Hepatitis C Virus InfectionPhase 3NCT04211909
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
A Phase 3 study testing SOF/VEL and SOF/VEL/VOX in people with Hepatitis C Virus Infection, run by Gilead Sciences at 22 sites in South Korea.
Trial summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC in participants with chronic HCV infection. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- SOF/VEL and SOF/VEL/VOX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 22 sitesSouth Korea
- Study dates
- 3 Jan 2020to 12 Nov 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic HCV infected males and non-pregnant/non-lactating females
- Treatment-naive or treatment-experienced individuals
- Non-cirrhosis or compensated cirrhosis at screening
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Who cannot join
None listed.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
South Korea22 sites
Inje University Busan Paik Hospital
Busan, 47392
Dong-A University Hospital
Busan, 48789
Pusan National University Hospital
Busan, 49241
Kyungpook National University Hospital
Daegu, 41944
Keimyung University Dongsan Hospital
Daegu, 42601
Chungnam National University Hospital
Daejeon, 35015
Chosun University Hospital
Gwangju, 501-717
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, 21431
Gachon University Gil Medical Center
Incheon, 405-760
Chonbuk National University Hospital
Jeonju, 54907
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-D, 13620
Seoul National University Hospital
Seoul, 03080
Severance Hospital
Seoul, 03722
VHS (Veterans Health Service) Medical Center
Seoul, 05368
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea, Seoul Saint Mary's Hospital
Seoul, 06591
Chung-Ang University Hospital
Seoul, 06973
SMG-SNU Boramae Medical Center
Seoul, 07061
Korea University Guro Hospital
Seoul, 08308
Ulsan University Hospital
Ulsan, 44033
Pusan National University Yangsan Hospital
Yangsan, 50612
About this study
Official title: A Phase 3b Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic HCV Infection
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC in participants with chronic HCV infection.
- Conditions
- Hepatitis C Virus Infection
- Being tested
- SOF/VEL, SOF/VEL/VOX
- 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 Epclusa®, GS-7977/GS-5816
400/100 mg FDC tablet orally once daily.
SOF/VEL/VOXDrug
Also called Vosevi ®, GS-7977/GS-5816/GS-9857
400/100/100 mg FDC tablet orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| SOF/VEL | Experimental | Participants with chronic HCV infection (genotype 1 or 2), who are treatment-naive or treatment-experienced with interferon (IFN)-based treatments will receive SOF/VEL for 12 weeks. Receives: Drug: SOF/VEL |
| SOF/VEL/VOX | Experimental | Participants with chronic HCV infection (genotype 1), who are treatment-experienced with nonstructural protein 5A (NS5A) direct-acting antiviral (DAA)-based treatments of at least 4 weeks duration will receive SOF/VEL/VOX for 12 weeks. Receives: Drug: SOF/VEL/VOX |
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) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment
SVR12 was defined as HCV RNA < LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.
Measured: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
Measured: First dose date up to 12 weeks plus 30 days
Secondary outcomes (5)
Percentage of Participants With SVR < LLOQ 4 Weeks After Discontinuation of Study Treatment
SVR4 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) 4 weeks after stopping study treatment.
Measured: Posttreatment Week 4
Percentage of Participants With Virologic Failure
Virologic failure was defined as:
On-treatment virologic failure:
- Breakthrough (HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values), 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: Baseline up to Posttreatment Week 12
Percentage of Participants With HCV RNA < LLOQ on Treatment
LLOQ was 15 IU/mL.
Measured: Week 2, Week 4, Week 8, Week 12
Change From Baseline in HCV RNA
Measured: Baseline, Week 2, Week 4, Week 8, Week 12
Number of Participants With Alanine Aminotransferase (ALT) Normalization
Number of participants with ALT normalization, defined as ALT > upper limit of normal (ULN) (ULN = 43 U/L) at baseline and ALT ≤ ULN, at each visit was presented.
Measured: Baseline, Week 2, Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start3 Jan 2020
- Primary completion12 Nov 2020
- Study completion12 Nov 2020
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 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
- NCT04211909
- Sponsor's protocol ID
- GS-US-342-5532
- Status last verified
- Sep 2021
- First submitted
- 23 Dec 2019
- Last updated
- 27 Oct 2021
- 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 https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic HCV Infection
- ClinicalTrials.gov ID
- NCT04211909
- Acronym / sponsor ID
- GS-US-342-5532
- Conditions
- Hepatitis C Virus Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Posted 27 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC in participants with chronic HCV infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOF/VEL | Experimental | Drug: SOF/VELParticipants with chronic HCV infection (genotype 1 or 2), who are treatment-naive or treatment-experienced with interferon (IFN)-based treatments will receive SOF/VEL for 12 weeks. |
| SOF/VEL/VOX | Experimental | Drug: SOF/VEL/VOXParticipants with chronic HCV infection (genotype 1), who are treatment-experienced with nonstructural protein 5A (NS5A) direct-acting antiviral (DAA)-based treatments of at least 4 weeks duration will receive SOF/VEL/VOX for 12 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic HCV infected males and non-pregnant/non-lactating females
- Treatment-naive or treatment-experienced individuals
- Non-cirrhosis or compensated cirrhosis at screening
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key exclusion criteria (0 listed)
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: Epclusa®, GS-7977/GS-5816400/100 mg FDC tablet orally once daily. | Drug | SOF/VEL |
| SOF/VEL/VOXAlso: Vosevi ®, GS-7977/GS-5816/GS-9857400/100/100 mg FDC tablet orally once daily. | Drug | SOF/VEL/VOX |
Primary outcome
Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment
Time frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
Time frame: First dose date up to 12 weeks plus 30 days
5 secondary outcomes
Percentage of Participants With SVR < LLOQ 4 Weeks After Discontinuation of Study Treatment
Time frame: Posttreatment Week 4
Percentage of Participants With Virologic Failure
Time frame: Baseline up to Posttreatment Week 12
Percentage of Participants With HCV RNA < LLOQ on Treatment
Time frame: Week 2, Week 4, Week 8, Week 12
Change From Baseline in HCV RNA
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12
Number of Participants With Alanine Aminotransferase (ALT) Normalization
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- 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 https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
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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
22 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 SOF/VEL and SOF/VEL/VOX in people with Hepatitis C Virus Infection, run by Gilead Sciences at 22 sites in South Korea.
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 0 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 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in South Korea. 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 27 Oct 2021). 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) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment (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?
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 27 Oct 2021.