Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection
Phase 1b, Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-9857 in Subjects With Chronic Hepatitis C Virus Infection
1 other identifier
interventional
101
2 countries
11
Brief Summary
The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2014
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 13, 2014
CompletedFirst Submitted
Initial submission to the registry
July 7, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2015
CompletedResults Posted
Study results publicly available
August 21, 2020
CompletedSeptember 17, 2020
August 1, 2020
6 months
July 7, 2014
August 6, 2020
August 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Participants Experiencing Treatment Emergent Adverse Events
First dose date up to Day 3 plus 30 days
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant.
First dose date up to Day 3 plus 30 days
Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA
The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). Data are summarized by treatment/cohort and placebo.
Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48
Secondary Outcomes (3)
Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48
Baseline (Pre Day 1 Dose); Days 4, 5, 6, 7, 8, 10, and Week 48
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48
Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND)
Days 4, 5, 6, 7, 8, 10, and Week 48
Study Arms (16)
Placebo (GT 1a, Cohort 1)
PLACEBO COMPARATORParticipants with genotype (GT) 1a HCV infection will receive placebo once daily for 3 days under fasted conditions.
Voxilaprevir 50 mg (GT 1a, Cohort 1)
EXPERIMENTALParticipants with GT 1a HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions.
Voxilaprevir 100 mg (GT 1a, Cohort 1)
EXPERIMENTALParticipants with GT 1a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Voxilaprevir 300 mg (GT 1a, Cohort 1)
EXPERIMENTALParticipants with GT 1a HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions.
Placebo (GT 3, Cohort 2)
PLACEBO COMPARATORParticipants with GT 3 HCV infection will receive placebo once daily for 3 days under fasted conditions.
Voxilaprevir 50 mg (GT 3, Cohort 2)
EXPERIMENTALParticipants with GT 3 HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions.
Voxilaprevir 100 mg (GT 3, Cohort 2)
EXPERIMENTALParticipants with GT 3 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Voxilaprevir 300 mg (GT 3, Cohort 2)
EXPERIMENTALParticipants with GT 3 HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions.
Placebo (GT 2, Cohort 3)
PLACEBO COMPARATORParticipants with GT 2 HCV infection will receive placebo once daily for 3 days under fasted conditions.
Voxilaprevir 100 mg (GT 2, Cohort 3)
EXPERIMENTALParticipants with GT 2 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Voxilaprevir 100 mg (GT 4, Cohort 4)
EXPERIMENTALParticipants with GT 4 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Voxilaprevir 100 mg (GT 1b, Cohort 5)
EXPERIMENTALParticipants with GT 1b HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)
EXPERIMENTALParticipants with GT 3a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fed conditions.
Voxilaprevir 600 mg (Cohorts 7-9)
EXPERIMENTALParticipants with genotypes 1a, 1b, 2, 3, or 4 HCV infection will receive voxilaprevir up to 600 mg under fasted or fed conditions for 3 days.
Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10)
EXPERIMENTALParticipants with any GT HCV infection received voxilaprevir 100 mg on Day 1 after moderate fat meal and voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC)on Days 2 and 3 after either a light or moderate-fat meal.
Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10)
EXPERIMENTALParticipants with any GT HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal.
Interventions
Voxilaprevir tablets administered orally once daily
Placebo to match voxilaprevir tablets administered orally once daily
400 mg/100 mg FDC tablet administered orally once daily
Eligibility Criteria
You may qualify if:
- Chronic genotype 1-4 HCV infection
- For Cohorts 1-9, HCV RNA ≥ 100,000 IU/mL at screening (no HCV RNA restriction for Cohort 10)
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
You may not qualify if:
- Pregnant or nursing female or male with pregnant female partner
- Presence of cirrhosis
- Prior exposure to approved or experimental HCV Protease Inhibitors
- Co-infection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may interfere with participant's treatment, assessment or compliance with the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (11)
Unknown Facility
Costa Mesa, California, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Berlin, New Jersey, United States
Unknown Facility
Marlton, New Jersey, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Knoxville, Tennessee, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
San Juan, Puerto Rico
Related Publications (2)
Rodriguez-Torres M, Glass S, Hill J, Freilich B, Hassman D, Di Bisceglie A, Taylor J, Kirby B, Yang J, An D, Stamm L, Brainard D, Kim S, Krefetz D, Smith W, Marbury T, Lawitz E. The Pangenotypic NS3/4A Protease Inhibitor GS-9857 Demonstrates Potent Antiviral Activity in Patients Infected With HCV Genotype 1, 2, 3, or 4 in a 3-Day Monotherapy Study [Poster P0901]. Presented at the European Association for the Study of the Liver (EASL) 50th International Liver Congress 2015, April 22-26, 2015, Vienna, Austria.
RESULTLawitz E, Yang JC, Stamm LM, Taylor JG, Cheng G, Brainard DM, Miller MD, Mo H, Dvory-Sobol H. Characterization of HCV resistance from a 3-day monotherapy study of voxilaprevir, a novel pangenotypic NS3/4A protease inhibitor. Antivir Ther. 2018;23(4):325-334. doi: 10.3851/IMP3202.
PMID: 29063860RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2014
First Posted
July 10, 2014
Study Start
June 13, 2014
Primary Completion
December 22, 2014
Study Completion
September 28, 2015
Last Updated
September 17, 2020
Results First Posted
August 21, 2020
Record last verified: 2020-08