NCT01975675

Brief Summary

This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or treatment-experienced Japanese participants with chronic genotype 1 HCV infection. Participants receive 12 weeks of treatment and continue assessments during a 24-week posttreatment follow-up period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
341

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

19 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

October 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
11 months until next milestone

Results Posted

Study results publicly available

June 26, 2015

Completed
Last Updated

November 16, 2018

Status Verified

June 1, 2015

Enrollment Period

8 months

First QC Date

October 29, 2013

Results QC Date

June 4, 2015

Last Update Submit

October 19, 2018

Conditions

Chronic HCV Infection

Outcome Measures

Primary Outcomes (3)

  • Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants

    SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

    Posttreatment Week 12

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

    SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 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 (2)

  • Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    Posttreatment Weeks 4 and 24

  • Percentage of Participants Experiencing Virologic Failure

    Up to Posttreatment Week 24

Study Arms (4)

LDV/SOF (treatment naive)

EXPERIMENTAL

Treatment-naive participants will receive LDV/SOF for 12 weeks.

Drug: LDV/SOF

LDV/SOF+RBV (treatment naive)

EXPERIMENTAL

Treatment-naive participants will receive LDV/SOF plus RBV for 12 weeks.

Drug: LDV/SOFDrug: RBV

LDV/SOF (treatment experienced)

EXPERIMENTAL

Treatment-experienced participants will receive LDV/SOF for 12 weeks.

Drug: LDV/SOF

LDV/SOF+RBV (treatment experienced)

EXPERIMENTAL

Treatment-experienced participants will receive LDV/SOF plus RBV for 12 weeks.

Drug: LDV/SOFDrug: RBV

Interventions

LDV/SOFDRUG

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

Also known as: GS-7977, PSI-7977, GS-5885
LDV/SOF (treatment experienced)LDV/SOF (treatment naive)LDV/SOF+RBV (treatment experienced)LDV/SOF+RBV (treatment naive)
RBVDRUG

RBV tablets 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: Copegus®
LDV/SOF+RBV (treatment experienced)LDV/SOF+RBV (treatment naive)

Eligibility Criteria

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

You may qualify if:

  • Body weight ≥ 40 kg
  • HCV RNA ≥ 10\^5 IU/mL at screening

You may not qualify if:

  • Current or prior history of any clinically-significant illness (other than HCV)
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of a non-HCV etiology
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Unknown Facility

Ichikawa, Chiba, 272-8516, Japan

Location

Unknown Facility

Kurume, Fukuoka, 830-0011, Japan

Location

Unknown Facility

Ōgaki, Gifu, 503-0864, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 060-8648, Japan

Location

Unknown Facility

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Unknown Facility

Matsumoto, Nagano, 390-8621, Japan

Location

Unknown Facility

Ōmura, Nagasaki, 856-8562, Japan

Location

Unknown Facility

Suita, Osaka, 565-0871, Japan

Location

Unknown Facility

Izunokuni, Shizuoka, 410-2295, Japan

Location

Unknown Facility

Chiyoda-ku, Tokyo, 101-8643, Japan

Location

Unknown Facility

Itabashi-ku, Tokyo, 173-8610, Japan

Location

Unknown Facility

Musashino, Tokyo, 180-8610, Japan

Location

Unknown Facility

Shinjuku, Tokyo, 162-8566, Japan

Location

Unknown Facility

Kofu, Yamanashi, 400-0027, Japan

Location

Unknown Facility

Akita, 010-0933, Japan

Location

Unknown Facility

Chiba, 260-0856, Japan

Location

Unknown Facility

Gifu, 500-8513, Japan

Location

Unknown Facility

Okayama, 700-8558, Japan

Location

Unknown Facility

Yamagata, 990-9585, Japan

Location

Related Publications (1)

  • Mizokami M, Yokosuka O, Takehara T, Sakamoto N, Korenaga M, Mochizuki H, Nakane K, Enomoto H, Ikeda F, Yanase M, Toyoda H, Genda T, Umemura T, Yatsuhashi H, Ide T, Toda N, Nirei K, Ueno Y, Nishigaki Y, Betular J, Gao B, Ishizaki A, Omote M, Mo H, Garrison K, Pang PS, Knox SJ, Symonds WT, McHutchison JG, Izumi N, Omata M. Ledipasvir and sofosbuvir fixed-dose combination with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with genotype 1 hepatitis C: an open-label, randomised, phase 3 trial. Lancet Infect Dis. 2015 Jun;15(6):645-53. doi: 10.1016/S1473-3099(15)70099-X. Epub 2015 Apr 8.

    PMID: 25863559DERIVED

MeSH Terms

Interventions

SofosbuvirledipasvirRibavirin

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

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

Study Officials

  • Steven Knox

    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

October 29, 2013

First Posted

November 5, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2014

Study Completion

August 1, 2014

Last Updated

November 16, 2018

Results First Posted

June 26, 2015

Record last verified: 2015-06

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(19)