Hepatitis C Virus InfectionPhase 3NCT02738333

Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection

A Phase 3 study testing LDV/SOF, SOF and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 37 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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)… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Hepatitis C Virus Infection
What is being tested?: LDV/SOF, SOF and RBV
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 239 participants
Where: 37 sitesJapan
Study dates: 12 Apr 2016to 11 May 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

Japan37 sites

Study site
Bunkyō City
Study site
Chiba
Study site
Chūō
Study site
Ehime
Study site
Fukuoka
Study site
Fukuyama
Study site
Gifu
Study site
Ibaraki
Study site
Ikeda
Study site
Iruma-gun
Study site
Izunokuni
Study site
Kagoshima
Study site
Kashihara
Study site
Kitakyushu
Study site
Kumamoto
Study site
Kyoto
Study site
Maebashi
Study site
Matsumoto
Study site
Morioka
Study site
Musashino
Study site
Nagasaki
Study site
Nagoya
Study site
Nishinomiya
Study site
Ōgaki
Study site
Okayama
Study site
Ōmura
Study site
Osaka
Study site
Saga
Study site
Sagamihara
Study site
Sapporo
Study site
Sendai
Study site
Suita
Study site
tabashi City
Study site
Takamatsu
Study site
Ube
Study site
Yamagata
Study site
Yufu

Other trials in Japan

About this study

Official title: A Phase 3b, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection

Conditions: Hepatitis C Virus Infection
Being tested: LDV/SOF, SOF, RBV
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LDV/SOFDrug
Also called Harvoni®, GS-5885/GS-7977
90/400 mg FDC tablet administered orally once daily
SOFDrug
Also called Sovaldi®, GS-7977, PSI-7977
400 mg tablet administered orally once daily
RBVDrug
Also called REBETOL®
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)

Study groups in NCT02738333
Study group	Role	What they receive
LDV/SOF (Cohort 1)	Experimental	LDV/SOF FDC for 12 weeks Receives: Drug: LDV/SOF
SOF+RBV (Cohort 1)	Experimental	SOF+RBV for 12 weeks Receives: Drug: SOF; Drug: RBV
LDV/SOF (Cohort 2)	Experimental	Participants who are ineligible for or intolerant to RBV therapy will receive LDV/SOF FDC for 12 weeks. Receives: Drug: LDV/SOF

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Measured: Up to 12 weeks

Secondary outcomes (21)

Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Measured: Posttreatment Week 4
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Measured: Posttreatment Week 24
Percentage of Participants With HCV RNA < LLOQ at Week 1
Measured: Week 1
Percentage of Participants With HCV RNA < LLOQ at Week 2
Measured: Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 3
Measured: Week 3
Percentage of Participants With HCV RNA < LLOQ at Week 4
Measured: Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 5
Measured: Week 5
Percentage of Participants With HCV RNA < LLOQ at Week 6
Measured: Week 6
Percentage of Participants With HCV RNA < LLOQ at Week 8
Measured: Week 8
Percentage of Participants With HCV RNA < LLOQ at Week 10
Measured: Week 10
Percentage of Participants With HCV RNA < LLOQ at Week 12
Measured: Week 12
Change From Baseline in HCV RNA at Week 1
Measured: Baseline; Week 1
Change From Baseline in HCV RNA at Week 2
Measured: Baseline; Week 2
Change From Baseline in HCV RNA at Week 3
Measured: Baseline; Week 3
Change From Baseline in HCV RNA at Week 4
Measured: Baseline; Week 4
Change From Baseline in HCV RNA at Week 5
Measured: Baseline; Week 5
Change From Baseline in HCV RNA at Week 6
Measured: Baseline; Week 6
Change From Baseline in HCV RNA at Week 8
Measured: Baseline; Week 8
Change From Baseline in HCV RNA at Week 10
Measured: Baseline; Week 10
Change From Baseline in HCV RNA at Week 12
Measured: Baseline; Week 12
Percentage of Participants With Overall Virologic Failure
Virologic failure was defined as:
- On-treatment virologic failure:
- Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
- Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
- Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
- Virologic relapse:
- Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Measured: Up to Posttreatment Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Apr 201611 May 2017

