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Completed

NCT Number: NCT02702739

Sofosbuvir/Simeprevir Plus a Flat Dose of Ribavirin in Genotype 1 Elderly HCV Cirrhotic Patients

The proportion of HCV infected patients over age 65 years in Western countries is increasing. This growth and the advent of new antiviral therapy bring into the question the real world efficacy and safety of the combination of Sofosbuvir and Simeprevir (SOF/SMV) plus a flat dose of ribavirin (RBV) in elderly patients compared to younger patients.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AO San Camillo Forlanini

Rome, Italy, 00142

About this study

The proportion of HCV infected patients over age 65 years in Western countries is increasing. This growth and the advent of new antiviral therapy bring into the question the real world efficacy and safety of the combination of Sofosbuvir and Simeprevir (SOF/SMV) plus a flat dose of ribavirin (RBV) in elderly patients (Group II) compared to younger patients (Group I) Multicenter, real world investigation study of once daily treatment with SOF 400 mg + SMV 150 mg with a flat dose of RBV 800 mg/day for a duration of 12 weeks in treatment naïve or experienced HCV genotype 1-infected patients with compensated cirrhosis.To evaluate efficacy, tollerability and safety of SOF/SMV/RBV in two different Group of patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Naive or experienced patients with genotype 1 compensated cirrhosis

Exclusion criteria

  • HIV and hepatitis B infection, active hepatocellular carcinoma (HCC), decompensated cirrhosis, history of organ transplant, severe psychiatric disorders or treatment with drugs that showed an interaction with antiviral treatment.

Treatment and study plan

Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks

Drug

Sofosbuvir 400 mg/day/Simeprevir 150 mg/day /Ribavirin 800/day for 12 weeks

Other names: Sovaldi Olysio Copegus

Primary outcomes

  1. Sustained virological response week 12 after the end of treatment

    Time frame: up 12 weeks

    to evaluate the efficacy in term of sustained virological response after 12 weeks from the end of treatment in the two Groups of patients

Secondary outcomes

  1. Adverse events and severe adverse events during the treatment period

    Time frame: up 12 weeks

    To report Adverse events and severe adverse events during the treatment period in the two Groups of patients

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera San Camillo Forlanini

Other

Registry information

Official study title

Efficacy and Safety of Sofosbuvir/Simeprevir Plus a Flat Dose of Ribavirin in Genotype 1 Elderly Cirrhotic Patients: a Real Life Study

Acronym: HCV

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Mar 9, 2016
Registry last updated
Mar 9, 2016

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.

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