A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects
a study on Hepatitis C
The purpose of this three part study is to evaluate the pharmacokinetics (Part 1), safety/efficacy (Part 2), and long-term follow-up (Part 3) of ombitasvir (OBV), paritaprevir (PTV), ritonavir (RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in pediatric subjects with genotype 1 or 4 chronic hepatitis C virus (HCV) infection.
An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Ombitasvir (OBV), Paritaprevir (PTV), Ritonavir (RTV) With or Without Dasabuvir (DSV) and With or Without Ribavirin (RBV) in Pediatric Subjects With Genotype 1 or 4 Chronic Hepatitis C Virus (HCV) Infection (ZIRCON)
Chronic Hepatitis C Infection Hepatitis C Genotype 4 Pediatric Hepatitis C Genotype 1 Hepatitis C Virus Ribavirin Ritonavir
You can join if…
Open to people ages 3–17
- Positive anti-HCV Ab and HCV RNA greater than or equal to 1000 IU/mL at the time of screening.
- HCV genotype 1 for enrollment into Part 1 and genotype 1 or 4 for enrollment into Part 2.
- Parent or legal guardian with the willingness and ability to provide written informed consent and participant willing and able to give assent, as appropriate for age and country.
You CAN'T join if...
- Women who are pregnant, breastfeeding or are considering becoming pregnant
- Use of known strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8(CYP2C8) in participants receiving dasabuvir, or strong or moderate inducers of CYP3A,within 2 weeks or 10 half lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
- Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibody (HIV Ab) test.
- Current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-HCV agents other than IFNs or RBV or receipt of any investigational product within 6 weeks prior to study drug administration.
- University of California, San Francisco /ID# 136774 accepting new patients
San Francisco, California, 94143, United States
- Seattle Children's Hospital /ID# 137019 in progress, not accepting new patients
Seattle, Washington, 98105, United States
- Children's Hospital Colorado /ID# 137017 accepting new patients
Aurora, Colorado, 80045-7106, United States
- University of Alberta /ID# 141206 withdrawn
Edmonton, T6G 1C9, Canada
- Louisiana Research Center, LLC /ID# 136775 withdrawn
Shreveport, Louisiana, 71061, United States
- Texas Children's Hospital /ID# 136590 accepting new patients
Houston, Texas, 77030, United States
- Riley Hospital for Children /ID# 137015 accepting new patients
Indianapolis, Indiana, 46202, United States
- Cincinnati Children's Hospital Medical Center /ID# 136408 withdrawn
Cincinnati, Ohio, 45229, United States
- University of Florida /ID# 136830 accepting new patients
Gainesville, Florida, 32610, United States
- University of North Carolina at Chapel Hill /ID# 136589 not yet accepting patients
Chapel Hill, North Carolina, 27599-7596, United States
- The Children's Hospital of Philadelphia (CHOP) /ID# 137018 accepting new patients
Philadelphia, Pennsylvania, 19104, United States
- Columbia University Medical Center /ID# 136431 accepting new patients
New York, New York, United States
- Boston Childrens Hospital /ID# 137174 accepting new patients
Boston, Massachusetts, 02115, United States
- Boston Medical Center /ID# 136831 accepting new patients
Boston, Massachusetts, 02118, United States
- San Jorge Children Hospital /ID# 136832 in progress, not accepting new patients
San Juan, 00912, Puerto Rico
- King's College Hospital /ID# 139405 withdrawn
London, SE5 9RS, United Kingdom
- Cliniques Universitaires Saint Luc /ID# 136910 in progress, not accepting new patients
Brussels, 1200, Belgium
- Universitair Ziekenhuis Leuven, Campus Gasthuisberg /ID# 136911 in progress, not accepting new patients
Leuven, 3000, Belgium
- Charite Universitatesmedizin Berlin, CCM /ID# 141620 in progress, not accepting new patients
Berlin, 13353, Germany
- Universitaetsklinikum Freiburg /ID# 141618 in progress, not accepting new patients
Freiburg, 79106, Germany
- Helios Klinikum Wuppertal /ID# 142883 in progress, not accepting new patients
Wuppertal, 42283, Germany
- Hospital Sant Joan de Deu, Althaia /ID# 137096 in progress, not accepting new patients
Barcelona, 08950, Spain
- Hospital Universitario Vall d'Hebron /ID# 137098 in progress, not accepting new patients
Barcelona, 8035, Spain
- Hospital Universitario La Paz /ID# 137094 in progress, not accepting new patients
Madrid, 28046, Spain
- Hospital Universitario y Politecnico La Fe /ID# 137097 in progress, not accepting new patients
Valencia, 46026, Spain
- Inselspital - Universitaetsspital Bern /ID# 141825 withdrawn
Bern, 3010, Switzerland
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02486406.