An international study to assess the safety and efficacy of a combination of new investigational drugs in patients with chronic hepatitis C virus infection.
- Conditions
- Chronic Genotype 1 Hepatitis C Virus InfectionMedDRA version: 15.1Level: LLTClassification code 10019751Term: Hepatitis C virusSystem Organ Class: 100000004848Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-003387-43-DE
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
1) Willing and able to provide written informed consent
2) Male or female, age = 18 years
3) Body mass index (BMI) = 18
4) HCV RNA = 104 IU/mL at Screening
5) HCV treatment-naïve
6) HCV genotype 1a, 1b, or mixed 1a/1b at Screening.
7) Confirmation of chronic HCV infection
8) Cirrhosis determination [up to 20% of study subjects may have cirrhosis]
9) Liver imaging within 6 months of Baseline/Day 1 to exclude hepatocellular carcinoma (HCC) is required in patients with cirrhosis
10) Screening ECG without clinically significant abnormalities
12) Subject has not been treated with any investigational drug or device within 30 days of the Screening visit.
14) All male study participants must agree to consistently and correctly use a condom while their female partner agrees to use 1 highly effective method of birth control from the date of screening until 7 months after their last dose of RBV or 90 days after their last dose of study drug if not taking RBV.
15) Male subjects must agree to refrain from sperm donation from the date of screening until at least 7 months after the last dose of RBV or 90 days after their last dose of study drug if not taking RBV.
16) Subject must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator.
17) 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 720
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
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;
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) Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage);
e) Solid organ transplantation;
f) Significant pulmonary disease, significant cardiac disease or porphyria;
g) Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years;
h) Malignancy diagnosed or treated within 5 years;
i) Significant drug allergy (such as anaphylaxis or hepatotoxicity).
2) Pregnant or nursing female or male with pregnant female partner.
3) Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease, alpha-1 antitrypsin deficiency, cholangitis).
4) Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
5) Donation or loss of more than 400 mL blood within 2 months prior to Baseline/Day 1
6) Clinically-relevant drug abuse within 12 months of screening.
7) Alcohol misuse as defined by a Alcohol Use Disorders Identification Test (AUDIT) score = 8
8) Contraindications to RBV therapy, including significant history of clinically significant hemoglobinopathy (e.g., sickle cell disease, thalassemia).
9) Use of any prohibited concomitant medications within 21 days of the Baseline/Day 1 visit.
10) Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day).
11) Known hypersensitivity to RBV, GS-5885, sofosbuvir, or formulation recipients.
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