Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Willing and able to provide written informed consent or for those individuals where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative (LAR) willing and able to provide consent on behalf of the individual.
HCV RNA infection with quantifiable virus at screening
Must have chronic genotype 1 or 4 HCV infection for ≥ 6 months by medical history or liver biopsy
Currently on the liver transplantation wait list
Screening electrocardiogram (ECG) without clinically significant abnormalities.
A negative serum pregnancy test result is required for females
You may not be if
Any previous solid organ transplant
Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with participant's treatment, assessment, or compliance
HIV infection or a positive hepatitis B virus surface antigen result
History of malignancy (with exception of hepatocellular carcinoma within Milan criteria, certain resolved skin cancers or other early cancer for which surgical resection is considered to be completely curative)
Treatment with any approved or experimental medication with known anti-HCV activity within 1 month prior to screening date
Prior exposure to an HCV non-structural protein (NS)5A inhibitor
Patients on hemodialysis prior to or at the time of transplantation will be excluded
Creatinine clearance (CLcr) \< 40 mL/min at screening or \< 40 mL/min on day of transplant
Participation in a clinical study with an investigational drug or biologic within 28 days prior to screening visit
Receipt or planned receipt of an organ from an HCV positive donor
