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Effects of Harvoni in Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 Infection

NCT02597166 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-10-25

No results posted yet for this study

Summary

There are now several licensed drug treatments for patients with HCV infection. These medications have been shown to be very effective in getting rid of the virus in patients with HCV infection including those with early stages of cirrhosis without complications known as compensated cirrhosis, with a greater than 90% cure rate. At present, there are very little data to show that treating patients with HCV infection and decompensated cirrhosis will give the same effects. However, patients with decompensated cirrhosis as a result of hepatitis B infection who received treatment to control their virus show improvement of their overall liver condition, and the liver complications of many of these patients disappeared. Also, patients with cirrhosis due to excess alcohol and who stopped drinking also showed improvement in liver function and their complications of cirrhosis coming under control. Therefore, treatment of patients with HCV infection and decompensated cirrhosis is expected to show the same positive effects, because the underlying cause of cirrhosis is coming under control. Harvoni is a combination of two direct-acting antivirals (ledipasvir and sofosbuvir) that prevents the hepatitis C virus from copying and multiplying themselves, allowing the body to clear the virus from their systems and be cured of HCV infection. This study is being conducted to find out if treatment with Harvoni will lead to clearance of HCV infection in patients with decompensated cirrhosis giving rise to improvement in liver function, together with improvement of quality of life and survival.

Conditions

  • Hepatitis C, Chronic
  • Cirrhosis, Decompensated

Interventions

DRUG

Ledipasvir/Sofosbuvir

Each tablet of Harvoni contains 90 mg ledipasvir and 400 mg sofosbuvir.

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Florence Wong, MD · University Health Network - Toronto General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02597166 on ClinicalTrials.gov