Hepatitis C Virus InfectionPhase 2NCT02300103
Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study
A Phase 2 study testing SOF/VEL and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 30 sites in 4 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve… 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?
- SOF/VEL and RBV
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 30 sitesin 4 countries
- Study dates
- 1 Dec 2014to 15 Sep 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
- Willing and able to provide written informed consent
- HCV genotype determined by the Central Laboratory
- HCV RNA > LLOQ at screening
- Participated and completed a Gilead sponsored HCV treatment study of direct acting antiviral (DAA) containing regimens.
- Male and female of childbearing potential must agree to use protocol specified method(s) of contraception
Who cannot join
- Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
- Screening ECG with clinically significant abnormalities
- Laboratory results outside of acceptable ranges at screening
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial locations and contacts
30 sites in 4 countries.
30 sites in 4 countries
United States23 sites
Study site
Aurora, Colorado
Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Dallas, Texas
Study site
Durham, North Carolina
Study site
Falls Church, Virginia
Study site
Fayetteville, North Carolina
Study site
Gainesville, Florida
Study site
Germantown, Tennessee
Study site
Hillsborough, New Jersey
Study site
Jacksonville, Florida
Study site
Manhasset, New York
Study site
Miami, Florida
Study site
Nashville, Tennessee
Study site
Norfolk, Virginia
Study site
Orlando, Florida
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Richmond, Virginia
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
San Marcos, California
Study site
Wellington, Florida
Australia4 sites
Study site
Darlinghurst, New South Wales
Study site
Fitzroy, Victoria
Study site
Melbourne, Victoria
Study site
Murdoch, Western Australia
About this study
Official title: An Open Label Study to Evaluate The Efficacy And Safety Of Sofosbuvir/GS-5816 Fixed Dose Combination With Ribavirin For 24 Weeks In Chronic HCV Infected Subjects Who Participated In A Prior Gilead Sponsored HCV Treatment Study
The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).
- Conditions
- Hepatitis C Virus Infection
- Being tested
- SOF/VEL, 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.
SOF/VELDrug
Also called GS-7977/GS-5816, Epclusa®
400/100 mg FDC tablet administered orally once daily
RBVDrug
Tablet (s) 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 group | Role | What they receive |
|---|---|---|
| SOF/VEL+RBV | Experimental | Participants will receive SOF/VEL fixed dose combination (FDC) and RBV for 24 weeks. Receives: Drug: SOF/VEL; 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 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Measured: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Measured: Up to 24 weeks
Secondary outcomes (4)
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug.
Measured: Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ On-treatment
Measured: Baseline to Week 24
HCV RNA Change From Baseline
Measured: Baseline to Week 24
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 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study start1 Dec 2014
- Primary completion2 Jul 2016
- Study completion15 Sep 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 (1)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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300103
- Sponsor's protocol ID
- GS-US-342-1553
- Status last verified
- Jun 2017
- First submitted
- 20 Nov 2014
- 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.
Publications
Gane EJ, Shiffman ML, Etzkorn K, Morelli G, Stedman C, Davis MN, et al. Sofosbuvir/Velpatasvir in Combination With Ribavirin for 24 Weeks is Effective Retreatment for Patients Who Failed Prior NS5A Containing DAA Regimens: Results of the GS-US-342-1553 Study [Abstract PS024]. J Hepatology 2016;64:S147-S8.
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
- An Open Label Study to Evaluate The Efficacy And Safety Of Sofosbuvir/GS-5816 Fixed Dose Combination With Ribavirin For 24 Weeks In Chronic HCV Infected Subjects Who Participated In A Prior Gilead Sponsored HCV Treatment Study
- ClinicalTrials.gov ID
- NCT02300103
- Acronym / sponsor ID
- GS-US-342-1553
- Conditions
- Hepatitis C Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 2 Jul 2016 (actual)
- Study completion
- 15 Sep 2016 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Posted 28 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOF/VEL+RBV | Experimental | Drug: SOF/VEL, Drug: RBVParticipants will receive SOF/VEL fixed dose combination (FDC) and RBV for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing and able to provide written informed consent
- HCV genotype determined by the Central Laboratory
- HCV RNA > LLOQ at screening
- Participated and completed a Gilead sponsored HCV treatment study of direct acting antiviral (DAA) containing regimens.
- Male and female of childbearing potential must agree to use protocol specified method(s) of contraception
Key exclusion criteria (5 listed)
- Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
- Screening ECG with clinically significant abnormalities
- Laboratory results outside of acceptable ranges at screening
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- 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 |
|---|---|---|
| SOF/VELAlso: GS-7977/GS-5816, Epclusa®400/100 mg FDC tablet administered orally once daily | Drug | SOF/VEL+RBV |
| RBVTablet (s) 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 | SOF/VEL+RBV |
Primary outcome
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Time frame: Posttreatment Week 12
SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 24 weeks
4 secondary outcomes
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time frame: Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ On-treatment
Time frame: Baseline to Week 24
HCV RNA Change From Baseline
Time frame: Baseline to Week 24
Percentage of Participants With Virologic Failure
Time frame: Up to Posttreatment Week 24
Results and safety
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 publicationGane EJ, Shiffman ML, Etzkorn K, Morelli G, Stedman C, Davis MN, et al. Sofosbuvir/Velpatasvir in Combination With Ribavirin for 24 Weeks is Effective Retreatment for Patients Who Failed Prior NS5A Containing DAA Regimens: Results of the GS-US-342-1553 Study [Abstract PS024]. J Hepatology 2016;64:S147-S8.
- 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
30 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SOF/VEL and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 30 sites in 4 countries.
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 5 inclusion and 5 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 30 sites in United States, Australia, New Zealand, Puerto Rico. 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 28 Jul 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 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 NCT02300103, which also lists 1 linked publication.
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.