Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816

Completed · Phase 2

Conditions studied: Chronic Hepatitis C

In brief

Background: \- Chronic hepatitis C is a serious liver disease. Current treatments have side effects. New drugs have been developed, but they work better in some people than others. Researchers want to learn why. Objective: \- To learn why new hepatitis C drugs sometimes do not work. Also, to learn if these drugs are safe and how well they work in people with different virus strains. Eligibility: \- Adults age 18 and older who are infected with hepatitis C virus genotypes 1-4 and who have either never been treated or treated previously with an interferon regimen (with or without ribavirin) that failed to clear the virus. Design: * Participants will be screened with medical history and physical exam. They will have blood and urine tests and complete questionnaires. * Participants will have a Fibroscan, an ultrasound that measures liver stiffness and other liver scans. They will have an electrocardiogram. * Eligible participants will have a liver biopsy. * Participants will be admitted to the Clinical Center. They will have a physical exam and blood tests, and complete questionnaires. * They will take the first study drug dose as a tablet taken once daily. * Participants will take the drug at home for 12 weeks. * Participants will have 6 study visits. They will have blood and vital signs taken, and complete questionnaires. * At week 4, participants will have another liver biopsy. * After their last drug dose, participants will have 5 follow-up visits. They will have blood and vital signs taken, and complete questionnaires. They will discuss their medications and side effects. They may have another Fibroscan.

Key facts

Study ID

NCT02468648

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

72

Starts

2015-06-09

Expected to finish

2018-09-14

Last updated by the study team

2020-03-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects who meet any of the following exclusion criteria will not to be enrolled in this study.
• Current or prior history of any of the following:
• 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.
• Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug.
• Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
• Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).
• Solid organ transplantation.
• Significant pulmonary disease, significant cardiac disease or porphyria.
• Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years. Subjects with psychiatric illness (without the prior mentioned conditions) that is well-controlled on a stable treatment regimen for at least 12 months prior to randomization or has not required medication in the last 12 months may be included.
• Malignancy within 5 years prior to screening, with the exception of specific cancers that are entirely cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible.
• Significant drug allergy (such as anaphylaxis or hepatotoxicity).
• Any prior treatment with a direct acting antiviral agent (protease inhibitors, NS5A inhibitors and NS5B polymerase inhibitors/non-nucleoside polymerase inhibitors.)
• Pregnant or nursing female or male with pregnant female partner.
• Chronic liver disease of a non HCV etiology (e.g., hemochromatosis, Wilson s disease, alfa 1 antitrypsin deficiency, cholangitis).
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
• Clinically-relevant 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.
• Use of any prohibited concomitant medications as described within 21 days of the Baseline/Day 1 visit; this washout period does not apply to PPIs, which can be taken up to 7 days before baseline Day 1.
• Use of antiviral medications within the last 30 days.
• Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day).
• Known hypersensitivity to GS-5816, SOF, or formulation excipients.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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