Hepatitis C Virus InfectionPhase 2NCT02413593

Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection

A Phase 2 study testing LDV/SOF and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 15 sites in Canada.

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

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C Virus Infection
What is being tested?: LDV/SOF and RBV
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 111 participants
Where: 15 sitesCanada
Study dates: Apr 2015to Jan 2016
Phase: Phase 2
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Canada15 sites

Study site
Brampton, Ontario, L6R 3J7
Study site
Calgary, Alberta, T2N 4Z6
Study site
Edmonton, Alberta, T5H 4B9
Study site
Edmonton, Alberta, T6G 2B7
Study site
London, Ontario, N6A 5A5
Study site
Montreal, Quebec, H2L 4P9
Study site
Montreal, Quebec, H2X 0A9
Study site
Ottawa, Ontario, K1H 8L6
Study site
Québec, G1V 4G2
Study site
Toronto, Ontario, M5T 2S8
Study site
Toronto, Ontario, M6H 3M1
Study site
Vancouver, British Columbia, V5Z 1H2
Study site
Vancouver, British Columbia, V5Z 1M9
Study site
Vancouver, British Columbia, V6Z 2K5
Study site
Vaughan, Ontario, L4L 4Y7

Other trials in Canada

About this study

Official title: A Phase 2 Open- Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naïve Patients With Chronic HCV Genotype 3 Infection

Conditions: Hepatitis C Virus Infection
Being tested: LDV/SOF, RBV
Keywords: HCV genotype 3 (GT-3), HCV, Sustained Virologic Response, Direct Acting Antiviral, GS-7977, GS-5885, Ribavirin, Sofosbuvir, Ledipasvir, Hepatitis C, Hepatitis C, Chronic
Medical subject headings: Hepatitis C, Hepatitis C, Chronic

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
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)

Study groups in NCT02413593
Study group	Role	What they receive
LDV/SOF+RBV	Experimental	LDV/SOF FDC plus RBV for 12 weeks Receives: Drug: LDV/SOF; Drug: RBV

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 (4)

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 HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12
Measured: Weeks 1, 2, 4, 8, and 12
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Measured: Baseline; Weeks 1, 2, 4, 8, and 12
Percentage of Participants With 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 12

Timeline

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

Apr 2015Jan 2016

First posted10 Apr 2015 (estimated)
Study startApr 2015
Primary completionDec 2015
Study completionJan 2016

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.
Publications (2)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02413593
Sponsor's protocol ID: GS-US-337-1701
Status last verified: Dec 2016
First submitted: 7 Apr 2015
Last updated: 16 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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.

Publications

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.
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.
PubMed 28535298

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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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 2 Open- Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naïve Patients With Chronic HCV Genotype 3 Infection
ClinicalTrials.gov ID: NCT02413593
Acronym / sponsor ID: GS-US-337-1701
Conditions: Hepatitis C Virus Infection
Keywords: HCV genotype 3 (GT-3), HCV, Sustained Virologic Response, Direct Acting Antiviral, GS-7977, GS-5885, Ribavirin, Sofosbuvir
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 111 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Apr 2015
Primary completion: Dec 2015 (actual)
Study completion: Jan 2016 (actual)
First posted: 10 Apr 2015 (estimated)
Results: Posted 14 Feb 2017

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LDV/SOF+RBV	Experimental	Drug: LDV/SOF, Drug: RBVLDV/SOF FDC plus RBV for 12 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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

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+RBV
RBVTablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)	Drug	LDV/SOF+RBV

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

4 secondary outcomes

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

Results and safety

Results posted to the registry on 14 Feb 2017, 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+RBV	111	107

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+RBV n = 111
Value	89.2 (81.9 to 94.3)

Population analysed: Full Analysis Set: all enrolled participants who received 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+RBV n = 111
Value	0.9

Population analysed: Safety Analysis Set

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to 30 days after last dose of study drug (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+RBV	4 of 111 (3.6%)	89 of 111 (80.2%)	Not reported

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.
Results publicationFeld 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.
Derived from this study: PubMed 28535298Feld 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.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LDV/SOF and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 15 sites in Canada.

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 6 inclusion and 6 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 15 sites in Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Feb 2017). 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 NCT02413593, which also lists 2 linked publications.

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.