Summary

for people ages 3–17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

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 Virus Hepatitis C Genotype 1 Hepatitis C Genotype 4 Pediatric Infection Communicable Diseases Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Ribavirin Ritonavir

Eligibility

You can join if…

Open to people ages 3–17

  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
  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

  • Univ California, San Francisco
    San Francisco, California, 94143-2204, United States
  • Seattle Children's Hospital
    Seattle, Washington, 98105, United States
  • Univ of Colorado Cancer Center
    Aurora, Colorado, 80045, United States
  • Baylor College of Medicine
    Houston, Texas, 77030-2608, United States
  • Indiana University
    Indianapolis, Indiana, 46202, United States
  • University of Florida
    Gainesville, Florida, 32610, United States
  • Florida Hospital
    Orlando, Florida, 32803, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania, 19104-5502, United States
  • Columbia Univ Medical Center
    New York, New York, 10032-3725, United States
  • Boston Childrens Hospital
    Boston, Massachusetts, 02115, United States
  • San Jorge Children Hospital
    San Juan, 00912-3310, Puerto Rico
  • Cliniques Universitaires Saint Luc
    Woluwe-Saint-Lambert, Bruxelles-Capitale, 1200, Belgium
  • UZ Leuven
    Leuven, 3000, Belgium
  • Charité Universitätsmedizin Campus Mitte
    Berlin, 10117, Germany
  • Universitätsklinikum Freiburg
    Freiburg, 79106, Germany
  • Helios Klinikum Wuppertal
    Wuppertal, 42283, Germany
  • Hospital Univ Vall d'Hebron
    Barcelona, 08035, Spain
  • Hospital Sant Joan de Deu
    Esplugues de Llobregat, 08950, Spain
  • Hospital Universitario La Paz
    Madrid, 28046, Spain
  • Hospital Universitario La Fe
    Valencia, 46026, Spain

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02486406
Phase
Phase 2
Lead Scientist
Philip Rosenthal
Study Type
Interventional
Last Updated
April 25, 2018