A trial investigating the safety and efficacy of the drug combination Sofosbuvir/Velpatasvir/GS-9857 for 12 weeks against Sofosbuvir/Velpatasvir for 12 weeks for subjects with hepatitis C

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: EUCTR2015-003167-10-FR
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-05
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 380

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 non-NS5A inhibitor DAA-containing regimen of at least a 4-week duration. Subjects whose sole DAA exposure was an NS3/4A protease inhibitor will be excluded.
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
8) Liver imaging within 6 months prior to Day 1 is required to exclude hepatocellular carcinoma (HCC)
9) Females of childbearing potential 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
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.
i. Significant drug allergy (e.g., hepatotoxicity)
2) Screening ECG with clinically significant abnormalities
3) Subjects with laboratory parameters at screening as defined in the protocol
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
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