Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults

Chronic Hepatitis C Virus (HCV Infection Genotype 1) Clinical Trial

Official title: An Open-Label, Treatment Duration-Ranging Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/ Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Treatment-Naive Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Status Completed

Clinical Trial Summary

This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C Virus (HCV Infection Genotype 1)
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

• NCT number: NCT02399345
• Study type: Interventional
• Source: AbbVie
• Status: Completed
• Phase: Phase 3
• Start date: March 2015
• Completion date: November 2015