NCT01740791

Brief Summary

The primary objective of the study is to evaluate the safety, tolerability, and antiviral activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes 1-6.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2012

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2014

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

December 16, 2020

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

November 26, 2012

Results QC Date

October 27, 2020

Last Update Submit

December 11, 2020

Conditions

Chronic Hepatitis C Virus

Keywords

Hepatitis CHCVGenotype 1Genotype 2Genotype 3Genotype 4Genotype 5Genotype 6Liver Disease

Outcome Measures

Primary Outcomes (3)

  • Percentage of Participants Experiencing Treatment Emergent Adverse Events

    Treatment-emergent adverse events were defined as any new or worsening adverse event that began on or after the date of the first dose of study drug until the Day 17 study visit date + 2 (Day 19 if Day 17 visit missing).

    First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)

  • Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

    A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline at any postbaseline visit up to the Day 17 visit date + 2 days (or Day 19 if Day 17 visit was missing). The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), or Grade 3 (severe). Graded laboratory abnormalities were defined using the grading scheme defined in protocol (Gilead Sciences, Inc. Grading Scale for Severity of Adverse Events and Laboratory Abnormalities) for analysis purpose.

    First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)

  • Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline

    Participants who were genotyped incorrectly but received appropriate treatment for that genotype were included in that treatment group for the efficacy analysis. Data were summarized by treatment and placebo.

    Baseline; Days 4, 5, 6, 7, 8, 10, and 17

Secondary Outcomes (10)

  • Absolute HCV RNA Level

    Baseline; Days 4, 5, 6, 7, 8, 10, and 17

  • Number of Participants Achieving Reductions From Baseline in HCV RNA

    Baseline; Days 4, 5, 6, 7, 8, 10, and 17

  • Number of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected

    Days 4, 5, 6, 7, and 8

  • Plasma HCV RNA Levels by Treatment and IL28B Genotype

    Days 4, 5, 6, 7, 8, 10, and 17

  • Pharmacokinetic (PK) Parameter of Velpatasvir: AUCinf

    0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1

  • +5 more secondary outcomes

Study Arms (12)

Velpatasvir 5 mg (GT 1a)

EXPERIMENTAL

Participants with genotype (GT) 1a HCV infection will receive velpatasvir 5 mg or placebo once daily for 3 days under fasted conditions.

Drug: VelpatasvirDrug: Placebo

Velpatasvir 25 mg (GT 1a)

EXPERIMENTAL

Participants with GT 1a HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions.

Drug: VelpatasvirDrug: Placebo

Velpatasvir 50 mg (GT 1a)

EXPERIMENTAL

Participants with GT 1a HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions.

Drug: VelpatasvirDrug: Placebo

Velpatasvir 100 mg (GT 1a)

EXPERIMENTAL

Participants with GT 1a HCV infection will receive velpatasvir 100 mg or placebo once daily for 3 days under fasted conditions.

Drug: VelpatasvirDrug: Placebo

Velpatasvir 150 mg (GT 1a)

EXPERIMENTAL

Participants with GT 1a HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

Drug: VelpatasvirDrug: Placebo

Velpatasvir 150 mg (GT 1b)

EXPERIMENTAL

Participants with GT 1b HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

Drug: VelpatasvirDrug: Placebo

Velpatasvir 150 mg (GT 2)

EXPERIMENTAL

Participants with GT 2 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

Drug: VelpatasvirDrug: Placebo

Velpatasvir 25 mg (GT 3)

EXPERIMENTAL

Participants with GT 3 HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions.

Drug: VelpatasvirDrug: Placebo

Velpatasvir 50 mg (GT 3)

EXPERIMENTAL

Participants with GT 3 HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions.

Drug: VelpatasvirDrug: Placebo

Velpatasvir 150 mg (GT 3)

EXPERIMENTAL

Participants with GT 3 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

Drug: VelpatasvirDrug: Placebo

Velpatasvir 150 mg (GT 4)

EXPERIMENTAL

Participants with GT 4 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

Drug: VelpatasvirDrug: Placebo

Velpatasvir up to 400 mg (GT 2)

EXPERIMENTAL

Participants with GT 2 HCV infection will receive velpatasvir up to 400 mg or placebo once daily for 3 days under fasted conditions.

