Status:
COMPLETED
Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C
Hemodialysis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a study to define strategies for Nephrologists to directly supervise and apply direct acting antivirals to cure hepatitis C in hemodialysis patients. Strategies will include identification of ...
Detailed Description
Background - Hepatitis C (HCV) is common in hemodialysis (HD) patients with reported prevalences of 25%, By 2020, predicted 775,000 hemodialysis patients in the US, of whom 109,000 will have HCV. Hepa...
Eligibility Criteria
Inclusion
- Hemodialysis patient
- \> age 18 years old
- Hepatitis C antibody positive and Hepatitis C RNA Quantification positive
- Hepatitis C genomes 1a, 1b, or 4
- Prior Interferon , ribavirin treatment failures , partial responders, or intolerance to these treatment allowed to enroll
- Not of reproductive potential - hemodialysis patients must have no menses for 12 months
- Males with partners of reproductive potential as along a 2 reliable forms of contraception are used simultaneously during treatment and for 6 months after completion of treatment
- Ability to understand the study procedures, alternative treatments available, risks of participating in the study, and voluntarily agree to participate
Exclusion
- Currently undergoing active treatment for HCV with a direct acting antiviral or have previously successfully been treated with a direct acting antiviral
- Have moderate or severe hepatic disease - Child-Pugh B or C
- Have evidence of decompensated liver disease manifested by ascites, gastric or variceal bleeding, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
- Co-administration of known heaptotoxic drugs including but not limited to : etofoxine, isoniazid, nitrofurantoin, phenytoin
- Use of strong CYP3A/P-gp inhibitors, organic acid transporting polypeptide 1B1/3 inhibitors, strong inducers of cytochrome 450 3A (CYP3A), efavirenz, or other drugs which may interact with elbasvir/grazoprevir as per package insert
- history of substance abuse with alcohol, intravenous drugs, psychotropics, narcotics, cocaine use within 1 year of screening for study
- history of any condition, pre-study lab abnormality, or ECG abnormality or history of any illness which in the opinion of the investigators might confound the results of the study or pose additional risks from the administration of elbasvir/grazoprevir
- Have evidence of history of chronic hepatitis not caused by HCV including but not limited to nonalcoholic steatohepatitis (NASH), drug induced hepatitis, and autoimmune hepatitis
Key Trial Info
Start Date :
September 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03365635
Start Date
September 22 2019
End Date
September 1 2020
Last Update
December 15 2021
Active Locations (1)
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1
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19428