- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02597166
Effects of Harvoni in Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 Infection
The Effects of Anti-Viral Therapy on the Clinical Status, Quality of Life, and Survival of Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 Infection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hepatitis C virus (HCV) is one of the most common causes of liver cirrhosis worldwide. The progression of liver cirrhosis can lead to a myriad of complications including ascites, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, and hepatocellular carcinoma. The development of these complications or decompensation can lead to a dismal survival of 50% at 6 months, especially if the underlying cause of the liver cirrhosis is not treated. The cost of caring for these patients with decompensated cirrhosis is extremely high. Despite this, every effort is being made to maintain these patients in reasonable health until liver transplant becomes available for them. Yet these patients continue to have poor quality of life because of the various symptoms related to decompensated cirrhosis, and spend much time visiting health care facilities for both outpatient and inpatient care.
The recent availability of potent and effective anti-viral therapy has revolutionized the management of patients with hepatitis C infection. With a >90% cure rate, many patients with compensated cirrhosis, once treated, will not progress further to develop decompensation. With the passage of time, the liver cirrhosis may even regress to a non-cirrhotic state. Published data on treatment of decompensated cirrhosis with hepatitis C infection is still scanty. However, patients with decompensated cirrhosis due to hepatitis B infection who received effective anti-viral therapy not only improved their overall clinical status, many of these patients reverted from a decompensated to a compensated state, associated with improved survival. Likewise, patients with alcoholic cirrhosis who abstain from alcohol will also have improvement in liver function and reduction in complications of cirrhosis. Therefore, treatment of decompensated cirrhotic patients with hepatitis C is expected to show the same beneficial effects, because the underlying cause of cirrhosis is coming under control.
The primary objective of this study is to assess the effects of anti-viral therapy on the clinical status, quality of life and survival of patients with decompensated cirrhosis due to chronic hepatitis C genotype 1 infection.
After completion of all initial investigations, patients will be started on Harvoni 90 mg ledipasvir/400 mg sofosbuvir (one tablet) daily. The course of treatment will be 24 weeks. Patients will be reviewed at monthly intervals as per standard of care. At each clinic visit, patients with have blood tests including complete blood count, renal function, electrolytes, liver enzyme and liver function tests, HCV RNA will be done at week 4, week 12, week 24 during treatment, and then again at week 12 post completion of treatment. Annual ultrasounds and surveillance gastroscopies will be organized as per standard of care.
Patient will be followed for 1 year post completion of treatment, and have repeat quality of life questionnaires at end of treatment, and thereafter at 6 and 12 months. Patients will also be monitored for the development of further complications of cirrhosis (if any), hospital admissions, reasons for hospital admissions, lengths of hospital stays, survival, and liver transplantation.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- University Health Network - Toronto General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Ledipasvir/Sofosbuvir
Each tablet contains 90 mg ledipasvir and 400 mg sofosbuvir, given orally, once daily for 24 weeks.
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Each tablet of Harvoni contains 90 mg ledipasvir and 400 mg sofosbuvir.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of quality of life based on Chronic Liver Disease Questionnaire
Time Frame: one year
|
Improvement of quality of life based on Chronic Liver Disease Questionnaire
|
one year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Florence Wong, MD, University Health Network - Toronto General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Fibrosis
- Hepatitis
- Hepatitis A
- Hepatitis C
- Liver Cirrhosis
- Hepatitis C, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Sofosbuvir
- Ledipasvir, sofosbuvir drug combination
- Ledipasvir
Other Study ID Numbers
- IN-CA-337-1960
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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