NCT02413593

Brief Summary

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

15 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

April 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 14, 2017

Completed
Last Updated

November 16, 2018

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

April 7, 2015

Results QC Date

December 22, 2016

Last Update Submit

October 19, 2018

Conditions

Hepatitis C Virus Infection

Keywords

HCV genotype 3 (GT-3)HCVSustained Virologic ResponseDirect Acting AntiviralGS-7977GS-5885RibavirinSofosbuvirLedipasvirHepatitis CHepatitis C, Chronic

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 12 weeks

Secondary Outcomes (4)

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

    Posttreatment Week 4

  • Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12

    Weeks 1, 2, 4, 8, and 12

  • Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12

    Baseline; Weeks 1, 2, 4, 8, and 12

  • Percentage of Participants With Virologic Failure

    Up to Posttreatment Week 12

Study Arms (1)

LDV/SOF+RBV

EXPERIMENTAL

LDV/SOF FDC plus RBV for 12 weeks

Drug: LDV/SOFDrug: RBV

Interventions

LDV/SOFDRUG

90/400 mg FDC tablet administered orally once daily

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

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+RBV

Eligibility Criteria

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

You may qualify if:

  • Chronic genotype 3 HCV infection
  • HCV treatment-naive
  • HCV RNA \> 10,000 IU/mL at screening
  • Absence of cirrhosis or compensated cirrhosis
  • 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
  • Coinfection 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 the individual's treatment, assessment, or compliance with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Unknown Facility

Calgary, Alberta, T2N 4Z6, Canada

Location

Unknown Facility

Edmonton, Alberta, T5H 4B9, Canada

Location

Unknown Facility

Edmonton, Alberta, T6G 2B7, Canada

Location

Unknown Facility

Vancouver, British Columbia, V5Z 1H2, Canada

Location

Unknown Facility

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Unknown Facility

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Unknown Facility

Brampton, Ontario, L6R 3J7, Canada

Location

Unknown Facility

London, Ontario, N6A 5A5, Canada

Location

Unknown Facility

Ottawa, Ontario, K1H 8L6, Canada

Location

Unknown Facility

Toronto, Ontario, M5T 2S8, Canada

Location

Unknown Facility

Toronto, Ontario, M6H 3M1, Canada

Location

Unknown Facility

Vaughan, Ontario, L4L 4Y7, Canada

Location

Unknown Facility

Montreal, Quebec, H2L 4P9, Canada

Location

Unknown Facility

Montreal, Quebec, H2X 0A9, Canada

Location

Unknown Facility

Québec, G1V 4G2, Canada

Location

Related Publications (2)

  • Feld JJ, Ramji A, Shafran S, Willems B, Marotta P, Huchet E, et al. Ledipasvir/Sofosbuvir with ribavirin for 12 Weeks is effective and safe in treatment-naïve genotype 3 HCV-infected patients in Canada [Abstract SAT-183]. Presented at: The 51st Annual Congress of the European Association for the Study of Liver: The International Liver Congress (EASL); 2016 April 13-17; Barcelona, Spain.

    RESULT

  • Feld JJ, Ramji A, Shafran SD, Willems B, Marotta P, Huchet E, Vachon ML, Svarovskaia ES, Huang KC, Hyland RH, Yun C, Massetto B, Brainard DM, McHutchison JG, Tam E, Bailey R, Cooper C, Yoshida EM, Greenbloom S, Elkhashab M, Borgia S, Swain MG. Ledipasvir-Sofosbuvir Plus Ribavirin in Treatment-Naive Patients With Hepatitis C Virus Genotype 3 Infection: An Open-Label Study. Clin Infect Dis. 2017 Jul 1;65(1):13-19. doi: 10.1093/cid/cix289.

    PMID: 28535298DERIVED

MeSH Terms

Conditions

Hepatitis CHepatitis C, Chronic

Interventions

ledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

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

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 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 10, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

November 16, 2018

Results First Posted

February 14, 2017

Record last verified: 2016-12

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

CA(15)