First posted14 Apr 2016 (estimated)
Study start12 Apr 2016
Primary completion14 Feb 2017
Study completion11 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 239 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02738333
Sponsor's protocol ID: GS-US-337-1903
Status last verified: Feb 2018
First submitted: 11 Apr 2016
Last updated: 16 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatitis C Virus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3b, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection
ClinicalTrials.gov ID: NCT02738333
Acronym / sponsor ID: GS-US-337-1903
Conditions: Hepatitis C Virus Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 239 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 12 Apr 2016 (actual)
Primary completion: 14 Feb 2017 (actual)
Study completion: 11 May 2017 (actual)
First posted: 14 Apr 2016 (estimated)
Results: Posted 14 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
LDV/SOF (Cohort 1)	Experimental	Drug: LDV/SOFLDV/SOF FDC for 12 weeks
SOF+RBV (Cohort 1)	Experimental	Drug: SOF, Drug: RBVSOF+RBV for 12 weeks
LDV/SOF (Cohort 2)	Experimental	Drug: LDV/SOFParticipants who are ineligible for or intolerant to RBV therapy will receive LDV/SOF FDC for 12 weeks.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LDV/SOFAlso: Harvoni®, GS-5885/GS-797790/400 mg FDC tablet administered orally once daily	Drug	LDV/SOF (Cohort 1), LDV/SOF (Cohort 2)
SOFAlso: Sovaldi®, GS-7977, PSI-7977400 mg tablet administered orally once daily	Drug	SOF+RBV (Cohort 1)
RBVAlso: REBETOL®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)	Drug	SOF+RBV (Cohort 1)

Primary outcome

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Time frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 12 weeks

21 secondary outcomes

Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
Time frame: Posttreatment Week 4
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
Time frame: Posttreatment Week 24
Percentage of Participants With HCV RNA < LLOQ at Week 1
Time frame: Week 1
Percentage of Participants With HCV RNA < LLOQ at Week 2
Time frame: Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 3
Time frame: Week 3
Percentage of Participants With HCV RNA < LLOQ at Week 4
Time frame: Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 5
Time frame: Week 5
Percentage of Participants With HCV RNA < LLOQ at Week 6
Time frame: Week 6
Percentage of Participants With HCV RNA < LLOQ at Week 8
Time frame: Week 8
Percentage of Participants With HCV RNA < LLOQ at Week 10
Time frame: Week 10
Percentage of Participants With HCV RNA < LLOQ at Week 12
Time frame: Week 12
Change From Baseline in HCV RNA at Week 1
Time frame: Baseline; Week 1
Change From Baseline in HCV RNA at Week 2
Time frame: Baseline; Week 2
Change From Baseline in HCV RNA at Week 3
Time frame: Baseline; Week 3
Change From Baseline in HCV RNA at Week 4
Time frame: Baseline; Week 4
Change From Baseline in HCV RNA at Week 5
Time frame: Baseline; Week 5
Change From Baseline in HCV RNA at Week 6
Time frame: Baseline; Week 6
Change From Baseline in HCV RNA at Week 8
Time frame: Baseline; Week 8
Change From Baseline in HCV RNA at Week 10
Time frame: Baseline; Week 10
Change From Baseline in HCV RNA at Week 12
Time frame: Baseline; Week 12
Percentage of Participants With Overall Virologic Failure
Time frame: Up to Posttreatment Week 24

Results and safety

Results posted to the registry on 14 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LDV/SOF (Cohort 1)	106	104
SOF+RBV (Cohort 1)	108	108
LDV/SOF (Cohort 2)	25	25

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

Time frame: Posttreatment Week 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	LDV/SOF (Cohort 1) n = 106	SOF+RBV (Cohort 1) n = 108	LDV/SOF (Cohort 2) n = 25
Value	96.2 (90.6 to 99.0)	95.4 (89.5 to 98.5)	96.0 (79.6 to 99.9)

LDV/SOF (Cohort 1) vs SOF+RBV (Cohort 1): Difference in proportions: 0.9 (95% CI -5.3 to 7.1)

Population analysed: Full Analysis Set: participants who were randomized and took at least 1 dose of study drug.

Primary outcome: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Time frame: Up to 12 weeks. Number. Unit: percentage of participants

Measure	LDV/SOF (Cohort 1) n = 106	SOF+RBV (Cohort 1) n = 108	LDV/SOF (Cohort 2) n = 25
Value	0.9	1.9	0

Population analysed: Safety Analysis Set

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 weeks plus 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LDV/SOF (Cohort 1)	1 of 106 (0.9%)	25 of 106 (23.6%)	1 of 106
SOF+RBV (Cohort 1)	1 of 108 (0.9%)	48 of 108 (44.4%)	0 of 108
LDV/SOF (Cohort 2)	1 of 25 (4%)	7 of 25 (28%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilead Study Director study director

Gilead Sciences

37 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LDV/SOF, SOF and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 37 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (time frame: Posttreatment Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02738333.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.