NCT02738333

Brief Summary

The primary objectives of this study are to evaluate the antiviral efficacy of therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) and to evaluate the safety and tolerability of LDV/SOF FDC and sofosbuvir (SOF) + ribavirin (RBV) in participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
239

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

37 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

First Submitted

Initial submission to the registry

April 11, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

April 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2017

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 14, 2018

Completed
Last Updated

November 16, 2018

Status Verified

February 1, 2018

Enrollment Period

10 months

First QC Date

April 11, 2016

Results QC Date

February 12, 2018

Last Update Submit

October 19, 2018

Conditions

Hepatitis C Virus Infection

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 (21)

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

    Posttreatment Week 4

  • Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)

    Posttreatment Week 24

  • Percentage of Participants With HCV RNA < LLOQ at Week 1

    Week 1

  • Percentage of Participants With HCV RNA < LLOQ at Week 2

    Week 2

  • Percentage of Participants With HCV RNA < LLOQ at Week 3

    Week 3

  • +16 more secondary outcomes

Study Arms (3)

LDV/SOF (Cohort 1)

EXPERIMENTAL

LDV/SOF FDC for 12 weeks

Drug: LDV/SOF

SOF+RBV (Cohort 1)

EXPERIMENTAL

SOF+RBV for 12 weeks

Drug: SOFDrug: RBV

LDV/SOF (Cohort 2)

EXPERIMENTAL

Participants who are ineligible for or intolerant to RBV therapy will receive LDV/SOF FDC for 12 weeks.

Drug: LDV/SOF

Interventions

LDV/SOFDRUG

90/400 mg FDC tablet administered orally once daily

Also known as: Harvoni®, GS-5885/GS-7977
LDV/SOF (Cohort 1)LDV/SOF (Cohort 2)
SOFDRUG

400 mg tablet administered orally once daily

Also known as: Sovaldi®, GS-7977, PSI-7977
SOF+RBV (Cohort 1)
RBVDRUG

Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and \> 80 kg = 1000 mg)

Also known as: REBETOL®
SOF+RBV (Cohort 1)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic genotype 2 HCV-infected males and non-pregnant/non-lactating females
  • Aged 20 years or older
  • Treatment naive or treatment experienced
  • At least 20 subjects will have Child-Pugh-A compensated cirrhosis. In Cohort 2, participants must be ineligible or intolerant of RBV.

You may not qualify if:

  • Previous exposure to an NS5A or NS5B inhibitor
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Pregnant or nursing female or male with pregnant female partner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

Unknown Facility

Bunkyō City, Japan

Location

Unknown Facility

Chiba, Japan

Location

Unknown Facility

Chūō, Japan

Location

Unknown Facility

Ehime, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Fukuyama, Japan

Location

Unknown Facility

Gifu, Japan

Location

Unknown Facility

Ibaraki, Japan

Location

Unknown Facility

Ikeda, Japan

Location

Unknown Facility

Iruma-gun, Japan

Location

Unknown Facility

Izunokuni, Japan

Location

Unknown Facility

Kagoshima, Japan

Location

Unknown Facility

Kashihara, Japan

Location

Unknown Facility

Kitakyushu, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Maebashi, Japan

Location

Unknown Facility

Matsumoto, Japan

Location

Unknown Facility

Morioka, Japan

Location

Unknown Facility

Musashino, Japan

Location

Unknown Facility

Nagasaki, Japan

Location

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Nishinomiya, Japan

Location

Unknown Facility

Okayama, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Ōgaki, Japan

Location

Unknown Facility

Ōmura, Japan

Location

Unknown Facility

Saga, Japan

Location

Unknown Facility

Sagamihara, Japan

Location

Unknown Facility

Sapporo, Japan

Location

Unknown Facility

Sendai, Japan

Location

Unknown Facility

Suita, Japan

Location

Unknown Facility

tabashi City, Japan

Location

Unknown Facility

Takamatsu, Japan

Location

Unknown Facility

Ube, Japan

Location

Unknown Facility

Yamagata, Japan

Location

Unknown Facility

Yufu, Japan

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

ledipasvir, sofosbuvir drug combinationSofosbuvirRibavirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotidesRibonucleosidesNucleosides

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 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2016

First Posted

April 14, 2016

Study Start

April 12, 2016

Primary Completion

February 14, 2017

Study Completion

May 11, 2017

Last Updated

November 16, 2018

Results First Posted

March 14, 2018

Record last verified: 2018-02

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

JP(37)