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Hepatitis C Virus InfectionPhase 3NCT02722837

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection

A Phase 3 study testing SOF/VEL in people with Hepatitis C Virus Infection, run by Gilead Sciences at 15 sites in 2 countries.

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 objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in participants with chronic 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?
SOF/VEL
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
15 sitesin 2 countries
Study dates
4 Apr 2016to 13 Sep 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 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 HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

Who cannot join

  • Any other chronic liver disease
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Clinical hepatic decompensation
  • Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
  • Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

Russia13 sites

  • Krasnoyarsk Regional Center of AIDS Prevention

    Krasnoyarsk

  • Central Research Institute of Epidemiology

    Moscow

  • Central Scientific-Research Institute of Epidemiology

    Moscow

  • City Clinical Hospital # 24

    Moscow

  • First Moscow Medical University I.M.Sechenov.

    Moscow

  • First Moscow State Medical University I.M. Sechenov

    Moscow

  • Limited Liability Company "Clinic Tour"

    Moscow

  • Scientific Research Institute of Nutrition

    Moscow

  • Sklifosovsky Scientific Research Institution of Emergency Care

    Moscow

  • Center for Prevention and Control of AIDS and Infectious Diseases

    Saint Petersburg

  • Kirov Medical Military Academy

    Saint Petersburg

  • North-Western State Medical University named after I.I. Mechnikov

    Saint Petersburg

  • LLC Medical Company "Hepatolog"

    Samara

Other trials in Russia

Sweden2 sites

  • Sahlgrenska Universitetsjukhuset

    Gothenburg

  • Karolinska University Hospital Huddinge

    Stockholm

Other trials in Sweden

About this study

Official title: A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) Infection

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.

Being tested
SOF/VEL
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

Study groups in NCT02722837
Study groupRoleWhat they receive
SOF/VELExperimentalSOF/VEL for 12 weeks
Receives: Drug: SOF/VEL

What is being measured

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

  1. 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) at 12 weeks after stopping study treatment.

    Measured: Posttreatment Week 12

  2. Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event

    Measured: Up to 12 weeks

Secondary outcomes (13)

  1. Percentage of Participants With HCV RNA < LLOQ 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

  2. Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)

    SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.

    Measured: Posttreatment Week 24

  3. Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1

    Measured: Week 1

  4. Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2

    Measured: Week 2

  5. Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4

    Measured: Week 4

  6. Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8

    Measured: Week 8

  7. Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12

    Measured: Week 12

  8. Change From Baseline in HCV RNA at Week 1

    Measured: Baseline (Day 1); Week 1

  9. Change From Baseline in HCV RNA at Week 2

    Measured: Baseline (Day 1); Week 2

  10. Change From Baseline in HCV RNA at Week 4

    Measured: Baseline (Day 1); Week 4

  11. Change From Baseline in HCV RNA at Week 8

    Measured: Baseline (Day 1); Week 8

  12. Change From Baseline in HCV RNA at Week 12

    Measured: Baseline (Day 1); Week 12

  13. Percentage of Participants With Virologic Failure

    Virologic failure was defined as:

    • 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 during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)

    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.

  1. First posted30 Mar 2016 (estimated)
  2. Study start4 Apr 2016
  3. Primary completion26 Jun 2017
  4. Study completion13 Sep 2017

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02722837
Sponsor's protocol ID
GS-US-342-1522
Other IDs
2015-003001-42, 2015
Status last verified
Jun 2018
First submitted
24 Mar 2016
Last updated
16 Nov 2018
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

  • Weiland O, Zhdanov K, Chulanov VP, McNabb BL, Lu S, Svarovskaia EU, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in a Genotype 1-3 HCV Infected Russian and Swedish Population: Results from a Phase 3, Prospective Trial [Abstract 1186]. Hepatology 2017;66 (1):639A.

  • Isakov V, Chulanov V, Abdurakhmanov D, Burnevich E, Nurmukhametova E, Kozhevnikova G, Gankina N, Zhuravel S, Romanova S, Hyland RH, Lu S, Svarovskaia ES, McNally J, Brainard DM, Ivashkin V, Morozov V, Bakulin I, Lagging M, Zhdanov K, Weiland O. Sofosbuvir/velpatasvir for the treatment of HCV: excellent results from a phase-3, open-label study in Russia and Sweden. Infect Dis (Lond). 2019 Feb;51(2):131-139. doi: 10.1080/23744235.2018.1535186. Epub 2018 Nov 30.

    PubMed 30499360

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SOF/VEL in people with Hepatitis C Virus Infection, run by Gilead Sciences at 15 sites in 2 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 2 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 15 sites in Russia, Sweden. 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 17 Jul 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 NCT02722837, 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.

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