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

NCT02486406 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-10-05

Study results available
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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.

Conditions

  • Chronic Hepatitis C Infection

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-28
Primary Completion
2020-11-19
Completion
2020-11-19
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Puerto Rico
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02486406 on ClinicalTrials.gov