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AzTrials

Hepatitis C Virus InfectionPhase 3NCT02996682

Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis

A Phase 3 study testing SOF/VEL and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 33 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 objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection and decompensated cirrhosis. 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
102 participants
Where
33 sitesJapan
Study dates
26 Dec 2016to 8 May 2018
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

  • Chronic HCV-infected males and non-pregnant/non-lactating females
  • Treatment naive or treatment experienced individuals
  • Child-Pugh-Turcotte Score 7-12 at screening
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Who cannot join

None listed.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

Japan33 sites

  • Study site

    Bunkyō City

  • Study site

    Chiba

  • Study site

    Chūō

  • Study site

    Ehime

  • Study site

    Fukui

  • Study site

    Fukuyama-shi

  • Study site

    Hiroshima

  • Study site

    Ibaraki

  • Study site

    Ichikawa

  • Study site

    Iizuka

  • Study site

    Iruma

  • Study site

    Izunokuni

  • Study site

    Kashibara

  • Study site

    Kofu

  • Study site

    Kumamoto

  • Study site

    Kurume

  • Study site

    Kyoto

  • Study site

    Miyazaki

  • Study site

    Morioka

  • Study site

    Musashino

  • Study site

    Nagoya

  • Study site

    Nishinomiya

  • Study site

    Okayama

  • Study site

    Ōmura

  • Study site

    Osaka

  • Study site

    Sapporo

  • Study site

    Sendai

  • Study site

    Shimonoseki, Yamaguchi

  • Study site

    Shimotsuga-gun

  • Study site

    Suita

  • Study site

    Takamatsu

  • Study site

    Ube

  • Study site

    Yamagata

Other trials in Japan

About this study

Official title: A Multicenter, Randomized, Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Decompensated Cirrhosis

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection and decompensated cirrhosis.

Being tested
SOF/VEL, RBV
Keywords
Communicable Diseases, Hepatitis, Hepatitis C, Virus Diseases, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Velpatasvir, RNA Virus Infections, Ribavirin, Sofosbuvir, Antiviral Agents, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Anti-Infective Agents, Decompensated Cirrhosis
Medical subject headings
Hepatitis C, Communicable Diseases, Hepatitis, Virus Diseases, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, RNA Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOF/VELDrug

    Also called Epclusa®

    400/100 mg FDC tablet administered orally once daily

  • RBVDrug

    Also called Rebetol®

    Capsules administered orally in a divided daily dose

Study groups in NCT02996682
Study groupRoleWhat they receive
SOF/VELExperimentalSOF/VEL for 12 weeks
Receives: Drug: SOF/VEL
SOF/VEL + RBVExperimentalSOF/VEL + RBV for 12 weeks
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 Discontinued Treatment (SOF/VEL or RBV) Early Due to an Adverse Event

    Measured: Up to 12 weeks

Secondary outcomes (7)

  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)

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

    Measured: Posttreatment Week 24

  3. Percentage of Participants Who Had HCV RNA < LLOQ by Visit While on Treatment

    Measured: Up to 12 weeks

  4. Change From Baseline in HCV RNA

    Measured: Baseline and up to 12 weeks

  5. Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score

    MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. "No change" was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; "Decrease" was assigned for differences that were less than or equal to -2; and "Increase" was assigned for values that were greater than or equal to 2.

    Measured: Baseline to Posttreatment Week 24

  6. Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class

    CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. CPT scores were calculated using prothrombin activation percentage for the coagulation parameter per Japan's standard.

    Measured: Baseline to Posttreatment Week 24

  7. 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 posted19 Dec 2016 (estimated)
  2. Study start26 Dec 2016
  3. Primary completion13 Feb 2018
  4. Study completion8 May 2018

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
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02996682
Sponsor's protocol ID
GS-US-342-4019
Status last verified
Feb 2019
First submitted
15 Dec 2016
Last updated
26 Feb 2019
Data monitoring committee
Yes
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/about/ethics-and-code-of-conduct/policies.

Publications

  • Takehara T, Kurosaki M, Tanaka Y, Tatsumi T, Ikeda F, Takikawa Y, et al. Sofosbuvir/Velpatasvir with or without Ribavirin for 12 Weeks in HCV-Infected Japanese Subjects with Decompensated Cirrhosis [Presentation]. 54th Annual Meeting of Japan Society of Hepatology; 2018 June 15; Osaka, Japan.

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 33 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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 26 Feb 2019). 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 NCT02996682, 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 26 Feb 2019.

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