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
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Infectious Disease, Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/21/2018 |
Start Date: | May 22, 2015 |
End Date: | April 22, 2016 |
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic HCV for Use in the Peri-Operative Liver Transplantation Setting
The primary objective of this study is to evaluate the antiviral efficacy of treatment with
ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver
transplantation and through 4 weeks posttransplant in adults with genotype 1 or 4 hepatitis C
virus (HCV) infection who are undergoing primary liver transplantation.
ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver
transplantation and through 4 weeks posttransplant in adults with genotype 1 or 4 hepatitis C
virus (HCV) infection who are undergoing primary liver transplantation.
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
6
sites
Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials
