Skip to main content
OpenTrials
Completed

NCT Number: NCT03549832

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HCV Coinfection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hopsital

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with proven CHC genotype 4
  • 18 years old or more,
  • prior HCV treatment failure to sofosbuvir /daclatasvir
  • compensated liver disease.

Exclusion criteria

  • Patients with combined HCV/HBV co-infection, hepatocellular carcinoma (HCC), decompensated liver cirrhosis (Child-Pugh score above 6), and non-genotype 4 were excluded.

Treatment and study plan

Sofosbuvir

Drug

Sofosbuvir 400 mg oral pills

Simeprevir

Drug

Simeprevir 150 mg oral pills

Daclatasvir

Drug

Daclatasvir 60 mg oral pills

Ribavirin

Drug

Ribavirin 200 mg oral pills

Ombitasvir/paritaprevir/ritonavir

Drug

Ombitasvir/paritaprevir/ritonavir oral pills

Primary outcomes

  1. SVR rate

    Time frame: 12 weeks

    The primary endpoint was the achievement of SVR at week 12 (SVR12) post-treatment. The potential adverse events were evaluated in each visit for the development of adverse events or any significant interactions.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Collaborators

  • Sohag University
  • South Valley University

Registry information

Official study title

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)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2018
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.