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

NCT02597166 | Completed Phase 3

• 1 other identifier: IN-CA-337-1960
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Improvement of quality of life based on Chronic Liver Disease Questionnaire

  Improvement of quality of life based on Chronic Liver Disease Questionnaire

  one year

Study Arms (1)

Ledipasvir/Sofosbuvir

OTHER

Each tablet contains 90 mg ledipasvir and 400 mg sofosbuvir, given orally, once daily for 24 weeks.

Drug: Ledipasvir/Sofosbuvir

Interventions

Ledipasvir/Sofosbuvir DRUG

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

Also known as: Harvoni

Ledipasvir/Sofosbuvir

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment-naïve and treatment-experienced patients with CHC genotype 1 infection and decompensated cirrhosis as defined by one of the following:
• history of variceal bleeding
• presence or history of ascites
• history of grade III-IV hepatic encephalopathy
• Coagulopathy with an INR\>1.7
• Jaundice with a serum bilirubin of \>85µmol/L
• Cirrhosis is defined as any one of the following:
• A liver biopsy performed prior to the study showing cirrhosis (F4)
• Fibroscan performed within 12 calendar months of the start of this study with a result of \> 12.5 kPa
• A Fibrotest ® score of \>0.75

You may not qualify if:

• Patients older than 75 years
• Presence of hepatoma at entry
• Patients awaiting living-related liver transplantation
• MELD score of \>30
• Significant co-morbid condition(s) with a life expectancy of \<6 months
• HIV co-infection
• HBV co-infection

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Gilead Sciences: collaborator

Study Sites (1)

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Fibrosis

Interventions

ledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Florence Wong, MD

  University Health Network - Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Hepatologist, Professor Division of Gastroenterology, Department of Medicine University of Toronto

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 5, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 25, 2018

Record last verified: 2018-10

Locations

CA (1)