NCT02226549

Brief Summary

This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV) ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1 hepatitis C virus (HCV) infection and cirrhosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

July 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 4, 2016

Completed
Last Updated

November 16, 2018

Status Verified

February 1, 2016

Enrollment Period

7 months

First QC Date

August 25, 2014

Results QC Date

February 5, 2016

Last Update Submit

October 19, 2018

Conditions

Hepatitis C Virus Infection

Keywords

hepatitis CGileadGS-9451

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

    SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

    Posttreatment Week 12

  • Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

    Up to 8 weeks

Secondary Outcomes (1)

  • Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

    Posttreatment Week 4

Study Arms (2)

LDV/SOF+VDV

EXPERIMENTAL

Participants will receive LDV/SOF+VDV for 8 weeks.

Drug: LDV/SOFDrug: VDV

LDV/SOF+VDV+RBV

EXPERIMENTAL

Participants will receive LDV/SOF+VDV+RBV for 8 weeks.

Drug: LDV/SOFDrug: VDVDrug: RBV

Interventions

LDV/SOFDRUG

LDV/SOF (90/400 mg) FDC tablet administered orally once daily

Also known as: Harvoni®, GS-5885/GS-7977
LDV/SOF+VDVLDV/SOF+VDV+RBV
VDVDRUG

VDV 80 mg tablet administered orally once daily

Also known as: GS-9451
LDV/SOF+VDVLDV/SOF+VDV+RBV
RBVDRUG

RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

LDV/SOF+VDV+RBV

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years, with chronic HCV genotype 1 infection
  • Documentation as treatment-experienced having received pegylated interferon (Peg-IFN) + RBV ≥ 4 weeks of duration without an additional agent in the regimen without achieving sustained viral response (SVR)
  • Presence of compensated cirrhosis
  • Screening laboratory values within defined thresholds
  • Must use specific contraceptive methods if female of childbearing potential or sexually active male
  • Not pregnant or a nursing female

You may not qualify if:

  • 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 subject treatment, assessment or compliance with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

ledipasvir, sofosbuvir drug combinationGS-9451

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Limitations and Caveats

There were no limitations affecting the analysis or results.

Results Point of Contact

Title
Clinical Trial Disclosures
Organization
Gilead Sciences
ClinicalTrialDisclosures@gilead.com

Study Officials

  • Robert Hyland, DPhil

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2014

First Posted

August 27, 2014

Study Start

July 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

November 16, 2018

Results First Posted

March 4, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
18 months after study completion
Access Criteria
A secured external environment with username, password, and RSA code.
More information

Locations

US(1)