drugset / Trial / NCT02504099

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma

NCT02504099 ↗

Phase 3 Terminated 3 enrolled AbbVie
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or genotype 4 chronic HCV infection and treated early stage Hepatocellular Carcinoma with compensated cirrhosis.

Timeline

Start
2015-07
Primary completion
2016-09
Completion
2016-12

Outcome

Outcome not reported

Stopped (Enrollment): “Study stopped due to low enrollment”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ribavirin Small molecule 1000 mg —
Subject Ribavirin Small molecule 1200 mg —
Subject Ritonavir Other / unclassified 100 mg —
Subject dasabuvir Small molecule 250 mg —
Subject ombitasvir Small molecule 25 mg —
Subject paritaprevir Small molecule 150 mg —