“Real World” Administration of Zepatier (Grazoprevir plus Elbasvir in Chronic Hemodialysis Patients with Hepatitis C Infection. Strategies for Identification of Candidate Hemodialysis Patients, Obtainment of Insurance Approval, Treatment Guidelines, and Laboratory and Clinical Monitoring During Therapy Directed to Nephrologists
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- STATUS
- Enrolling By Invitation
Summary
The purpose of this study is to learn how to dialysis doctors can treat dialysis patients infected with Hepatitis C themselves. Hepatitis C infection is common in hemodialysis patients. There are new medications, such as Zepatier, which can cure hepatitis C in > 95% of patients. Zepatier is particularly good for hemodialysis patients with Hepatitis C since the drug is eliminated by the liver and not the kidney. Zepatier is currently approved by the Food and Drug Administration (FDA) to treat certain types of hepatitis C in dialysis patients. For most patients with hepatitis C, one pill per day of Zepatier for 12 weeks will be sufficient. However, there may be so patients who may require 16 weeks of therapy or the addition of another FDA approved drug called Ribavirin. If you need 16 weeks of treatment or the addition of Ribavirin you will be told at the screening visit. Routine testing of all the patients in your dialysis unit, has identified patients such as yourself, with blood studies that demonstrate a hepatitis C infection. If you choose to participate in this study, other testing will be done to see if you qualify. If you do qualify, you will be provided medication for treatment of your hepatitis C at no cost.
Details
| Condition | hep c, hepatitis C |
|---|---|
| Age | 18years - 80years |
| Clinical Study Identifier | TX6316 |
| Last Modified on | 19 February 2024 |
Eligibility
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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