A trial looking at the treatment of Sofosbuvir/Velpatasvir in patients with hepatitis C infectio

Phase 1

Conditions: Chronic Hepatitis C Virus Infection
MedDRA version: 18.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2015-003001-42-SE

Lead Sponsor: Gilead Sciences, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

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) HCV RNA = to 104 IU/mL at Screening.
4) HCV genotype 1, 2, 3, 4, 5, 6 assessed at Screening by the Central Laboratory.
5) Chronic HCV infection (= 6 months) documented by prior medical history or liver biopsy.
6) Classification as treatment naïve or treatment experienced.
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.

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 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

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) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
2) Screening ECG with clinically significant abnormalities
3) Any of the following laboratory parameters at screening:
a) ALT > 10 x the upper limit of normal (ULN)
b) AST > 10 x ULN
c) Direct bilirubin > 1.5 x ULN
d) Platelets < 50,000/uL
e) HbA1c > 8.5%
f) Creatinine clearance (CLcr) < 60 mL /min as calculated by the Cockcroft-Gault equation
g) Hemoglobin < 11 g/dL for female subjects; < 12 g/dL for male subjects.
h) Albumin < 3 g/dL
i) INR > 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant
regimen affecting INR
4) Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor