NCT02950870

Efficacy Study to Evaluate the Effect of New Antiviral Drugs on HCV Infection.

An Open-Label Study to Evaluate Long-Term Outcomes With Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Fertile Women With Genotype 1 and 4 Chronic Hepatitis C Virus (HCV) Infection

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: University of Modena and Reggio Emilia · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determinate the AMH levels before and after antiviral therapy with Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir in comparison with age-matched HCV-positive women not undergoing antiviral treatment.

Detailed description

The study is interventional, controlled randomized (block 2:1 case: controls) in open label.

Conditions

• Chronic Hepatitis, C Virus

Interventions

Type	Name	Description
DRUG	Ombitasvir-Paritaprevir-Ritonavir	The patient will be treated daily with Ombitasvir-Paritaprevir-Ritonavir 25/150/100 mg total dose
DRUG	Dasabuvir	The patient will be treated daily with Dasubavir 500 mg total dose
DRUG	Ribavirin	Patients will be treated with ribavirin if necessary.

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-12-01
• Completion: 2019-12-01
• First posted: 2016-11-01
• Last updated: 2016-11-01

Locations

1 site across 1 country: Italy