Drug: VelpatasvirDrug: Placebo

Interventions

VelpatasvirDRUG

Tablets administered orally

Also known as: GS-5816
Velpatasvir 100 mg (GT 1a)Velpatasvir 150 mg (GT 1a)Velpatasvir 150 mg (GT 1b)Velpatasvir 150 mg (GT 2)Velpatasvir 150 mg (GT 3)Velpatasvir 150 mg (GT 4)Velpatasvir 25 mg (GT 1a)Velpatasvir 25 mg (GT 3)Velpatasvir 5 mg (GT 1a)Velpatasvir 50 mg (GT 1a)Velpatasvir 50 mg (GT 3)Velpatasvir up to 400 mg (GT 2)
PlaceboDRUG

Tablets administered orally

Velpatasvir 100 mg (GT 1a)Velpatasvir 150 mg (GT 1a)Velpatasvir 150 mg (GT 1b)Velpatasvir 150 mg (GT 2)Velpatasvir 150 mg (GT 3)Velpatasvir 150 mg (GT 4)Velpatasvir 25 mg (GT 1a)Velpatasvir 25 mg (GT 3)Velpatasvir 5 mg (GT 1a)Velpatasvir 50 mg (GT 1a)Velpatasvir 50 mg (GT 3)Velpatasvir up to 400 mg (GT 2)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HCV treatment-naive adult participants (18-65 years of age) with chronic HCV infection and plasma HCV RNA ≥ 5 log10 IU/mL at screening
  • Agree to use protocol defined precautions against pregnancy

You may not qualify if:

  • Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
  • Evidence of cirrhosis
  • Evidence of current drug abuse
  • Screening laboratory results outside the protocol specified requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

West Coast Clinical Trials, LLC

Costa Mesa, California, 92626, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Kansas City Gastroenterology and Hepatology

Kansas City, Missouri, 64131, United States

Location

CRI Worldwide, LLC

Marlton, New Jersey, 08053, United States

Location

CRI Worldwide, LLC

Philadelphia, Pennsylvania, 19139, United States

Location

New Orleans Center for Clinical Research-Knoxville

Knoxville, Tennessee, 37920, United States

Location

Alamo Medical Research

San Antonio, Texas, 78215, United States

Location

Charles River Clinical Services Northwest, Inc.

Tacoma, Washington, 98418, United States

Location

Fundacion De Investigacion De Diego

San Juan, 00927, Puerto Rico

Location

Related Publications (4)

  • Hebner C, Gontcharova V, Chodavarapu RK, Rodriguez-Torres M, Lawitz E, Yang C, et al. Deep Sequencing of HCV NS5A From a 3-Day Study of GS-5816 Monotherapy Confirms the Potency of GS-5816 Against Pre-Existing Genotype 1-3 NS5A Resistance-Associated Variants [Abstract 470]. The Liver Meeting The 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2013 November 1-5; Washington, D.C.

    RESULT

  • Lawitz E, Glass SJ, Gruener D, Freilich B, Hill JM, Link JO, et al. GS-5816, a Once-Daily NS5A Inhibitor, Demonstrates Potent Antiviral Activity in Patients with Genotype 1, 2, 3, or 4 HCV Infection in a 3-Day Monotherapy Study [Abstract 1082]. The Liver Meeting The 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2013 November 1-5; Washington, D.C.

    RESULT

  • Lawitz EJ, Dvory-Sobol H, Doehle BP, Worth AS, McNally J, Brainard DM, Link JO, Miller MD, Mo H. Clinical Resistance to Velpatasvir (GS-5816), a Novel Pan-Genotypic Inhibitor of the Hepatitis C Virus NS5A Protein. Antimicrob Agents Chemother. 2016 Aug 22;60(9):5368-78. doi: 10.1128/AAC.00763-16. Print 2016 Sep.

    PMID: 27353271DERIVED

  • Lawitz E, Freilich B, Link J, German P, Mo H, Han L, Brainard DM, McNally J, Marbury T, Rodriguez-Torres M. A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus. J Viral Hepat. 2015 Dec;22(12):1011-9. doi: 10.1111/jvh.12435. Epub 2015 Jul 16.

    PMID: 26183611DERIVED

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis CLiver Diseases

Interventions

velpatasvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Gilead Clinical Study Information Center
Organization
Gilead Sciences
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)

Study Officials

  • Gilead Study Director

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2012

First Posted

December 4, 2012

Study Start

November 6, 2012

Primary Completion

March 15, 2013

Study Completion

January 24, 2014

Last Updated

December 16, 2020

Results First Posted

December 16, 2020

Record last verified: 2020-12

Locations

US(9)PR(1)