Chronic Hepatitis C virus infection MedDRA version: 19.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 19.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Harvoni 90 mg/400 mg film-coated tablets
Product Name: Ledipasvir/Sofosbuvir FDC
Product Code: GS-5885/GS-7977 FDC
Pharmaceutical Form: Film
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. 1) Willing and able to provide written informed consent 2) Male or female age = 18 years 3) Chronic HCV infection (= 6 months) as documented by prior medical history or liver biopsy 4) HCV RNA = LLOQ at screening 5) Genotype 1,4, 5 and 6 HCV as determined at Screening 6) End stage renal disease (ESRD) requiring peritoneal dialysis (PD) or hemodialysis (HD) 7)he most recent HCV treatment must have been completed at least 8 weeks prior to Screening. 8) Subjects must have a determination of treatment experience (treatment naïve vs. treatment experienced). Treatment naïve is defined as having never been exposed to an approved or experimental HCV-specific direct acting antiviral agents or prior treatment of HCV with interferon or ribavirin. All other patients will be considered treatment experienced. 9) Subjects must have appropriate testing for determination of cirrhosis status. a) Presence of cirrhosis is defined as any one of the following: i) Fibroscan with a result of > 12.5 kPa ii) Liver biopsy showing cirrhosis (e.g., Metavir score = 4 or Ishak score = 5) iii) In the absence of liver biopsy or availability of Fibroscan, FibroTest® score = 0.75 at screening b) Absence of cirrhosis is defined as any one of the following: i) Fibroscan with a result of = 12.5 kPa within = 6 months of Baseline/Day 1 ii) Liver biopsy performed within 2 years of Screening showing absence of cirrhosis iii) In the absence of liver biopsy or availability of Fibroscan, FibroTest® score 100 cells/mm3 prior to Screening. Subjects with an isolated or unconfirmed HIV RNA >50 copies/mL (or >LLOQ if the local laboratory assay’s LLOQ is 50= copies/mL) are not excluded ii) On a stable ARV regimen for = 8 weeks prior to Screening and is expected to continue the current ARV regimen through the end of study (See exclusion criteria 7). 12) A negative serum pregnancy test is required for female subjects (unless permanently sterile or greater than two years post-menopausal). 13) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 4. 14) Lactating females must agree to discontinue nursing before the study drug is administered. 15) Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments Are the trial subjects under 18
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in this study. 1) Current or prior history of any of the following: a) Clinically-significant illness (other than HCV, HIV and kidney disease or co-morbidities associated with ESRD except as noted below) any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness (other than HCV or ESRD) are also excluded. b) Current or prior history of significant cardiac disease including or resulting in: ? Hospital admission for significant cardiovascular disease (myocardial infarction, unstable angina, heart failure, hypertensive emergency) or has had a cardiovascular procedure (e.g. CABG or PTCA), within 6 months of Screening ? Cardiomyopathy with ejection fraction 10 X the upper limit of normal (ULN) b) AST > 10 X ULN c) Direct bilirubin > 1.5 X ULN. For subjects receiving ritonavir boosted atazanavir regimen, a direct bilirubin > 1.5 x ULN will be allowed if 9% f) Hemoglobin 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR i) Hepatitis B surface antigen positive 9
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To determine the proportion of subjects who attain SVR at 4 and 24 weeks after cessation of each study treatment regimen (SVR4 and SVR24) ? To evaluate the proportion of subjects with virologic failure ? To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of treatment ? To evaluate the emergence of viral resistance to LDV and SOF during treatment and after cessation of treatment ? To evaluate the steady-state pharmacokinetics of LDV and SOF and its metabolites in subjects who are on dialysis for ESRD ; Primary end point(s): The primary end point is SVR12 (HCV RNA < LLOQ 12 weeks after cessation of treatment) in the Full Analysis Set (FAS) population. The primary safety endpoint is any AE that led to permanent discontinuation of study drug. ;Timepoint(s) of evaluation of this end point: SVR 12 weeks; Main Objective: ? To evaluate the antiviral efficacy of treatment with LDV/SOF for 8,12, or 24 weeks in subjects with chronic hepatitis C virus (HCV) infection who are on dialysis for ESRD, as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR12) ? To evaluate the safety and tolerability of each treatment regimen | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: • SVR 4 and 24 weeks • PK Day 7 ; Secondary end point(s): Secondary endpoints include the following: ? The proportion of subjects with HCV RNA < LLOQ at 4 and 24 weeks after cessation of treatment (SVR4 and SVR24) ? The proportion of subjects with HCV RNA < LLOQ on treatment ? HCV RNA change from Baseline/Day 1 ? The proportion of subjects with virologic failure ? The proportion of subjects who develop viral resistance to LDV and SOF during treatment and after cessation of treatment ? The steady-state pharmacokinetics of LDV and SOF and its metabolites | — |
Countries
Belgium, Germany, Italy, Switzerland, Taiwan
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed