Chronic Genotype 4 HCVPhase 2NCT02081079
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection
A Phase 2 study testing LDV/SOF in people with Chronic Genotype 4 HCV and Chronic Genotype 5 HCV, run by Gilead Sciences at 5 sites in France.
Trial summary
This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA < lower… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Genotype 4 HCV, Chronic Genotype 5 HCV
- What is being tested?
- LDV/SOF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 5 sitesFrance
- Study dates
- Mar 2014to Feb 2015
- 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
- HCV RNA ≥ 10^4 IU/mL at screening
- Chronic genotype 4 or 5 HCV Infection
- Individuals may be treatment naive or treatment experienced
- Presence or absence of cirrhosis, a liver biopsy may be required
- Healthy according to medical history and physical examination with the exception of HCV diagnosis
- Agree to use two forms of highly effective contraception for the duration of the study
Who cannot join
- History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator
- Prior exposure to approved or experimental HCV specific direct acting antiviral(s) (DAA) other than NS3/4A protease inhibitors
- History of any other clinically significant chronic liver disease
- Evidence of or history of decompensated liver disease
- HIV or chronic hepatitis B (HBV) infection
- Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- Chronic use of immunosuppressive agents or immunomodulatory agents
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Study site
Clermont-Ferrand, 63003
Study site
Clichy, 92110
Study site
Limoges, 87042
Study site
Toulouse, 31059
Study site
Villejuif, 94800
About this study
Official title: A Phase 2, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection
This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.
- Conditions
- Chronic Genotype 4 HCV, Chronic Genotype 5 HCV
- Being tested
- LDV/SOF
- Keywords
- HCV GT 4, HCV GT 5
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
LDV/SOF (90/400 mg) FDC tablet administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Genotype 4 | Experimental | LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 4 hepatitis C virus (HCV) infection Receives: Drug: LDV/SOF |
| Genotype 5 | Experimental | LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 5 hepatitis C virus (HCV) infection 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 LDV/SOF Due to an Adverse Event
Measured: Up to 12 weeks
Secondary outcomes (3)
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Measured: Posttreatment Weeks 4 and 24
Percentage of Patients With Virologic Failure
Virologic failure was defined as either:
- 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); or
- Relapse:
- HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment
Measured: Up to posttreatment Week 24
Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12
Measured: Baseline; Weeks 2, 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2014
- Study completionFeb 2015
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 Chronic Genotype 4 HCVStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathryn Kersey, MSc, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081079
- Sponsor's protocol ID
- GS-US-337-1119
- Other IDs
- 2013-003978-27
- Status last verified
- Apr 2016
- First submitted
- 5 Mar 2014
- Last updated
- 19 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
Abergel A, Metivier S, Samuel D, Jiang D, Kersey K, Pang PS, Svarovskaia E, Knox SJ, Loustaud-Ratti V, Asselah T. Ledipasvir plus sofosbuvir for 12 weeks in patients with hepatitis C genotype 4 infection. Hepatology. 2016 Oct;64(4):1049-56. doi: 10.1002/hep.28706. Epub 2016 Jul 29.
PubMed 27351341Abergel A, Asselah T, Metivier S, Kersey K, Jiang D, Mo H, Pang PS, Samuel D, Loustaud-Ratti V. Ledipasvir-sofosbuvir in patients with hepatitis C virus genotype 5 infection: an open-label, multicentre, single-arm, phase 2 study. Lancet Infect Dis. 2016 Apr;16(4):459-64. doi: 10.1016/S1473-3099(15)00529-0. Epub 2016 Jan 21.
PubMed 26803446
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection
- ClinicalTrials.gov ID
- NCT02081079
- Acronym / sponsor ID
- GS-US-337-1119
- Conditions
- Chronic Genotype 4 HCV, Chronic Genotype 5 HCV
- Keywords
- HCV GT 4, HCV GT 5
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Posted 14 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genotype 4 | Experimental | Drug: LDV/SOFLDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 4 hepatitis C virus (HCV) infection |
| Genotype 5 | Experimental | Drug: LDV/SOFLDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 5 hepatitis C virus (HCV) infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HCV RNA ≥ 10^4 IU/mL at screening
- Chronic genotype 4 or 5 HCV Infection
- Individuals may be treatment naive or treatment experienced
- Presence or absence of cirrhosis, a liver biopsy may be required
- Healthy according to medical history and physical examination with the exception of HCV diagnosis
Key exclusion criteria (7 listed)
- History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator
- Prior exposure to approved or experimental HCV specific direct acting antiviral(s) (DAA) other than NS3/4A protease inhibitors
- History of any other clinically significant chronic liver disease
- Evidence of or history of decompensated liver disease
- HIV or chronic hepatitis B (HBV) infection
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-7977LDV/SOF (90/400 mg) FDC tablet administered orally once daily | Drug | Genotype 4, Genotype 5 |
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 LDV/SOF Due to an Adverse Event
Time frame: Up to 12 weeks
3 secondary outcomes
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time frame: Posttreatment Weeks 4 and 24
Percentage of Patients With Virologic Failure
Time frame: Up to posttreatment Week 24
Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12
Time frame: Baseline; Weeks 2, 4, 8, and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27351341Abergel A, Metivier S, Samuel D, Jiang D, Kersey K, Pang PS, Svarovskaia E, Knox SJ, Loustaud-Ratti V, Asselah T. Ledipasvir plus sofosbuvir for 12 weeks in patients with hepatitis C genotype 4 infection. Hepatology. 2016 Oct;64(4):1049-56. doi: 10.1002/hep.28706. Epub 2016 Jul 29.
- Derived from this study: PubMed 26803446Abergel A, Asselah T, Metivier S, Kersey K, Jiang D, Mo H, Pang PS, Samuel D, Loustaud-Ratti V. Ledipasvir-sofosbuvir in patients with hepatitis C virus genotype 5 infection: an open-label, multicentre, single-arm, phase 2 study. Lancet Infect Dis. 2016 Apr;16(4):459-64. doi: 10.1016/S1473-3099(15)00529-0. Epub 2016 Jan 21.
- 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.
Related trials for Chronic Genotype 4 HCV
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Treatment of CKD Patients With HCV
HCV Infection ( Genotype 4) in CKD Patients
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.
Kathryn Kersey, MSc study director
Gilead Sciences
5 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 in people with Chronic Genotype 4 HCV and Chronic Genotype 5 HCV, run by Gilead Sciences at 5 sites in France.
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 7 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 19 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 5 sites in France. 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 Jan 2016). 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 NCT02081079, 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 19 Nov 2018.