Status:
WITHDRAWN
A Prospective Cohort Study to Improve HCV Care in Dialysis Patients
Lead Sponsor:
Albert Einstein Healthcare Network
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Davita Clinical Research
Conditions:
Hepatitis C
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
Hepatitis C virus (HCV) infects an estimated 185 million individuals worldwide and 3.4 million to 4.4 million people in the United States. Approximately 80% of acutely infected HCV patients progress t...
Detailed Description
This study is being conducted to evaluate real-world effectiveness of HCV DAA therapy in CHC hemodialysis patients when the DAA-treatment is managed and monitored by the nephrologist of hemodialysis c...
Eligibility Criteria
Inclusion
- Be 18 years of age or older on day of signing the informed consent form.
- Be on long term hemodialysis at any of the selected 4 collaborative hemodialysis centers
- Have positive anti-HCV antibody titers and detectable HCV RNA level before or after the initiation of MATCH-D.
- HCV genotype 1 and 4
- Have an HCV treatment status that is one of the following:
- Treatment naïve: Naive to all anti-HCV treatment
- Prior IFN or PEG-IFN + Ribavirin Treatment failures: Null responders, Partial responders, Relapsers
- P/R Intolerant: Subjects were intolerant to a prior IFN or PEG-IFN
- Ribavirin regimen, Subjects discontinued treatment prematurely and were therefore unable to complete a full course of therapy because of drug-related toxicity.
Exclusion
- Has evidence of decompensated chronic liver disease such as presence of or history of - ascites, gastric or variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease
- Have Child-Pugh B or C cirrhosis (these patients will need to be referred to a hepatologist for HCV therapy)
- Have a likelihood of receiving a renal transplant or liver transplant during the study treatment period.
- Have hepatocellular carcinoma
- Have other liver disease (which require HCV therapy to be delivered under the supervision of a hepatologist)
- A patient with a life expectancy less than 12 months
- Current untreated chronic hepatitis B infection HBsAg+ patients are excluded. Note: Patients with HBcAb+ will not be excluded, but will have HBV DNA levels checked and will be monitored while on DAA therapy and medically managed as considered appropriate by the PI.
- Have HIV and currently not under Antiretroviral Therapy (ART)
- Pregnant or nursing (lactating) women
- Albumin below 3g/dL
- Platelet count below 75,000
- Unable to comply with research study visits
- Poor venous access not allowing screening laboratory collection
- Have any condition that the investigator considers a contraindication to study participation
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03791814
Start Date
January 1 2019
End Date
June 30 2019
Last Update
February 26 2020
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