Summary

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

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 paritaprevir ombitasvir dasabuvir

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 /ID# 136774
    San Francisco California 94143-2204 United States
  • Seattle Children's Hospital /ID# 137019
    Seattle Washington 98105 United States

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