CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 64 enrolled
Drug / intervention
Ombitasvir/paritaprevir/ritonavir +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02486406
NCT02486406Phase 3Completed

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)

AbbVie·interventional·Posted Jul 1, 2015·Updated Oct 5, 2021

In Brief

A Phase 3 clinical trial evaluating Ombitasvir/paritaprevir/ritonavir, Dasabuvir, and 6 other interventions for Chronic Hepatitis C Infection. Completed, enrolled 64 participants across 21 sites in 5 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Germany, Puerto Rico, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 1, 2015
Enrollment StartOct 28, 2015
Primary CompletionNov 19, 2020
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 11.0 years ago

Interventions

Ombitasvir/paritaprevir/ritonavirdrug

Film-coated tablet for oral use

Dasabuvirdrug

Film-coated tablet for oral use

Ribavirindrug

Film-coated tablet for oral use

Ombitasvir mini tabletdrug

Film-coated tablet for oral use

Paritaprevir mini tabletdrug

Film-coated tablet for oral use

Ritonavir mini tabletdrug

Film-coated tablet for oral use

Dasabuvir mini tabletdrug

Film-coated tablet for oral use

Ribavirin solutiondrug

Oral solution