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

NCT02468648 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2020-03-19

Study results available
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Summary

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.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

Sofosbuvir

An NS5B polymerase inhibitor that is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection

DRUG

GS-5816

An NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus.

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Marc G Ghany, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-09
Primary Completion
2018-09-14
Completion
2018-09-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02468648 on ClinicalTrials.gov