Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia
ID Number 15-2282Principal Investigator(s)
Peter D Gorevic
Department(s) or Division(s)
The purpose of this study is to evaluate the safety and effectiveness of Ledipasvir/Sofosbuvir 90mg/400mg daily in subjects with chronic genotype 1 Hepatitis C virus (HCV) infection with symptoms of cryoglobulinemia: joint pain, vasculitis (inflammation of blood vessels), glomerulonephritis (kidney disease causing protein loss in the urine and high blood pressure), Sjogrens syndrome (dry eyes and mouth), or neuropathy (nerve damage).
Subjects may qualify to take part in this research study because they have genotype 1 chronic hepatitis C infection and cryoglobulinemia.
Funds for conducting this research are provided by Gilead Sciences who is the financial sponsor for this study as well as the manufacturer of the study drug.
Subject participation in this research study is expected to last up to 13 months, allowing a one month screening process, 12 or 24 weeks of medication, and post-treatment monitoring for long-term effects.
This study is open to any subject with chronic genotype 1 HCV infected, male and non-pregnant female subjects, ages 18 or older with cryoglobulinemia as determined by clinical symptoms and laboratory testing. Mount Sinai Health Care System is the only site participating in this study.
The number of people expected to take part in this research study at Mount Sinai Health Care System is 10.
This is an "open-label" study, which means both the subject and the study doctor will know what study drugs the subject is taking. All patients will receive treatment with a FDA approved medication called Harvoni®, which includes two different drugs in the same pill: Ledipasvir (LDV) and Sofosbuvir (SOF).
- Group 1: subjects that have never been treated before for hepatitis C, and subjects that have been treated before for hepatitis C and do not have cirrhosis:
- 12 weeks of LDV/SOF (90mg/400mg) one tablet once daily
- Group 2: subjects that have been treated before for hepatitis C and have cirrhosis:
- 24 weeks of LDV/SOF (90mg/400mg) one tablet once daily
Recruiting Patients: Yes