A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects

Completed · Phase 2/Phase 3

Conditions studied: Chronic Hepatitis C Infection

In brief

This was a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics (PK), efficacy, and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in Hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4)-infected pediatric participants of ≥ 3 to 17 years of age.

Key facts

Study ID

NCT02486406

Run by

AbbVie

People needed

64

Starts

2015-10-28

Expected to finish

2020-11-19

Last updated by the study team

2021-10-05

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Positive anti-hepatitis C virus antibody (HCV Ab) and HCV ribonucleic acid (RNA) ≥ 1000 IU/mL at the time of screening
• HCV genotype 1 for enrollment into Part 1 of the study 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 may not qualify if…

• Female participant who is pregnant, breastfeeding or is 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-human immunodeficiency virus 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 interferons or ribavirin or receipt of any investigational product within 6 weeks prior to study drug administration

Where it is running

• UCSF Benioff Childrens Hosp /ID# 136774 — San Francisco, California, United States
• Children's Hospital Colorado /ID# 137017 — Aurora, Colorado, United States
• University of Florida - Archer /ID# 136830 — Gainesville, Florida, United States
• Advent Health /ID# 167663 — Orlando, Florida, United States
• Indiana University /ID# 137015 — Indianapolis, Indiana, United States
• Boston Childrens Hospital /ID# 137174 — Boston, Massachusetts, United States
• Boston Medical Center /ID# 136831 — Boston, Massachusetts, United States
• Columbia Univ Medical Center /ID# 136431 — New York, New York, United States
• Children's Hospital of Philadelphia /ID# 137018 — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine /ID# 136590 — Houston, Texas, United States
• Seattle Children's Hospital /ID# 137019 — Seattle, Washington, United States
• Cliniques Universitaires Saint-Luc /ID# 136910 — Brussels, Brussels Capital, Belgium
• UZ Leuven /ID# 136911 — Leuven, Belgium
• Charite Universitaetsmedizin Berlin /ID# 141620 — Berlin, Germany
• Universitaetsklinikum Freiburg /ID# 141618 — Freiburg im Breisgau, Germany
• Helios Klinikum Wuppertal /ID# 142883 — Wuppertal, Germany
• San Jorge Children Hospital /ID# 136832 — San Juan, Puerto Rico
• Hospital Sant Joan de Deu /ID# 137096 — Esplugues de Llobregat, Barcelona, Spain
• Hospital Universitario Vall d'Hebron /ID# 137098 — Barcelona, Spain
• Hospital Universitario La Paz /ID# 137094 — Madrid, Spain
• Hospital Universitario y Politecnico La Fe /ID# 137097 — Valencia, Spain

Full record on ClinicalTrials.gov

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