NCT03549832

Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure

Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin Versus Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin in the Management of Hepatitis C Patients Fauilre to Prior Sofosbuvir/ Daclatasvir (An Open-labeled Randomized Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Now many cases reported failure to HCV treatment with Sofosbuvir/ Daclatasvir. retreat those patients is challenging. So, we aimed to Study the efficacy and safety of Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to prior Sofosbuvir/ Daclatasvir regimens in an open-labeled randomized trial.

Detailed description

HCV management with new DAAs is now promising. However, many cases reporting treatment failure either non-responder or relapse to HCV treatment with Sofosbuvir/ Daclatasvir. retreat those patients is challenging. So, we aimed to Study the efficacy and safety of Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to prior Sofosbuvir/ Daclatasvir regimens in a multicenter open-labeled randomized trial.

Conditions

• HCV Coinfection

Interventions

Type	Name	Description
DRUG	Sofosbuvir	Sofosbuvir 400 mg oral pills
DRUG	Simeprevir	Simeprevir 150 mg oral pills
DRUG	Daclatasvir	Daclatasvir 60 mg oral pills
DRUG	Ribavirin	Ribavirin 200 mg oral pills
DRUG	Ombitasvir/paritaprevir/ritonavir	Ombitasvir/paritaprevir/ritonavir oral pills

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-01-30
• Completion: 2019-01-30
• First posted: 2018-06-08
• Last updated: 2019-03-19

Locations

1 site across 1 country: Egypt