EUCTR2015-003455-21-FRActive, not recruitingPhase 1
A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects with Chronic HCV Infection
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Gilead Sciences, Inc.
- Enrollment
- 416
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1) Willing and able to provide written informed consent
- •2) Male or female, age =18 years
- •3) Body mass index (BMI) = 18 kg/m2
- •4) HCV RNA = 104 IU/mL at Screening
- •5) Chronic HCV infection (= 6 months) documented by prior medical history or liver biopsy.
- •6) Treatment experienced with an NS5A inhibitor-containing regimen of at least a 4-week duration
- •a) The most recent treatment must have been completed at least 8 weeks prior to Screening
- •b) Subjects must not have discontinued the most recent regimen due to either an adverse
- •event or virologic failure due to noncompliance
- •c) The subject’s medical records must include sufficient detail of prior treatment(s) to
- •confirm eligibility
- •7) Cirrhosis Determination
- •a) Presence of cirrhosis is defined as any one of the following:
- •i) FibroTest® score > 0.75 and AST:platelet ratio index (APRI) > 2 during Screening
- •ii) Liver biopsy showing cirrhosis (e.g., Metavir score = 4 or Ishak score =5)
- •iii) Transient elastography (FibroScan®) with a result of > 12.5 kPa
- •b) Absence of cirrhosis is defined as any one of the following, unless the definition of
- •cirrhosis has been met:
- •i) FibroTest® score = 0.48 and APRI = 1 performed during Screening
- •ii) Liver biopsy within 2 years of Screening showing absence of cirrhosis
- •iii) Transient elastography (FibroScan®) with a result of = 12.5 kPa within 6 months of Day 1
- •8) Liver imaging within 6 months prior to Day 1 is required in cirrhotic subjects to exclude
- •hepatocellular carcinoma (HCC)
- •9) Females of childbearing potential (as defined in Appendix 4) must have a negative serum
- •pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to enrollment
- •10) 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
- •11) Lactating females must agree to discontinue nursing before starting study drug.
- •12) Subject must be of generally good health, with the exception of chronic HCV infection, as determined by the investigator
- •13) 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? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 342
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
Exclusion Criteria
- •1) Current or prior history of any of the following:
- •a) Clinically significant illness (other than HCV) or 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) are also excluded
- •b) Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug
- •c) Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
- •d) Hepatic decompensation (e.g., clinical ascites, encephalopathy, and/or variceal hemorrhage)
- •e) Solid organ transplantation
- •f) Significant cardiac disease
- •g) Unstable psychiatric condition including hospitalization, suicide attempt, and/or a period
- •of disability as a result of their psychiatric illness within 2 years prior to Screening
- •h) Malignancy within the 5 years prior to Screening, with the exception of specific cancers
- •that have been cured by surgical resection (e.g., basal cell skin cancer, etc.). Subjects
- •under evaluation for possible malignancy are not eligible
- •i) Significant drug allergy (e.g., hepatotoxicity)
- •2) Screening ECG with clinically significant abnormalities
- •3) Subject has the following laboratory parameters at Screening:
- •a) ALT > 10 × the upper limit of normal (ULN)
- •b) AST > 10 × ULN
- •c) Direct bilirubin > 1.5 × ULN
- •d) Platelets < 50,000/?L
- •e) HbA1c > 8.5%
- •f) Creatinine clearance (Crcl) < 50 mL/min as calculated by the Cockcroft-Gault equation
- •g) Hemoglobin < 10 g/dL
- •h) Albumin < 3 g/dL
- •i) International Normalized Ratio of prothrombin time (INR) > 1.5 × ULN unless subject
- •has known hemophilia or is stable on an anticoagulant regimen affecting INR
- •4) Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease,
- •alfa-1 antitrypsin deficiency, cholangitis)
- •5) Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •6) Clinically-relevant alcohol or drug abuse within 12 months of Screening. A positive drug
- •screen will exclude subjects unless it can be explained by a prescribed medication; the
- •diagnosis and prescription must be approved by the investigator
- •7) Use of any prohibited concomitant medications as described in Section 5.5
- •8) Known hypersensitivity to the study drug, the metabolites, or formulation excipient
Investigators
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