Phase 2 N=72 Treatment

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

Chronic Hepatitis C

Bottom Line

View on ClinicalTrials.gov: NCT02468648 ↗

Enrolled (actual)

Serious AEs

2.8%

Results posted

Mar 2020

Primary outcome: Primary: Number of Participants With Sustained Virologic Response — 70 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Sofosbuvir (Drug); GS-5816 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Sustained Virologic Response	70	—
PRIMARY Number of Participants Who Maintained HCV RNA Levels in Liver and Serum Less Than Lower Limit of Quantification (LLOQ)	70	—
SECONDARY Number of Participants Who Sustained Virologic Response	70	—
SECONDARY Number of Participants Who Maintained HCV RNA Levels in Liver and Serum Less Than Lower Limit of Quantification (LLOQ)	70	—

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.

Eligibility Criteria

INCLUSION CRITERIA:

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.

Willing and able to provide written informed consent.
Male or female, age greater than or equal to18 years.
Body mass index (BMI) greater than or equal to 18 kg/m^2.
HCV RNA greater than or equal to10^4 IU/mL at Screening
HCV genotypes 1a, 1b, 2, 3 or 4 at screening
Confirmation of chronic HCV infection documented by either:
A positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or
A liver biopsy performed within 12 weeks prior to the Baseline/Day 1 visit with evidence of chronic HCV infection. A prior biopsy would be acceptable if performed with 12 weeks AND liver tissue stored in RNALater was available.
Screening ECG without clinically significant abnormalities.
Subjects must have the following laboratory parameters at screening:
ALT less than or equal to 10 times the upper limit of normal (ULN)
AST less than or equal to 10 times ULN
Direct bilirubin less than or equal to 1.5 ULN
Platelets > 70,000
HbA1c less than or equal to8.5%
eGFR greater than or equal to 60 mL /min, as calculated by the CKD-EPI equation.
Hemoglobin greater than or equal to 10g/dL.
Albumin greater than or equal to 3g/dL
INR less than or equal to 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.
A female subject is eligible to enter the study if it is confirmed that she is:
Not pregnant or nursing
Of non-childbearing potential (i.e., women who have had a hysterectomy, have both ovaries removed or medically documented ovarian failure, or are postmenopausal women > 50 years of age with cessation (for greater than or equal to 12 months) of previously occurring menses),

Of childbearing potential (i.e., women who have not had a hysterectomy, have not had both ovaries removed, and have not had medically documented ovarian failure). Women less than or equal to 50 years of age with amenorrhea will be considered to be of childbearing potential. These women must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on the Baseline/Day 1 visit prior to randomization. They must also agree to one of the following from 3 weeks prior to Baseline/Day 1 until 90 days after last dose of study drug:
Complete abstinence from intercourse. Periodic abstinence from intercourse (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not permitted.
Consistent and correct use of 1 of the following methods of birth control listed below in addition to a male partner who correctly uses a condom from the date of Screening until 90 days after last dose of study drug:
intrauterine device (IUD) with a failure rate of 10 mg/day).
Known hypersensitivity to GS-5816, SOF, or formulation excipients.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02468648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.