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AzTrials

Hepatitis C Virus InfectionPhase 3NCT02822794

Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

A Phase 3 study testing SOF/VEL and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 18 sites in Japan.

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 antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting… Read more about this study

Who is it for?
Ages 20 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
117 participants
Where
18 sitesJapan
Study dates
25 Jul 2016to 25 Aug 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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Genotype 1 or 2 HCV infection
  • Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy
  • Previously treated with a DAA-containing regimen of at least 4 week duration
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Who cannot join

None listed.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Japan18 sites

  • Study site

    Ehime

  • Study site

    Hiroshima

  • Study site

    Ichikawa-shi

  • Study site

    Iruma-gun

  • Study site

    Kashihara

  • Study site

    Kurume-shi

  • Study site

    Kyoto

  • Study site

    Maebashi

  • Study site

    Musashino-shi

  • Study site

    Nagoya

  • Study site

    Nishinomiya

  • Study site

    Ōgaki

  • Study site

    Okayama

  • Study site

    Ōmura

  • Study site

    Sapporo

  • Study site

    Suita

  • Study site

    Takamatsu

  • Study site

    Yamagata

Other trials in Japan

About this study

Official title: A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Subjects With Chronic Genotype 1 or 2 HCV Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.

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 tablet administered orally once daily

  • RBVDrug

    Also called REBETOL®

    Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)

Study groups in NCT02822794
Study groupRoleWhat they receive
SOF/VEL FDC + RBV 12 weeksExperimentalSOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection
Receives: Drug: SOF/VEL; Drug: RBV
SOF/VEL FDC + RBV 24 weeksExperimentalSOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection
Receives: Drug: SOF/VEL; Drug: RBV

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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

    Measured: Posttreatment Week 12

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

    Measured: Up to 24 weeks

Secondary outcomes (27)

  1. 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

  2. Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)

    SVR 24 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 at Week 1

    Measured: Week 1

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

    Measured: Week 2

  5. Percentage of Participants With HCV RNA < LLOQ at Week 3

    Measured: Week 3

  6. Percentage of Participants With HCV RNA < LLOQ at Week 4

    Measured: Week 4

  7. Percentage of Participants With HCV RNA < LLOQ at Week 5

    Measured: Week 5

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

    Measured: Week 6

  9. Percentage of Participants With HCV RNA < LLOQ at Week 8

    Measured: Week 8

  10. Percentage of Participants With HCV RNA < LLOQ at Week 10

    Measured: Week 10

  11. Percentage of Participants With HCV RNA < LLOQ at Week 12

    Measured: Week 12

  12. Percentage of Participants With HCV RNA < LLOQ at Week 16

    Measured: Week 16

  13. Percentage of Participants With HCV RNA < LLOQ at Week 20

    Measured: Week 20

  14. Percentage of Participants With HCV RNA < LLOQ at Week 24

    Measured: Week 24

  15. Change From Baseline in HCV RNA at Week 1

    Measured: Baseline; Week 1

  16. Change From Baseline in HCV RNA at Week 2

    Measured: Baseline; Week 2

  17. Change From Baseline in HCV RNA at Week 3

    Measured: Baseline; Week 3

  18. Change From Baseline in HCV RNA at Week 4

    Measured: Baseline; Week 4

  19. Change From Baseline in HCV RNA at Week 5

    Measured: Baseline; Week 5

  20. Change From Baseline in HCV RNA at Week 6

    Measured: Baseline; Week 6

  21. Change From Baseline in HCV RNA at Week 8

    Measured: Baseline; Week 8

  22. Change From Baseline in HCV RNA at Week 10

    Measured: Baseline; Week 10

  23. Change From Baseline in HCV RNA at Week 12

    Measured: Baseline; Week 12

  24. Change From Baseline in HCV RNA at Week 16

    Measured: Baseline; Week 16

  25. Change From Baseline in HCV RNA at Week 20

    Measured: Baseline; Week 20

  26. Change From Baseline in HCV RNA at Week 24

    Measured: Baseline; Week 24

  27. Percentage of Participants With Overall 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.

  1. First posted4 Jul 2016 (estimated)
  2. Study start25 Jul 2016
  3. Primary completion2 Jun 2017
  4. Study completion25 Aug 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02822794
Sponsor's protocol ID
GS-US-342-3921
Status last verified
Jul 2018
First submitted
30 Jun 2016
Last updated
14 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SOF/VEL and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 18 sites in Japan.

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 14 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 18 sites in Japan. 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 3 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 NCT02822794.

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 14 Nov 2018.

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