLONIA Sp. z.o.o.	Poznan		Poland	60-693
44	Federal Budget Institution of Science-Central Scientific and Research Institute of Epidemiology	Moscow		Russian Federation	111123
45	Scientific-Research Institute of Children's Infections of Federal Medico- Biological Agency	Saint Petersburg		Russian Federation	197022
46	Federal Government Institution "Republican Clinical Infectious Hospital"	Saint-Petersburg		Russian Federation	196645
47	Ltd Medical Company "Hepatolog"	Tolyatti		Russian Federation	445009
48	Birmingham Childrens Hospital NHS Trust	Birmingham		United Kingdom	B4 6NH
49	Royal Hospital for Sick Children Glasgow	Glasgow		United Kingdom	G3 8SJ
50	Leeds Teaching Hospitals NHS Trust	Leeds		United Kingdom	LS9 7TF
51	King's College Hospital	London		United Kingdom	SE5 9RS