drugset / Trial / NCT02461745

Real World Study: Genotype 1 Chronic Hepatitis C Virus Treatment and Evaluation of Real World SVR and PRO

NCT02461745

Phase 4 Completed 200 enrolled Kaiser Permanente AbbVie · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase IV, open-label, multi-center study to evaluate the real world sustained virological response rate, subject adherence, and subject reported outcomes during and after treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older, with VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir), with or without RBV (ribavirin).

Timeline

Start
2015-06
Primary completion
2017-05
Completion
2017-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ribavirin Small molecule
Comparator Ritonavir Other / unclassified 50 mg
Comparator dasabuvir Small molecule 250 mg
Comparator ombitasvir Small molecule 12.5 mg
Comparator paritaprevir Small molecule 75 mg