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Eligibility
for people ages 3 years to 17 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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.

Official Title

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)

Keywords

Chronic Hepatitis C Infection Hepatitis C Genotype 4 Pediatric Hepatitis C Genotype 1 Hepatitis C Virus Ribavirin Ritonavir

Eligibility

You can join if…

Open to people ages 3 years to 17 years

  1. Positive anti-HCV Ab and HCV RNA greater than or equal to 1000 IU/mL at the time of screening.
  2. HCV genotype 1 for enrollment into Part 1 and genotype 1 or 4 for enrollment into Part 2.
  3. 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...

  1. Women who are pregnant, breastfeeding or are considering becoming pregnant
  2. 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.
  3. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibody(HIV Ab) test.
  4. 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.

Locations

  • Children's Hospital Colorado /ID# 137017 accepting new patients
    Aurora, Colorado, 80045, USA
  • University of Florida /ID# 136830 accepting new patients
    Gainesville, Florida, 32610, USA
  • Riley Hospital for Children /ID# 137015 accepting new patients
    Indianapolis, Indiana, 46202, USA
  • Louisiana Research Center, LLC /ID# 136775 withdrawn
    Shreveport, Louisiana, 71061, USA
  • Boston Childrens Hospital /ID# 137174 accepting new patients
    Boston, Massachusetts, 02115, USA
  • Boston Medical Center /ID# 136831 accepting new patients
    Boston, Massachusetts, 02118, USA
  • Columbia University Medical Center /ID# 136431 accepting new patients
    New York, New York, USA
  • University of North Carolina at Chapel Hill /ID# 136589 not yet accepting patients
    Chapel Hill, North Carolina, 27599, USA
  • Cincinnati Children's Hospital Medical Center /ID# 136408 withdrawn
    Cincinnati, Ohio, 45229, USA
  • The Children's Hospital of Philadelphia (CHOP) /ID# 137018 accepting new patients
    Philadelphia, Pennsylvania, 19104, USA
  • Texas Children's Hospital /ID# 136590 accepting new patients
    Houston, Texas, 77030, USA
  • Seattle Children's Hospital /ID# 137019 in progress, not accepting new patients
    Seattle, Washington, 98105, USA
  • 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
  • University of Alberta /ID# 141206 withdrawn
    Edmonton, T6G 1C9, Canada
  • 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
  • San Jorge Children Hospital /ID# 136832 in progress, not accepting new patients
    San Juan, 00912, Puerto Rico
  • 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
  • King's College Hospital /ID# 139405 withdrawn
    London, SE5 9RS, United Kingdom

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02486406
Phase
Phase 3
Lead Scientist
Philip Rosenthal
Study Type
Interventional
Last Updated
April 2017
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