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Hepatitis C Virus InfectionPhase 3ASTRAL-4NCT02201901

Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis

A Phase 3 study testing SOF/VEL and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 50 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 objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte… 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
268 participants
Where
50 sitesin 2 countries
Study dates
Jul 2014to Nov 2015
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

  • Willing and able to provide written informed consent
  • HCV RNA > 10^4 IU/mL at screening
  • Chronic HCV infection (≥ 6 months)
  • Confirmed CPT class B (7-9) at screening

Who cannot join

  • Current or prior history of solid organ transplantation, significant pulmonary disease, significant cardiac disease, or porphyria
  • Inability to exclude hepatocellular carcinoma (HCC) by imaging within 6 months of baseline/Day 1
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Screening ECG with clinically significant abnormalities
  • Prior exposure to SOF or any other nucleotide analogue HCV nonstructural protein 5B (NS5B) inhibitor or any HCV NS5A inhibitor
  • Laboratory results outside of acceptable ranges at screening

Trial locations and contacts

50 sites in 2 countries.

50 sites in 2 countries

United States49 sites

  • Study site

    Ann Arbor, Michigan

  • Study site

    Arlington, Texas, 76012

  • Study site

    Aurora, Colorado

  • Study site

    Baltimore, Maryland

  • Study site

    Boston, Massachusetts

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charlotte, North Carolina, 28204

  • Study site

    Chicago, Illinois

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Cleveland, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Detroit, Michigan

  • Study site

    Durham, North Carolina

  • Study site

    Fairfax, Virginia

  • Study site

    Gainesville, Florida

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Indianapolis, Indiana, 46237

  • Study site

    Jackson, Mississippi

  • Study site

    Jacksonville, Florida, 32256

  • Study site

    Kansas City, Kansas

  • Study site

    La Jolla, California

  • Study site

    Los Angeles, California, 90048

  • Study site

    Los Angeles, California

  • Study site

    Marietta, Georgia

  • Study site

    Miami, Florida

  • Study site

    Monroe, Louisiana, 71280

  • Study site

    Murray, Utah

  • Study site

    Nashville, Tennessee, 37211

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10029

  • Study site

    New York, New York, 10032

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    Pasadena, California

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Providence, Rhode Island, 02905

  • Study site

    Richmond, Virginia

  • Study site

    Rochester, Minnesota

  • Study site

    San Antonio, Texas

  • Study site

    San Francisco, California

  • Study site

    Santa Fe, New Mexico, 87505

  • Study site

    Seattle, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    Washington D.C., District of Columbia

Other trials in United States

Puerto Rico1 site

  • Study site

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection and Child-Pugh Class B Cirrhosis

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.

Being tested
SOF/VEL, RBV
Keywords
Sofosbuvir, Velpatasvir, SOF/VEL, GS-5816, Hepatitis C, HCV, Cirrhosis, CPT-B
Medical subject headings
Hepatitis C, Fibrosis

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 tablets administered orally once daily

  • RBVDrug

    Ribavirin (RBV) tablets 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 groups in NCT02201901
Study groupRoleWhat they receive
SOF/VEL 12 weeksExperimentalParticipants will receive SOF/VEL FDC for 12 weeks.
Receives: Drug: SOF/VEL
SOF/VEL+RBV 12 weeksExperimentalParticipants will receive SOF/VEL FDC plus RBV for 12 weeks.
Receives: Drug: SOF/VEL; Drug: RBV
SOF/VEL 24 weeksExperimentalParticipants will receive SOF/VEL FDC for 24 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) 12 weeks following the last dose of study drug.

    Measured: Posttreatment Week 12

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

    Measured: Up to 24 weeks plus 30 days

Secondary outcomes (6)

  1. Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

    Measured: Posttreatment Weeks 4 and 24

  2. Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

    Measured: Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

  3. Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

    Measured: Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

  4. Percentage of Participants With Virologic Failure

    Virologic failure was defined as

    • On-treatment virologic failure
    • HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,
    • > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment,
    • HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)
    • Relapse
    • HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement

    Measured: Up to Posttreatment Week 24

  5. Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score

    Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.

    Measured: Baseline to Posttreatment Week 24

  6. Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score

    CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease.

    Measured: Baseline 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 posted28 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionAug 2015
  4. Study completionNov 2015

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
268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02201901
Sponsor's protocol ID
GS-US-342-1137
Acronym
ASTRAL-4
Status last verified
Oct 2016
First submitted
24 Jul 2014
Last updated
15 Nov 2018
Data monitoring committee
Yes
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

  • Charlton MR, O'Leary JG, Bzowej NH, Muir AJ, Korenblat KM, Fenkel JM, et al. Sofosbuvir/Velapatasvir Fixed Dose Combination for the Treatment of HCV in Patients with Decompensated Liver Disease: The Phase 3 ASTRAL-4 Study. Hepatology 2015; 62 (6): 1387A-1388A.

  • Curry MP, O'Leary JG, Bzowej N, Muir AJ, Korenblat KM, Fenkel JM, Reddy KR, Lawitz E, Flamm SL, Schiano T, Teperman L, Fontana R, Schiff E, Fried M, Doehle B, An D, McNally J, Osinusi A, Brainard DM, McHutchison JG, Brown RS Jr, Charlton M; ASTRAL-4 Investigators. Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis. N Engl J Med. 2015 Dec 31;373(27):2618-28. doi: 10.1056/NEJMoa1512614. Epub 2015 Nov 16.

    PubMed 26569658

  • Asselah T, Charlton M, Feld J, Foster GR, McNally J, Brainard DM, et al. The ASTRAL Studies: Evaluation of SOF/GS-5816 Single-Tablet Regimen for the Treatment of Genotype 1-6 HCV Infection [Poster P1332]. J Hepatol 2015; 62:S855-S6.

  • Younossi ZM, Stepanova M, Charlton M, Curry MP, O'Leary JG, Brown RS, Hunt S. Patient-reported outcomes with sofosbuvir and velpatasvir with or without ribavirin for hepatitis C virus-related decompensated cirrhosis: an exploratory analysis from the randomised, open-label ASTRAL-4 phase 3 trial. Lancet Gastroenterol Hepatol. 2016 Oct;1(2):122-132. doi: 10.1016/S2468-1253(16)30009-7. Epub 2016 Aug 3.

    PubMed 28404069

  • Younossi ZM, Stepanova M, Feld J, Zeuzem S, Sulkowski M, Foster GR, Mangia A, Charlton M, O'Leary JG, Curry MP, Nader F, Henry L, Hunt S. Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis. Clin Gastroenterol Hepatol. 2017 Mar;15(3):421-430.e6. doi: 10.1016/j.cgh.2016.10.037. Epub 2016 Nov 12.

    PubMed 27847279

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 50 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 4 inclusion and 6 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 15 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 50 sites in United States, 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 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 14 Dec 2016). 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 NCT02201901, which also lists 5 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 15 Nov 2018.

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