NCT02493855

Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults

An Exploratory Study to Evaluate the Kinetics of Viral Load Decline With Ombitasvir/ABT 450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV) ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in treatment-naive HCV genotype (GT) 1a-infected adults.

Conditions

• Chronic Hepatitis C
• Hepatitis C (HCV)
• Hepatitis C Genotype 1a

Interventions

Type	Name	Description
DRUG	Ombitasvir/ABT-450/Ritonavir	Ombitasvir/ABT-450/ritonavir combination tablets
DRUG	Dasabuvir	Dasabuvir tablets
DRUG	Ribavirin (RBV)	Ribavirin tablets

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-04-01
• Completion: 2016-12-01
• First posted: 2015-07-10
• Last updated: 2017-10-31
• Results posted: 2017-05-15