NCT02486406

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

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)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study population for Part 1, the PK study, included GT1-infected participants who were noncirrhotic and treatment-naïve (TN). Part 2, the safety and efficacy study, included GT1 or GT4-infected participants who were TN or interferon (\[IFN\] or Pegylated-interferon alfa-2a or 2b \[pegIFN\] with or without RBV) treatment-experienced (TE) without cirrhosis or with compensated cirrhosis. In Part 1 and Part 2, the treatment regimen and duration were dependent on HCV GT, GT1 subtype, and cirrhosis status.

Conditions

• Chronic Hepatitis C Infection

Interventions

Type	Name	Description
DRUG	Ombitasvir/paritaprevir/ritonavir	Film-coated tablet for oral use
DRUG	Dasabuvir	Film-coated tablet for oral use
DRUG	Ribavirin	Film-coated tablet for oral use
DRUG	Ombitasvir mini tablet	Film-coated tablet for oral use
DRUG	Paritaprevir mini tablet	Film-coated tablet for oral use
DRUG	Ritonavir mini tablet	Film-coated tablet for oral use
DRUG	Dasabuvir mini tablet	Film-coated tablet for oral use
DRUG	Ribavirin solution	Oral solution

Timeline

• Start date: 2015-10-28
• Primary completion: 2020-11-19
• Completion: 2020-11-19
• First posted: 2015-07-01
• Last updated: 2021-10-05
• Results posted: 2021-10-05

Locations

21 sites across 5 countries: United States, Belgium, Germany, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study