A trial investigating the safety and efficacy of a drug combination Sofosbuvir/Velpatasvir/GS-9857 for subjects with hepatitis C
- Conditions
- Chronic Hepatitis C virus infectionMedDRA version: 18.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 18.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-003455-21-FR
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 416
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
Appendix 4
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
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
{2202}
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method